chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: Feeling not well; On 5 Aug 2021, he received 1st dose and On 13 Sep 2021, he received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling not well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 5 Aug 2021, he received 1st dose and On 13 Sep 2021, he received 2nd dose) 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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe ).   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Feeling not well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 5 Aug 2021, he received 1st dose and On 13 Sep 2021, he received 2nd dose). At the time of the report, MALAISE (Feeling not well) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 5 Aug 2021, he received 1st dose and On 13 Sep 2021, he received 2nd dose) outcome was unknown.            No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.  The reporter's causality for the event(s) of feeling not well with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Joint noise, Vaccination site rash
Clinical narrative: When walked knees snap; On 02 Jul 2021, received 1st dose COVID-19 Vaccine manufactured by Moderna. On 09 Aug 2021, received 2nd dose COVID-19 Vaccine; Rash around vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT NOISE (When walked knees snap), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 02 Jul 2021, received 1st dose COVID-19 Vaccine manufactured by Moderna. On 09 Aug 2021, received 2nd dose COVID-19 Vaccine) and VACCINATION SITE RASH (Rash around vaccine site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In 2021, the patient experienced VACCINATION SITE RASH (Rash around vaccine site). On 09-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 02 Jul 2021, received 1st dose COVID-19 Vaccine manufactured by Moderna. On 09 Aug 2021, received 2nd dose COVID-19 Vaccine). On an unknown date, the patient experienced JOINT NOISE (When walked knees snap). In 2021, VACCINATION SITE RASH (Rash around vaccine site) had resolved. At the time of the report, JOINT NOISE (When walked knees snap) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 02 Jul 2021, received 1st dose COVID-19 Vaccine manufactured by Moderna. On 09 Aug 2021, received 2nd dose COVID-19 Vaccine) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Influenza like illness
Clinical narrative: ANKYLOSING SPONDYLITIS FLARE UP; FLU LIKE SYMPTOMS FOR A COUPLE DAYS; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) in a 43-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 Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS FOR A COUPLE DAYS). At the time of the report, ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) had not resolved and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS FOR A COUPLE DAYS) 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.  Company comment: This spontaneous case concerns a 43-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) event of ankylosing spondylitis (AESI) an unknown time after the first, second and booster dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) event of ankylosing spondylitis (AESI) an unknown time after the first, second and booster dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Headache, Skin discolouration, Urticaria, Vision blurred
Clinical narrative: Hives for 4 months; headache; Blurry vision; Double vision; dark area off the right side peripherally; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (Blurry vision), DIPLOPIA (Double vision), SKIN DISCOLOURATION (dark area off the right side peripherally), URTICARIA (Hives for 4 months) and HEADACHE (headache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 028A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concomitant products included MODAFINIL for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-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 third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced VISION BLURRED (Blurry vision), DIPLOPIA (Double vision), SKIN DISCOLOURATION (dark area off the right side peripherally) and HEADACHE (headache). On an unknown date, the patient experienced URTICARIA (Hives for 4 months). At the time of the report, VISION BLURRED (Blurry vision), DIPLOPIA (Double vision), SKIN DISCOLOURATION (dark area off the right side peripherally), URTICARIA (Hives for 4 months) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication 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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Finger deformity, Oral herpes
Clinical narrative: right hand fingers were a bit deformed; Tiredness; Cold sores; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores), FINGER DEFORMITY (right hand fingers were a bit deformed) and FATIGUE (Tiredness) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis, Plaque psoriasis and Ulcerative colitis.    No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced ORAL HERPES (Cold sores). On an unknown date, the patient experienced FINGER DEFORMITY (right hand fingers were a bit deformed) and FATIGUE (Tiredness). At the time of the report, ORAL HERPES (Cold sores) outcome was unknown and FINGER DEFORMITY (right hand fingers were a bit deformed) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in covid-19 vaccine trials.  No concomitant product reported by reporter.  As of 18-Jan-2022, patient was concerned about his finger deformity.  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.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Live significant follow-up included updated patient age, action taken with the suspect product and event outcome.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cystitis, Fatigue, Hepatic enzyme increased, Liver function test, Muscle spasms
