chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Psoriasis, Pyrexia
Clinical narrative: PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP), PYREXIA (Fever) and FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS).   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. In 2021, the patient experienced PYREXIA (Fever) and FATIGUE (Fatigue). On an unknown date, the patient experienced PSORIASIS (PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP). At the time of the report, PSORIASIS (PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP) had not resolved and PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            There was no reported medical history.  Concomitant drugs not reported. On unknown dates, the patient experienced PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP and DID NOT FEEL HUMIRA WAS WORKING. In 2021, the patient experienced FATIGUE and FEVER.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of FATIGUE and FEVER with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of PSORIASIS BREAK OUT ON ELBOWS AND RIGHT ELBOW/PLAQUES ON KNEES AND ELBOWS/PLAQUE PSORIASIS FLARE UP with HUMIRA(ADALIMUMAB) was a reasonable possibility and for the event of DID NOT FEEL HUMIRA WAS WORKING 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.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Live Significant Follow-up received: Age was added. Batch number for humira was added. Moderna booster dose regimen was added and administration dates for dose 1 and dose 2 were added.  New events fatigue and lack of drug effect were added. As reported term for the event Psoriasis flare-up was updated. Onset date for the event fever was added. Causality for fever was updated for Moderna suspect.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Fatigue after COVID vaccine; Sore arm after COVID vaccine; Headache after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after COVID vaccine), VACCINATION SITE PAIN (Sore arm after COVID vaccine) and HEADACHE (Headache after COVID vaccine) in a 51-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 Ulcerative colitis.    No Medical History information was reported.   In June 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue after COVID vaccine), VACCINATION SITE PAIN (Sore arm after COVID vaccine) and HEADACHE (Headache after COVID vaccine). In 2021, FATIGUE (Fatigue after COVID vaccine) and VACCINATION SITE PAIN (Sore arm after COVID vaccine) had resolved. In October 2021, HEADACHE (Headache after COVID vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Humira found in system. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Injection site pain; Headache; Fatigue; Injection site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE PAIN (Injection site pain) and HEADACHE (Headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 01-Aug-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INJECTION SITE PRURITUS (Injection site pruritus). In March 2021, the patient experienced FATIGUE (Fatigue). March 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). In March 2021, FATIGUE (Fatigue) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site pruritus) had not resolved and INJECTION SITE PAIN (Injection site pain) and HEADACHE (Headache) outcome was unknown.            No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of Fatigue, pruritus/itching at injection sites, injection site more pain and headache 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. No treatment medicine were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID FOR ONE WEEK AND HAD MILD SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID FOR ONE WEEK AND HAD MILD SYMPTOMS) 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 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) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID FOR ONE WEEK AND HAD MILD SYMPTOMS). At the time of the report, COVID-19 (COVID FOR ONE WEEK AND HAD MILD SYMPTOMS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. An elderly female patient in treatment with ADALIMUMAB (HUMIRA) for Ulcerative colitis, experienced non serious event of COVID-19 (AESI) after receiving mRNA-1273 vaccine. Vaccination date and onset date of the event were not provided, latency cannot be assessed. Event lasted one week and she had mild symptoms. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. An elderly female patient in treatment with ADALIMUMAB (HUMIRA) for Ulcerative colitis, experienced non serious event of COVID-19 (AESI) after receiving mRNA-1273 vaccine. Vaccination date and onset date of the event were not provided, latency cannot be assessed. Event lasted one week and she had mild symptoms. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pruritus, Vaccination site pain
Clinical narrative: ARM WAS SORE AFTER RECEIVING BOOSTER COVID 19 VACCINE; INCREASED IN ITCHING; INCREASE IN PAIN; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (INCREASED IN ITCHING), PAIN (INCREASE IN PAIN) and VACCINATION SITE PAIN (ARM WAS SORE AFTER RECEIVING BOOSTER COVID 19 VACCINE) in a 51-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.    Concomitant products included TAVABOROLE, CLOBETASOL PROPIONATE (CLOBETASOL 0.05%), OMEPRAZOLE, ESTROVEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 28-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRURITUS (INCREASED IN ITCHING) and PAIN (INCREASE IN PAIN). On 03-Sep-2021, the patient experienced VACCINATION SITE PAIN (ARM WAS SORE AFTER RECEIVING BOOSTER COVID 19 VACCINE). At the time of the report, PRURITUS (INCREASED IN ITCHING), PAIN (INCREASE IN PAIN) and VACCINATION SITE PAIN (ARM WAS SORE AFTER RECEIVING BOOSTER COVID 19 VACCINE) outcome was unknown.            Concomitant product use was not provided by the reporter.   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, UNK
Symptoms: Dizziness, Fatigue, Furuncle, Injection site swelling, Pyrexia
Clinical narrative: Recurring skin boils; Dizzy; Injection site swelling; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Recurring skin boils), DIZZINESS (Dizzy), INJECTION SITE SWELLING (Injection site swelling), PYREXIA (Fever) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced FURUNCLE (Recurring skin boils), DIZZINESS (Dizzy), INJECTION SITE SWELLING (Injection site swelling), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, FURUNCLE (Recurring skin boils) and INJECTION SITE SWELLING (Injection site swelling) had not resolved, DIZZINESS (Dizzy) and PYREXIA (Fever) outcome was unknown and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events with Humira and Moderna Vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Skin exfoliation
