chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache
Clinical narrative: DULL HEADACHE BEHIND THE RIGHT EYE; FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP) and HEADACHE (DULL HEADACHE BEHIND THE RIGHT EYE) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, Ankylosing spondylitis and Ulcerative colitis.    No Medical History information was reported.   On 01-Mar-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. In November 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. In November 2021, the patient experienced CONDITION AGGRAVATED (FLARE UP). On an unknown date, the patient experienced HEADACHE (DULL HEADACHE BEHIND THE RIGHT EYE). In 2021, CONDITION AGGRAVATED (FLARE UP) had resolved. At the time of the report, HEADACHE (DULL HEADACHE BEHIND THE RIGHT EYE) had resolved.            Concomitant medication was not reported.  In Nov-2021, patient experienced flare up of condition. On an unknown date, patient experienced dull headache behind right eye. On 31-Jul-2021, patient again experienced dull headache behind right eye. 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.   This case was linked to MOD-2021-623627.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin breaking out; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin breaking out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 22-Jan-2021, 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) 1 dosage form. On an unknown date, the patient experienced RASH (Skin breaking out). At the time of the report, RASH (Skin breaking out) was resolving.            No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Vaccination site pain/ sore arm from covid-19 booster; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain/ sore arm from covid-19 booster) and FATIGUE (Fatigue) in a 34-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.    Previously administered products included for COVID-19 vaccination: COVID-19 Vaccine by  and Johnson (1st dose, intramuscular) on 06-Apr-2021, COVID-19 Vaccine by  and Johnson (2nd dose and intramuscular) in 2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine by  and Johnson and COVID-19 Vaccine by  and Johnson. Concurrent medical conditions included Crohn's disease.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/ sore arm from covid-19 booster) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain/ sore arm from covid-19 booster) and FATIGUE (Fatigue) was resolving. Not Provided          No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  On an unknown date biopsy and colonoscopy were performed, results not obtained.  The reporter's causality for the event(s) of SORE ARM FROM COVID-19 BOOSTER with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of FATIGUED FROM COVID-19 BOOSTER with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment medication 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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Live-Significant Follow up- Administration route and indication for medical historical vaccine, Moderna vaccine start date, HUMIRA drug lot number were updated and lab data and procedure information were added to inarrative supplement.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Inappropriate schedule of product administration, Intentional product misuse, No adverse event
Clinical narrative: PATIENT SKIPPED DOSE OF HUMIRA BECAUSE OF COVID EXPOSURE; PATIENT SKIPPED DOSE OF HUMIRA BECAUSE OF COVID EXPOSURE; Inappropriate schedule of vaccine administered; No Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT MISUSE (PATIENT SKIPPED DOSE OF HUMIRA BECAUSE OF COVID EXPOSURE), EXPOSURE TO SARS-COV-2 (PATIENT SKIPPED DOSE OF HUMIRA BECAUSE OF COVID EXPOSURE), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse Event) 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 an unknown indication.    No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INTENTIONAL PRODUCT MISUSE (PATIENT SKIPPED DOSE OF HUMIRA BECAUSE OF COVID EXPOSURE), EXPOSURE TO SARS-COV-2 (PATIENT SKIPPED DOSE OF HUMIRA BECAUSE OF COVID EXPOSURE), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, INTENTIONAL PRODUCT MISUSE (PATIENT SKIPPED DOSE OF HUMIRA BECAUSE OF COVID EXPOSURE) and EXPOSURE TO SARS-COV-2 (PATIENT SKIPPED DOSE OF HUMIRA BECAUSE OF COVID EXPOSURE) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse Event) 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.  No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pruritus
Clinical narrative: itchy; FEELING UNWELL; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (FEELING UNWELL) and PRURITUS (itchy) in a 62-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 Rheumatoid arthritis.    No Medical History information was reported.   On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 28-Aug-2021, the patient experienced MALAISE (FEELING UNWELL). On 30-Aug-2021, the patient experienced PRURITUS (itchy). In 2021, PRURITUS (itchy) had resolved. On 28-Aug-2021, MALAISE (FEELING UNWELL) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported.  The reporter's causality for the event(s) of did not feel well and breakout on the anterior arms skin, inside of the muscle that was itchy with Humira(adalimumab) was no reasonable possibility.  Treatment Drugs 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