Clinical narrative: Sinus infection; Elevated liver enzymes/high liver enzymes; Leg cramps after COVID vaccine; Fatigue/really tired; Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection), SINUSITIS (Sinus infection), HEPATIC ENZYME INCREASED (Elevated liver enzymes/high liver enzymes), MUSCLE SPASMS (Leg cramps after COVID vaccine) and FATIGUE (Fatigue/really tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. In March 2021, the patient experienced CYSTITIS (Bladder infection). On an unknown date, the patient experienced SINUSITIS (Sinus infection), HEPATIC ENZYME INCREASED (Elevated liver enzymes/high liver enzymes), MUSCLE SPASMS (Leg cramps after COVID vaccine) and FATIGUE (Fatigue/really tired). At the time of the report, CYSTITIS (Bladder infection) had not resolved and SINUSITIS (Sinus infection), HEPATIC ENZYME INCREASED (Elevated liver enzymes/high liver enzymes), MUSCLE SPASMS (Leg cramps after COVID vaccine) and FATIGUE (Fatigue/really tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: High.         Concomitant product information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of fatigue/really tired, bladder infection, high liver enzymes, leg cramps after COVID vaccine and sinus infection with Humira(adalimumab) was no reasonable possibility. 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: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sinusitis
Clinical narrative: Sinus infection; Elevated liver enzymes/high liver enzymes; Leg cramps after COVID vaccine; Fatigue/really tired; Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection), SINUSITIS (Sinus infection), HEPATIC ENZYME INCREASED (Elevated liver enzymes/high liver enzymes), MUSCLE SPASMS (Leg cramps after COVID vaccine) and FATIGUE (Fatigue/really tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. In March 2021, the patient experienced CYSTITIS (Bladder infection). On an unknown date, the patient experienced SINUSITIS (Sinus infection), HEPATIC ENZYME INCREASED (Elevated liver enzymes/high liver enzymes), MUSCLE SPASMS (Leg cramps after COVID vaccine) and FATIGUE (Fatigue/really tired). At the time of the report, CYSTITIS (Bladder infection) had not resolved and SINUSITIS (Sinus infection), HEPATIC ENZYME INCREASED (Elevated liver enzymes/high liver enzymes), MUSCLE SPASMS (Leg cramps after COVID vaccine) and FATIGUE (Fatigue/really tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: High.         Concomitant product information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of fatigue/really tired, bladder infection, high liver enzymes, leg cramps after COVID vaccine and sinus infection with Humira(adalimumab) was no reasonable possibility. 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: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Blood test, Fatigue, Headache
Clinical narrative: BACK PAIN; HAND PAIN; KNEE PAIN/WRIST PAIN; COVID VACCINES CAUSED HEADACHE; TIREDNESS; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (BACK PAIN), PAIN IN EXTREMITY (HAND PAIN), ARTHRALGIA (KNEE PAIN/WRIST PAIN), HEADACHE (COVID VACCINES CAUSED HEADACHE) and FATIGUE (TIREDNESS) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   In August 2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received third 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced BACK PAIN (BACK PAIN), PAIN IN EXTREMITY (HAND PAIN), ARTHRALGIA (KNEE PAIN/WRIST PAIN), HEADACHE (COVID VACCINES CAUSED HEADACHE) and FATIGUE (TIREDNESS). At the time of the report, BACK PAIN (BACK PAIN), HEADACHE (COVID VACCINES CAUSED HEADACHE) and FATIGUE (TIREDNESS) outcome was unknown and PAIN IN EXTREMITY (HAND PAIN) and ARTHRALGIA (KNEE PAIN/WRIST PAIN) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal.  Concomitant product use was not provided by the reporter.  In Aug 2021, patient switched from Humira to Rinvoq and was still experiencing pain in one knee as well as new pain in the wrist and hand since beginning Rinvoq. Covid vaccines caused headache and tiredness. She mentioned she had back pain and knee pain in joints.  Blood work had been normal since being on Rinvoq.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of knee pain/wrist pain and hand pain with Rinvoq (Upadacitinib) was a reasonable possibility.  The reporter's causality for the events of covid vaccines caused headache and tiredness unknown onset, covid vaccines caused headache and tiredness unknown onset and back pain with Rinvoq (Upadacitinib) was no reasonable possibility.  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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Live follow-up information received included added event of Back Pain and suspect product dosage information updated.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: BACK PAIN; HAND PAIN; KNEE PAIN/WRIST PAIN; COVID VACCINES CAUSED HEADACHE; TIREDNESS; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (BACK PAIN), PAIN IN EXTREMITY (HAND PAIN), ARTHRALGIA (KNEE PAIN/WRIST PAIN), HEADACHE (COVID VACCINES CAUSED HEADACHE) and FATIGUE (TIREDNESS) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   In August 2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received third 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced BACK PAIN (BACK PAIN), PAIN IN EXTREMITY (HAND PAIN), ARTHRALGIA (KNEE PAIN/WRIST PAIN), HEADACHE (COVID VACCINES CAUSED HEADACHE) and FATIGUE (TIREDNESS). At the time of the report, BACK PAIN (BACK PAIN), HEADACHE (COVID VACCINES CAUSED HEADACHE) and FATIGUE (TIREDNESS) outcome was unknown and PAIN IN EXTREMITY (HAND PAIN) and ARTHRALGIA (KNEE PAIN/WRIST PAIN) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal.  Concomitant product use was not provided by the reporter.  In Aug 2021, patient switched from Humira to Rinvoq and was still experiencing pain in one knee as well as new pain in the wrist and hand since beginning Rinvoq. Covid vaccines caused headache and tiredness. She mentioned she had back pain and knee pain in joints.  Blood work had been normal since being on Rinvoq.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of knee pain/wrist pain and hand pain with Rinvoq (Upadacitinib) was a reasonable possibility.  The reporter's causality for the events of covid vaccines caused headache and tiredness unknown onset, covid vaccines caused headache and tiredness unknown onset and back pain with Rinvoq (Upadacitinib) was no reasonable possibility.  