Clinical narrative: Skin loss; On 10 Dec 2020, patient received first dose and On 25 Feb 2021, patient received second dose; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Skin loss), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Dec 2020, patient received first dose and On 25 Feb 2021, patient received second dose) and CHILLS (Shivering) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 10-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced SKIN EXFOLIATION (Skin loss), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Dec 2020, patient received first dose and On 25 Feb 2021, patient received second dose) and CHILLS (Shivering). At the time of the report, SKIN EXFOLIATION (Skin loss), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Dec 2020, patient received first dose and On 25 Feb 2021, patient received second dose) and CHILLS (Shivering) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.  On an unknown date, the patient experienced shivering due to skin loss.  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: 28.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Headache, Pain in extremity, Rash
Clinical narrative: Rash; Leg pain; Knee pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PAIN IN EXTREMITY (Leg pain), HEADACHE (Headache) and ARTHRALGIA (Knee pain) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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) Solution for injection in pre-filled pen, Citrate Free. In 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced RASH (Rash), PAIN IN EXTREMITY (Leg pain) and ARTHRALGIA (Knee pain). At the time of the report, RASH (Rash), PAIN IN EXTREMITY (Leg pain), HEADACHE (Headache) and ARTHRALGIA (Knee pain) had not resolved.            On unknown dates, the patient experienced rash, leg hurts and knee pain. In 2021, the patient experienced headache after the covid vaccine. 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    Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Significant follow up: event added.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abscess, Fatigue, Insomnia, Presyncope
Clinical narrative: Near fainting; Abscess; Sleeplessness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Near fainting), ABSCESS (Abscess), INSOMNIA (Sleeplessness) and FATIGUE (Tiredness) in a 33-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 Hidradenitis suppurativa.    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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PRESYNCOPE (Near fainting), ABSCESS (Abscess), INSOMNIA (Sleeplessness) and FATIGUE (Tiredness). At the time of the report, PRESYNCOPE (Near fainting), ABSCESS (Abscess), INSOMNIA (Sleeplessness) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown date, the patient experienced almost fainted for covid shot, three abscesses and feels tired due to lack of sleep. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the events of almost fainted for covid shot, three abscesses, feels tired due to lack of sleep unknown onset and feels tired due to lack of sleep unknown onset 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: Chills, Hot flush, Nausea, Psoriasis, Scar
Clinical narrative: Psoriasis/spots and scarring/psoriasis sploches on waist/torso/arms; Scarring/spots; Hot flashes; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis/spots and scarring/psoriasis sploches on waist/torso/arms), SCAR (Scarring/spots), HOT FLUSH (Hot flashes), CHILLS (Chills) and NAUSEA (Nausea) 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.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis/spots and scarring/psoriasis sploches on waist/torso/arms), SCAR (Scarring/spots), HOT FLUSH (Hot flashes), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, PSORIASIS (Psoriasis/spots and scarring/psoriasis sploches on waist/torso/arms) and SCAR (Scarring/spots) was resolving and HOT FLUSH (Hot flashes), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. The reporter's causality for the event(s) of chills, nausea and hot flashes with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of spots and scarring/psoriasis sploches onwaist/torso/arms unknown onset and spots and scarring/psoriasis sploches on waist/torso/arms unknown onset was  not provided. 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, UNK
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received 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 RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient experienced a runny nose and sore throat.  The reporters causality for the events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: M
Vaccine: COVID19
Symptoms: Acne, Pain in extremity, Rash erythematous
Clinical narrative: little pimples; Red rash; his arm kind of hurts; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (little pimples), RASH ERYTHEMATOUS (Red rash) and PAIN IN EXTREMITY (his arm kind of hurts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (little pimples), RASH ERYTHEMATOUS (Red rash) and PAIN IN EXTREMITY (his arm kind of hurts). At the time of the report, ACNE (little pimples), RASH ERYTHEMATOUS (Red rash) and PAIN IN EXTREMITY (his arm kind of hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Patient got Moderna Covid 19 vaccine a week ago, caller stated a few days ago he started to get type of rashes ,there are more like a little pimples but more red and they don't go away. Patient used creams and it's kind of going away but is really not doing anything. He also had arm pain sometimes.  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: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Systemic sclerosis, Scleroderma, Bronchiectasis, Hypogammaglobulinemia (low IGG to bind to primary antibodies), Chronic kidney disease stage 3 (50% Kidney function) and Heart disease, unspecified.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm) had resolved.            Concomitant products were not provided. Treatment medication were not reported.  Patient have a connective tissue disease, features of lupus.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Pyrexia, Vaccination site pain