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort
Clinical narrative: Stomach upset; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.  No Medical History information was reported.  On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-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-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset) outcome was unknown.  On 06-Jan-2021, the patient experienced stomach upset. On 03-Feb-2021, the patient experienced took covid-19 booster and wanted to sleep all day. On 25-aug-2021, the patient experienced took covid-19 booster and felt under the weather and took covid-19 booster and felt achy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624135, MOD-2021-624136 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Wanted to sleep all day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Wanted to sleep all day) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Feb-2021, the patient experienced SOMNOLENCE (Wanted to sleep all day). At the time of the report, SOMNOLENCE (Wanted to sleep all day) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SOMNOLENCE (Wanted to sleep all day) to be related.    No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624127, MOD-2021-624136 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: took covid-19 booster and felt under the weather and took covid-19 booster and felt achy; took covid-19 booster and felt under the weather and took covid-19 booster and felt achy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) and PAIN (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-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 25-Aug-2021, the patient experienced MALAISE (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) and PAIN (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy). At the time of the report, MALAISE (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) and PAIN (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) outcome was unknown.            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.   This case was linked to MOD-2021-624135, MOD-2021-624127.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Haemoglobin, Headache, Oxygen saturation
Clinical narrative: Weakness; Asthenia; Chills; headache; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (Weakness), ASTHENIA (Asthenia), CHILLS (Chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) injection for Atopic dermatitis and CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication.    The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Rash and Atopic dermatitis. Concomitant products included USTEKINUMAB (STELARA) for an unknown indication.   On 04-Feb-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 18-Feb-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram once a week. In April 2021, the patient started CERTOLIZUMAB PEGOL (CIMZIA) (unknown route) at an unspecified dose. On 17-Aug-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram once a week. In August 2021, the patient experienced TREMOR (Shaking). On 30-Aug-2021, the patient experienced ASTHENIA (Weakness), ASTHENIA (Asthenia), CHILLS (Chills) and HEADACHE (headache). At the time of the report, TREMOR (Shaking), ASTHENIA (Weakness), ASTHENIA (Asthenia), CHILLS (Chills) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: hemoglobin dropped from 13 to 8.. On an unknown date, Oxygen saturation: Remain stable.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized for Lupus-like syndrome, Haemolytic anaemia, Renal failure, Pulmonary oedema, Angioedema and hospitalization for Haemoglobin decreased experienced prior to moderna vaccine. Pulmonary oedema was treated with Furosemide.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Weakness; Asthenia; Chills; headache; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (Weakness), ASTHENIA (Asthenia), CHILLS (Chills) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) injection for Atopic dermatitis and CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication.    The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Rash and Atopic dermatitis. Concomitant products included USTEKINUMAB (STELARA) for an unknown indication.   On 04-Feb-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 18-Feb-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram once a week. In April 2021, the patient started CERTOLIZUMAB PEGOL (CIMZIA) (unknown route) at an unspecified dose. On 17-Aug-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram once a week. In August 2021, the patient experienced TREMOR (Shaking). On 30-Aug-2021, the patient experienced ASTHENIA (Weakness), ASTHENIA (Asthenia), CHILLS (Chills) and HEADACHE (headache). At the time of the report, TREMOR (Shaking), ASTHENIA (Weakness), ASTHENIA (Asthenia), CHILLS (Chills) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: hemoglobin dropped from 13 to 8.. On an unknown date, Oxygen saturation: Remain stable.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized for Lupus-like syndrome, Haemolytic anaemia, Renal failure, Pulmonary oedema, Angioedema and hospitalization for Haemoglobin decreased experienced prior to moderna vaccine. Pulmonary oedema was treated with Furosemide.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Fatigued/tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued/tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigued/tired). At the time of the report, FATIGUE (Fatigued/tired) outcome was unknown.            No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Wheelchair user