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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Live follow-up information received included added event of Back Pain and suspect product dosage information updated.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: outbreaks/psoriasis patient experiencing bad breakthrough/broke out; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (outbreaks/psoriasis patient experiencing bad breakthrough/broke out) 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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On an unknown date, the patient experienced PSORIASIS (outbreaks/psoriasis patient experiencing bad breakthrough/broke out). At the time of the report, PSORIASIS (outbreaks/psoriasis patient experiencing bad breakthrough/broke out) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in covid-19 vaccine trials.  No concomitant product reported by reporter.  The reporter's causality for the event(s) of outbreaks/psoriasis patient experiencing bad breakthrough/broke out with humira 40mg/0.4ml(adalimumab) was a reasonable possibility.  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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Significant live follow-up information included updated event information.
Age: 52.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Ache; Fever; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) in a 52-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 Ankylosing spondylitis and Attention deficit hyperactivity disorder.    Concurrent medical conditions included Ankylosing spondylitis and Attention deficit hyperactivity disorder.   On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Ache) and PYREXIA (Fever). On 19-Nov-2021, PAIN (Ache), PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  It was reported that on an unknown date patient experienced drug use for unapproved indication (Humira for attention deficit hyperactivity).  The reporter's causality for the event(s) of PATIENT WAS TAKING HUMIRA FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER was not provided. The reporter's causality for the event(s) of ARM FELT ACHEY, FEVERISH ACHEY FEELING onset 18 Nov 2021 and FEVERISH ACHEY FEELING onset 18 Nov 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Weight decreased
Clinical narrative: weight loss; has also been nauseous ever since; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (weight loss) and NAUSEA (has also been nauseous ever since) in a 79-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced WEIGHT DECREASED (weight loss) and NAUSEA (has also been nauseous ever since). At the time of the report, WEIGHT DECREASED (weight loss) and NAUSEA (has also been nauseous ever since) 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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Live significant FU appended: patient age, dosing regimen.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Skin disorder
Clinical narrative: Skin disorder; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Skin disorder) and FATIGUE (Tiredness) 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 Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate To Severe Chronic Plaque Psoriasis).   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 SKIN DISORDER (Skin disorder) and FATIGUE (Tiredness). At the time of the report, SKIN DISORDER (Skin disorder) was resolving and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had spots on elbow or some spots and tired.  The reporter's causality for the events of Skin disorder and Tiredness was reported as No reasonable possibility for Humira.  No treatment medication were 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: Chills, Hyperhidrosis, Mobility decreased, Pyrexia
Clinical narrative: Could not get up and down stairs; Sweats after covid vaccine; Chills after covid vaccination; Fever after covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not get up and down stairs), HYPERHIDROSIS (Sweats after covid vaccine), CHILLS (Chills after covid vaccination) and PYREXIA (Fever after covid vaccination) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Knee pain.   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 MOBILITY DECREASED (Could not get up and down stairs), HYPERHIDROSIS (Sweats after covid vaccine), CHILLS (Chills after covid vaccination) and PYREXIA (Fever after covid vaccination). At the time of the report, MOBILITY DECREASED (Could not get up and down stairs), HYPERHIDROSIS (Sweats after covid vaccine), CHILLS (Chills after covid vaccination) and PYREXIA (Fever after covid vaccination) 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. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of COULD NOT GET UP AND DOWN STAIRS, SWEATS AFTER COVID VACCINE, CHILLS AFTER COVID VACCINATION and FEVER AFTER COVID VACCINATION with HUMIRA(ADALIMUMAB) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 50.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Cystitis, Hand deformity, Vaccination site swelling
Clinical narrative: Hand deformity; Bladder infection; SWELLING AT INJECTION SITE AFTER COVID-19 VACCINATION SHOT; This spontaneous case was reported by a consumer and describes the occurrence of HAND DEFORMITY (Hand deformity), CYSTITIS (Bladder infection) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE AFTER COVID-19 VACCINATION SHOT) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Bladder operation in 2020. Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE AFTER COVID-19 VACCINATION SHOT). In August 2021, the patient experienced CYSTITIS (Bladder infection). On an unknown date, the patient experienced HAND DEFORMITY (Hand deformity). At the time of the report, HAND DEFORMITY (Hand deformity) had not resolved and CYSTITIS (Bladder infection) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE AFTER COVID-19 VACCINATION SHOT) had resolved.            No Concomitant medication were reported.  There was no reported medical history.  The reporter's causality for the event(s) of Bladder surgery and Bladder infection with Humira was no reasonable possibility. The reporter's causality for the event(s) of Hands deformity with HUMIRA was a reasonable possibility. The reporter's causality for the event(s) of Swelling at injection site after Covid-19 Vaccination shot was not provided.  No Treatment medication were reported.   This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in
Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Nerve compression, Pyrexia, Spinal pain
Clinical narrative: Went to pain management to spine due to pinched nerves; Went to pain management to spine due to pinched nerves; Had fever for first COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (Went to pain management to spine due to pinched nerves), SPINAL PAIN (Went to pain management to spine due to pinched nerves) and PYREXIA (Had fever for first COVID 19 vaccine) in a 61-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 and Psoriatic arthritis.    No Medical History information was reported.   On 04-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. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 04-Mar-2021, the patient experienced PYREXIA (Had fever for first COVID 19 vaccine). On an unknown date, the patient experienced NERVE COMPRESSION (Went to pain management to spine due to pinched nerves) and SPINAL PAIN (Went to pain management to spine due to pinched nerves). In March 2021, PYREXIA (Had fever for first COVID 19 vaccine) had resolved. At the time of the report, NERVE COMPRESSION (Went to pain management to spine due to pinched nerves) and SPINAL PAIN (Went to pain management to spine due to pinched nerves) had resolved.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: her arm broke out with big red things; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (her arm broke out with big red things) in a female 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 RASH ERYTHEMATOUS (her arm broke out with big red things). At the time of the report, RASH ERYTHEMATOUS (her arm broke out with big red things) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Live Follow-up
Age: 21.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Gastric infection, SARS-CoV-2 test
Clinical narrative: Stomach bug; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC INFECTION (Stomach bug) in a 21-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced GASTRIC INFECTION (Stomach bug). At the time of the report, GASTRIC INFECTION (Stomach bug) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  In 2021, patient got a positive COVID-19 test. In DEC of 2021, got the stomach bug.  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, COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. Patient took first shot of Pfizer, second shot of moderna and booster shot of Janssen. 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: Fatigue, Rash
Clinical narrative: break outs under arm area/flare up; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (break outs under arm area/flare up) and FATIGUE (Fatigue) in a 48-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 and Rheumatoid arthritis.    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 10-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 RASH (break outs under arm area/flare up) and FATIGUE (Fatigue). At the time of the report, RASH (break outs under arm area/flare up) had not resolved and FATIGUE (Fatigue) 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.
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) in a 54-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 Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Nov-2021, the patient experienced CHILLS (CHILLS). At the time of the report, CHILLS (CHILLS) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment drug was provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Increased joint pain and stiffness; Increased joint pain and stiffness; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Increased joint pain and stiffness) and ARTHRALGIA (Increased joint pain and stiffness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-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) 40 milligram. On 26-Nov-2021, the patient experienced JOINT STIFFNESS (Increased joint pain and stiffness) and ARTHRALGIA (Increased joint pain and stiffness). At the time of the report, JOINT STIFFNESS (Increased joint pain and stiffness) and ARTHRALGIA (Increased joint pain and stiffness) was resolving.            No concomitant medication provided. No treatment information mentioned.  Patient had increased joint pain and stiffness ever since taking Moderna booster.  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   This case was linked to MOD-2022-569498 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in 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 Crohn's disease and Crohn's disease.    No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.     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.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hyperhidrosis, Muscle spasms
Clinical narrative: Muscle spasms; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and MUSCLE SPASMS (Muscle spasms) in a 70-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 Rheumatoid arthritis.    Concomitant products included CHOLESTEROL for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-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) (Subcutaneous) at an unspecified dose. On 29-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasms). At the time of the report, HYPERHIDROSIS (Sweating) had resolved and MUSCLE SPASMS (Muscle spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with Muscle Relaxant.  No Treatment Drug 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: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain
Clinical narrative: Ache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache) and FATIGUE (Tiredness) in a 48-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 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. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced PAIN (Ache) and FATIGUE (Tiredness). In 2021, PAIN (Ache) and FATIGUE (Tiredness) had resolved.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.