Clinical narrative: Flare up of plaque psoriasis; First injection reaction was fever and sore; First injection reaction was fever and sore; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flare up of plaque psoriasis), PYREXIA (First injection reaction was fever and sore) and VACCINATION SITE PAIN (First injection reaction was fever and sore) in a 58-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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (First injection reaction was fever and sore) and VACCINATION SITE PAIN (First injection reaction was fever and sore). On an unknown date, the patient experienced PSORIASIS (Flare up of plaque psoriasis). At the time of the report, PSORIASIS (Flare up of plaque psoriasis) had not resolved and PYREXIA (First injection reaction was fever and sore) and VACCINATION SITE PAIN (First injection reaction was fever and sore) outcome was unknown.            No concomitant medications were reported. On an unknown date, the patient experienced flare up of Plaque psoriasis. In 2021, the patient experienced Moderna vaccination reaction/first injection reaction was fever and sore. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623160 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 58-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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported. In 2021, the patient experienced Moderna vaccination reaction/ second injection reaction was fatigue. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623158 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling worst/ Condition worst after having COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling worst/ Condition worst after having COVID vaccine) in a 19-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 an unknown indication.    No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FEELING ABNORMAL (Feeling worst/ Condition worst after having COVID vaccine). At the time of the report, FEELING ABNORMAL (Feeling worst/ Condition worst after having COVID vaccine) was resolving.            No concomitant medication provided. No treatment information mentioned.  In 2021, patient was feeling worse and felt worse after having COVID vaccine.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Knots on hands that cause pain) and PAIN IN EXTREMITY (Pain in arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received 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 NODULE (Knots on hands that cause pain) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, NODULE (Knots on hands that cause pain) had not resolved and PAIN IN EXTREMITY (Pain in arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. No treatment information mentioned. Patient experienced knots on hands that cause pain and pain in arm. On an unknown date, pain in arm was resolved. The reporters causality for event knots on hands with Humira was no reasonably possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (side effects). At the time of the report, IMMUNISATION REACTION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment drug was not 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: Body temperature, Fatigue, Myalgia
Clinical narrative: Muscle aches; Tired for a day or two/spent time in bed; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches) and FATIGUE (Tired for a day or two/spent time in bed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle aches) and FATIGUE (Tired for a day or two/spent time in bed). At the time of the report, MYALGIA (Muscle aches) and FATIGUE (Tired for a day or two/spent time in bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Slight elevated temperature.         Patient had bed bound, its not necessarily bed bound but tired for a day or two and spent some time in bed.  Concomitant product use was not provided by the reporter. 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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron, Dizziness, Head discomfort
Clinical narrative: weird feeling on head; lightheaded after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (weird feeling on head) and DIZZINESS (lightheaded after first shot) in a 25-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 Ulcerative colitis.    The patient's past medical history included Non-tobacco user and Alcohol use (ALCOHOL USER:BEER, WINE OR HARD LIQUOR BASED ON HIS MOOD). Concurrent medical conditions included Ulcerative colitis and Blood iron decreased. Concomitant products included IRON POLYMALETHER for Blood iron, MESALAMINE for Ulcerative colitis.   In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced HEAD DISCOMFORT (weird feeling on head). In 2021, the patient experienced DIZZINESS (lightheaded after first shot). On 27-May-2021, HEAD DISCOMFORT (weird feeling on head) had resolved. In 2021, DIZZINESS (lightheaded after first shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron: low.         In 2021 citrate free pen malfunction with Humira 40MG/0.4ML.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624152.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Patient age, medical history, laboratory data, concomitant medication and new event were added. Narrative updated.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysstasia, Pain
Clinical narrative: Pain aggravated; Difficulty in standing; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain aggravated), DYSSTASIA (Difficulty in standing) and DIARRHOEA (Diarrhea) in a 47-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.    No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form. In 2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced PAIN (Pain aggravated) and DYSSTASIA (Difficulty in standing). At the time of the report, PAIN (Pain aggravated) and DYSSTASIA (Difficulty in standing) had resolved and DIARRHOEA (Diarrhea) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed event of diarrhea as related to Moderna vaccine and did not provide any causality assessment for the rest of the events with Moderna vaccine.  The reporter did not provide any causality assessment for the event of difficulty in standing with Humira. The reporter assessed the event of pain aggravated as reasonably possible with Humira and event of diarrhea as not reasonably possible with Humira.  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: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blister, Body temperature, Body temperature increased, Condition aggravated, Cough