Clinical narrative: Patient was 6 weeks out and was still in a wheelchair; Long term muscle weakness; Experienced pain going down to the front of legs; This spontaneous case was reported by a physician and describes the occurrence of WHEELCHAIR USER (Patient was 6 weeks out and was still in a wheelchair), MUSCULAR WEAKNESS (Long term muscle weakness) and PAIN IN EXTREMITY (Experienced pain going down to the front of legs) in an 80-year-old female patient 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 WHEELCHAIR USER (Patient was 6 weeks out and was still in a wheelchair), MUSCULAR WEAKNESS (Long term muscle weakness) and PAIN IN EXTREMITY (Experienced pain going down to the front of legs). At the time of the report, WHEELCHAIR USER (Patient was 6 weeks out and was still in a wheelchair) had not resolved and MUSCULAR WEAKNESS (Long term muscle weakness) and PAIN IN EXTREMITY (Experienced pain going down to the front of legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient was not having funny sensations and the weakness in muscles was not just for 2-3 days but even after 6 weeks later patient had to go on a wheelchair because the legs were so weak. The patient was walking before, and it was not just muscle pain.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-624196, US-MODERNATX, INC.-MOD-2021-624209 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-624196: US-MODERNATX, INC.-MOD-2021-624209:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tired, achy & feverish; Achy & feverish; Feverish; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FATIGUE (Tired, achy & feverish), PAIN (Achy & feverish) and PYREXIA (Feverish) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 11-Sep-2020 and PFIZER BIONTECH COVID-19 VACCINE on 02-Oct-2020. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced FATIGUE (Tired, achy & feverish), PAIN (Achy & feverish) and PYREXIA (Feverish). At the time of the report, COVID-19 (COVID-19), FATIGUE (Tired, achy & feverish), PAIN (Achy & feverish) and PYREXIA (Feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. It was reported that patient had decided to withdraw from pfizerinc COVID clinical trial. It was reported that patient had stopped using inhale two weeks ago as the cough was finally gone with which patient was suffering. 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.   Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Pain
Clinical narrative: lot of pain; joint swelling worse; joint pain worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lot of pain), JOINT SWELLING (joint swelling worse) and ARTHRALGIA (joint pain worse) 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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe rheumatoid arthritis). Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced JOINT SWELLING (joint swelling worse) and ARTHRALGIA (joint pain worse). On an unknown date, the patient experienced PAIN (lot of pain). At the time of the report, PAIN (lot of pain) outcome was unknown and JOINT SWELLING (joint swelling worse) and ARTHRALGIA (joint pain worse) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Information received on 30 Mar 2022: It was determined that this case was considered a duplicate of AER 22K-163-4340390-00. All information from both cases were merged into this case and retained. AER 22K-163-4340390-00 was invalidated. 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Concomitant medication and current condition added. Pain added as new event.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Stress at work
Clinical narrative: Stress at work; Hidradenitis suppurativa flare ups; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Hidradenitis suppurativa flare ups) and STRESS AT WORK (Stress at work) in a 32-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 Hidradenitis suppurativa.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in pre-filled pen. In August 2021, the patient experienced CONDITION AGGRAVATED (Hidradenitis suppurativa flare ups). On an unknown date, the patient experienced STRESS AT WORK (Stress at work). At the time of the report, CONDITION AGGRAVATED (Hidradenitis suppurativa flare ups) and STRESS AT WORK (Stress at work) outcome was unknown.            The concomitant medication was not reported by reporter. On an unknown date, the patient experienced work-related stress. In Aug-2021, the patient experienced hidradenitis suppurativa flare ups after second dose of covid vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The treatment medication was not reported by reporter.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose on 27-MAY-2021 and 2nd dose on 11-JUN-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-MAY-2021 and 2nd dose on 11-JUN-2021) and NO ADVERSE EVENT (No adverse event) 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 Iron low. Concurrent medical conditions included Non-tobacco user and Alcohol use (Beer, wine or hard liquor based on his mood). Concomitant products included MESALAMINE for an unknown indication.   In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. 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 11-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-MAY-2021 and 2nd dose on 11-JUN-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-MAY-2021 and 2nd dose on 11-JUN-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            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.   This case was linked to MOD-2021-623173 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Super High Fever on Sunday; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Super High Fever on Sunday) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE in March 2021 and PFIZER BIONTECH COVID-19 VACCINE in April 2021. Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PYREXIA (Super High Fever on Sunday). In 2021, PYREXIA (Super High Fever on Sunday) had resolved. Not Provided          No information on concomitant medication were reported. It was reported that patient had super high fever on Sunday and completely back to the normal on Monday. And stated it was worth. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Blood test, COVID-19, Decreased appetite, Fatigue
Clinical narrative: Decreased appetite (using slim fast); Feeling not like myself; Hair thinnning; Increased tiredness; COVID infection (delta variant); This spontaneous case was reported by an other health care professional and describes the occurrence of DECREASED APPETITE (Decreased appetite (using slim fast)), FEELING ABNORMAL (Feeling not like myself), ALOPECIA (Hair thinnning), FATIGUE (Increased tiredness) and COVID-19 (COVID infection (delta variant)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) tablet for Breast cancer.    No Medical History information was reported.   On 29-May-2021, the patient started PALBOCICLIB (IBRANCE) (Oral) 100 milligram once a day. In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, 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 DECREASED APPETITE (Decreased appetite (using slim fast)), FEELING ABNORMAL (Feeling not like myself), ALOPECIA (Hair thinnning), FATIGUE (Increased tiredness) and COVID-19 (COVID infection (delta variant)). The patient was treated with FULVESTRANT (FASLODEX) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Decreased appetite (using slim fast)), FEELING ABNORMAL (Feeling not like myself), FATIGUE (Increased tiredness) and COVID-19 (COVID infection (delta variant)) outcome was unknown and ALOPECIA (Hair thinnning) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work looked good.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The patient experienced some symptoms of COVID-19 as runny nose (clear mucous), cough, sneezing. It was reported that for those symptoms ordered unspecified injections to help with recovery.  The patient was reported that throat congestion and cough had improved, but occurring only occasionally.  The reporter denied any missed dose.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Decreased appetite (using slim fast); Feeling not like myself; Hair thinnning; Increased tiredness; COVID infection (delta variant); This spontaneous case was reported by an other health care professional and describes the occurrence of DECREASED APPETITE (Decreased appetite (using slim fast)), FEELING ABNORMAL (Feeling not like myself), ALOPECIA (Hair thinnning), FATIGUE (Increased tiredness) and COVID-19 (COVID infection (delta variant)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) tablet for Breast cancer.    No Medical History information was reported.   On 29-May-2021, the patient started PALBOCICLIB (IBRANCE) (Oral) 100 milligram once a day. In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, 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 DECREASED APPETITE (Decreased appetite (using slim fast)), FEELING ABNORMAL (Feeling not like myself), ALOPECIA (Hair thinnning), FATIGUE (Increased tiredness) and COVID-19 (COVID infection (delta variant)). The patient was treated with FULVESTRANT (FASLODEX) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Decreased appetite (using slim fast)), FEELING ABNORMAL (Feeling not like myself), FATIGUE (Increased tiredness) and COVID-19 (COVID infection (delta variant)) outcome was unknown and ALOPECIA (Hair thinnning) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work looked good.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The patient experienced some symptoms of COVID-19 as runny nose (clear mucous), cough, sneezing. It was reported that for those symptoms ordered unspecified injections to help with recovery.  The patient was reported that throat congestion and cough had improved, but occurring only occasionally.  The reporter denied any missed dose.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PLAQUE PSORIASIS FLARE UP/SKIN BROKE OUT WITH PSORIASIS; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS FLARE UP/SKIN BROKE OUT WITH PSORIASIS) in a 53-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 Plaque psoriasis.    NO KNOWN ALLERGIES.  