Clinical narrative: Condition aggravated; Blister; Cough; Ache; Sniffles; Body temperature increased; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), BLISTER (Blister), COUGH (Cough), PAIN (Ache) and RHINORRHOEA (Sniffles) in a 48-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 Plaque psoriasis and Hidradenitis suppurativa.    No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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) CF. In 2021, the patient experienced PAIN (Ache), RHINORRHOEA (Sniffles) and BODY TEMPERATURE INCREASED (Body temperature increased). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated), BLISTER (Blister) and COUGH (Cough). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), BLISTER (Blister) and COUGH (Cough) had not resolved and PAIN (Ache), RHINORRHOEA (Sniffles) and BODY TEMPERATURE INCREASED (Body temperature increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: Body temperature increased.         Concomitant drugs not reported. There was no reported medical history. For HUMIRA, the reporter causality for the events of Outbreaks and flare ups, Big lumps/could tell there was fluid on trunk and right breast and Cough was a reasonable possibility and the reporter causality for the events of Felt achy, Sniffles and patient had Mild temperature 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. Treatment drugs not reported.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Rhinorrhoea
Clinical narrative: Condition aggravated; Blister; Cough; Ache; Sniffles; Body temperature increased; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), BLISTER (Blister), COUGH (Cough), PAIN (Ache) and RHINORRHOEA (Sniffles) in a 48-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 Plaque psoriasis and Hidradenitis suppurativa.    No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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) CF. In 2021, the patient experienced PAIN (Ache), RHINORRHOEA (Sniffles) and BODY TEMPERATURE INCREASED (Body temperature increased). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated), BLISTER (Blister) and COUGH (Cough). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), BLISTER (Blister) and COUGH (Cough) had not resolved and PAIN (Ache), RHINORRHOEA (Sniffles) and BODY TEMPERATURE INCREASED (Body temperature increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: Body temperature increased.         Concomitant drugs not reported. There was no reported medical history. For HUMIRA, the reporter causality for the events of Outbreaks and flare ups, Big lumps/could tell there was fluid on trunk and right breast and Cough was a reasonable possibility and the reporter causality for the events of Felt achy, Sniffles and patient had Mild temperature 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. Treatment drugs not reported.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain, Pyrexia, Rash
Clinical narrative: Swelling; PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT; On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose; TIRED; PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT; HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE IRRITATION (HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE), SWELLING (Swelling), PAIN (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose) and FATIGUE (TIRED) in a 61-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 Plaque psoriasis and Rheumatoid arthritis.    No Medical History information was reported.   On 20-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. In 2021, the patient experienced VACCINATION SITE IRRITATION (HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE) and PYREXIA (Fever). On an unknown date, the patient experienced SWELLING (Swelling), PAIN (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose), FATIGUE (TIRED) and RASH (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT). In 2021, VACCINATION SITE IRRITATION (HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE) and PYREXIA (Fever) had resolved. At the time of the report, SWELLING (Swelling), PAIN (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose) and RASH (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT) outcome was unknown and FATIGUE (TIRED) had not resolved.            Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site irritation
Clinical narrative: Swelling; PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT; On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose; TIRED; PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT; HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE IRRITATION (HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE), SWELLING (Swelling), PAIN (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose) and FATIGUE (TIRED) in a 61-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 Plaque psoriasis and Rheumatoid arthritis.    No Medical History information was reported.   On 20-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. In 2021, the patient experienced VACCINATION SITE IRRITATION (HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE) and PYREXIA (Fever). On an unknown date, the patient experienced SWELLING (Swelling), PAIN (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose), FATIGUE (TIRED) and RASH (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT). In 2021, VACCINATION SITE IRRITATION (HAD MODERNA VACCINATION AND HAD IRRITATION AT INJECTION SITE) and PYREXIA (Fever) had resolved. At the time of the report, SWELLING (Swelling), PAIN (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 20 Apr 2021, patient received 1st dose, On 01 May 2021, patient received 2nd dose) and RASH (PAIN and A WEEK BEFORE HUMIRA INJECTION WAS DUE SKIN ON FACE STARTS TO BREAK OUT) outcome was unknown and FATIGUE (TIRED) had not resolved.            Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.