Concurrent medical conditions included Plaque psoriasis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced PSORIASIS (PLAQUE PSORIASIS FLARE UP/SKIN BROKE OUT WITH PSORIASIS). At the time of the report, PSORIASIS (PLAQUE PSORIASIS FLARE UP/SKIN BROKE OUT WITH PSORIASIS) had resolved.            No relevant concomitant medications were reported.  The reporter's causality for the event of plaque psoriasis flare up/skin broke out with psoriasis with humira(adalimumab) was a reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.   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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Significant follow up received included event verbatim updated, narrative updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergy to vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concurrent medical conditions included Plaque psoriasis.   On 14-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Oral) 1 dosage form. In 2021, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine). At the time of the report, ALLERGY TO VACCINE (Allergy to vaccine) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   The concomitant medication was not reported.  The reporter causality for the events with respect to Skyrizi was provided as not reported.  The treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Exhaustion; Pain in arm/Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Pain in arm/Sore 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) solution for injection 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) Citrate free. On an unknown date, the patient experienced FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Pain in arm/Sore arm). At the time of the report, FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Pain in arm/Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that on unknown dates, the patient experienced Exhausted and Sore arm. 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: 57.0
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 a 57-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 and Ankylosing spondylitis.    No Medical History information was reported.   On 16-Nov-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) was resolving.            The concomitant medication was not reported by reporter. On 06-Aug-2021, the patient experienced psoriasis flare after first covid vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The treatment medication was not reported by reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (Got sick) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product MACITENTAN tablet for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included RIOCIGUAT (ADEMPAS) and WARFARIN SODIUM (COUMADIN) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and MACITENTAN (Oral) 10 milligram once a day. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.  The patient got sick after Moderna booster shot and developed the same event after second dose.  The treatment medication was not provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: Immunodeficiency; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunodeficiency) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis.    Concurrent medical conditions included Hidradenitis (MODERATE TO SEVERE).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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) UNK,Solution for injection in pre-filled pen. In 2021, the patient experienced IMMUNODEFICIENCY (Immunodeficiency) (seriousness criterion medically significant). In 2021, IMMUNODEFICIENCY (Immunodeficiency) had resolved.            No concomitant medication information was provided. 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. No treatment medication was provided.  Company comment-This spontaneous case concerns a male patient aged 32 years with no relevant medical history reported, who experienced the unexpected serious (medically significant ) event of Immunodeficiency that occurred on an unknown date in 2021 in the context of mRNA-1273 vaccination. Patient had received 1st and 2nd dose of vaccination at an interval of 28 days in 2021. No further information on risk factors, clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 32 years with no relevant medical history reported, who experienced the unexpected serious (medically significant ) event of Immunodeficiency that occurred on an unknown date in 2021 in the context of mRNA-1273 vaccination. Patient had received 1st and 2nd dose of vaccination at an interval of 28 days in 2021. No further information on risk factors, clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral coldness
Clinical narrative: Cold fingers/toes; feeling achy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Cold fingers/toes) and PAIN (feeling achy) 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 Crohn's disease. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PERIPHERAL COLDNESS (Cold fingers/toes) and PAIN (feeling achy). At the time of the report, PERIPHERAL COLDNESS (Cold fingers/toes) and PAIN (feeling achy) had resolved.            The concomitant medication was not reported by reporter. On unknown dates, the patient experienced Cold fingers/toes and feeling achy.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.