chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Vaccination site pain
Clinical narrative: Arthritis; Site of vaccination painful; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis) and VACCINATION SITE PAIN (Site of vaccination painful) in a 68-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).   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Site of vaccination painful). On an unknown date, the patient experienced ARTHRITIS (Arthritis). At the time of the report, ARTHRITIS (Arthritis) had not resolved and VACCINATION SITE PAIN (Site of vaccination painful) had resolved.            There was no reported medical history.  Concomitant medications details were not reported.  On an unknown date, the patient had arthritis which was bad in knees. In 2021,the patient had sore arm.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of Arthritis and Site of vaccination painful was not provided for Rinvoq.  No treatment 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Joint stiffness, Musculoskeletal stiffness, Psoriasis
Clinical narrative: Early morning stiffness; Early morning joint stiffness; Feeling hot; Fatigue; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up), MUSCULOSKELETAL STIFFNESS (Early morning stiffness), JOINT STIFFNESS (Early morning joint stiffness), FEELING HOT (Feeling hot) and FATIGUE (Fatigue) in a 79-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 Plaque psoriasis.    No Medical History information was reported.   On 26-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 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. 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 November 2021, the patient experienced PSORIASIS (Psoriasis flare-up). On 07-Dec-2021, the patient experienced FEELING HOT (Feeling hot) and FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and JOINT STIFFNESS (Early morning joint stiffness). In 2021, PSORIASIS (Psoriasis flare-up) had resolved. On 11-Dec-2021, FEELING HOT (Feeling hot) and FATIGUE (Fatigue) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and JOINT STIFFNESS (Early morning joint stiffness) outcome was unknown. Not Provided          Causality for HUMIRA(ADALIMUMAB) Solution for injection in pre-filled: The reporter's causality for the event(s) of PSORIASIS BREAKOUT/IN HEAD/SMALL OF BACK AND ARMS, PSORIASIS. BREAKOUT, STIFFNESS IN HANDS AND JOINTS IN MORNING unknown onset, STIFFNESS IN HANDS AND JOINTS IN MORNING. unknown onset, AFTER THIRD COVID-19 VACCINE FATIGUED and AFTER THIRD COVID-19 VACCINE HOT was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No information on concomitant medication were reported. 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: M
Vaccine: COVID19
Symptoms: Psoriasis, Vaccination site pain
Clinical narrative: psoriasis flare up (psoriasis spot on arms and leg); covid vaccine issue like injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis flare up (psoriasis spot on arms and leg)) and VACCINATION SITE PAIN (covid vaccine issue like injection site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (psoriasis flare up (psoriasis spot on arms and leg)) and VACCINATION SITE PAIN (covid vaccine issue like injection site pain). At the time of the report, PSORIASIS (psoriasis flare up (psoriasis spot on arms and leg)) and VACCINATION SITE PAIN (covid vaccine issue like injection site pain) 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: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Inappropriate schedule of product administration, Sinusitis
Clinical narrative: Sinus infection; COVID; Arthritis pain; 1st dose was administerd on 04-FEB-2021 and the 2nd dose on  29-MAR-2021; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), COVID-19 (COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administerd on 04-FEB-2021 and the 2nd dose on  29-MAR-2021) and ARTHRALGIA (Arthritis pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 04-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 29-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administerd on 04-FEB-2021 and the 2nd dose on  29-MAR-2021). In July 2021, the patient experienced ARTHRALGIA (Arthritis pain). In February 2022, the patient experienced COVID-19 (COVID). On 15-Mar-2022, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administerd on 04-FEB-2021 and the 2nd dose on  29-MAR-2021) outcome was unknown, COVID-19 (COVID) was resolving and ARTHRALGIA (Arthritis pain) had not resolved.            No concomitant medication was reported. In July 2021, the patient experienced ARTHRITIS PAIN. In February 2022, the patient experienced COVID. On 15 Mar 2022, the patient experienced SINUS INFECTION. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  On Feb 2022, patient had COVID and she still had the cough. On 15 Mar 2022, she was home sick with what she thought was a sinus infection. She also had a low grade fever. She thought that the two COVID vaccines triggered her RA and started to feel the arthritis pain about four months later after the vaccines.  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: 27.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Brain injury, Crohn's disease, Lyme disease, Stress
Clinical narrative: Brain damage; Crohn's disease relapse; Stress; Lyme disease; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN INJURY (Brain damage), LYME DISEASE (Lyme disease) and CROHN'S DISEASE (Crohn's disease relapse) in a 27-year-old male 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) injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced LYME DISEASE (Lyme disease) (seriousness criterion medically significant). On an unknown date, the patient experienced BRAIN INJURY (Brain damage) (seriousness criterion medically significant), CROHN'S DISEASE (Crohn's disease relapse) (seriousness criterion medically significant) and STRESS (Stress). At the time of the report, BRAIN INJURY (Brain damage) and STRESS (Stress) outcome was unknown and LYME DISEASE (Lyme disease) and CROHN'S DISEASE (Crohn's disease relapse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  Patient had TICK BITE FROM A DOG   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment: This spontaneous case concerns a 27-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Brain injury, Lyme disease, and Crohn's disease after receiving the 1st dose of mRNA-1273 vaccine on an unknown date. Patient experienced Crohn's flare after vaccination. Clinical course and treatment details were not reported. It was reported that patient got tick bite from dog. On unknown date, patient received Adalimumab (unknown indication) which could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 27-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Brain injury, Lyme disease, and Crohn's disease after receiving the 1st dose of mRNA-1273 vaccine on an unknown date. Patient experienced Crohn's flare  after vaccination. Clinical course and treatment details were not reported. It was reported that patient got tick bite from dog. On unknown date, patient received Adalimumab (unknown indication) which could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein, Inflammation, Neutrophil count, Neutrophil count increased
Clinical narrative: Neutrophils increased; Inflammation; White blood cell count increased; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUTROPHIL COUNT INCREASED (Neutrophils increased), INFLAMMATION (Inflammation), WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and ARTHRALGIA (Shoulder pain) in a 63-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 Ulcerative colitis.    No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 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) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced NEUTROPHIL COUNT INCREASED (Neutrophils increased), INFLAMMATION (Inflammation) and WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased). At the time of the report, NEUTROPHIL COUNT INCREASED (Neutrophils increased), INFLAMMATION (Inflammation) and WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) had not resolved and ARTHRALGIA (Shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Neutrophil count: 3700. In January 2022, White blood cell count: 5.7. In 2022, C-reactive protein: inflammation marker at 56. In 2022, Neutrophil count: elevated at 8800. In 2022, White blood cell count: elevated at 10.7.         Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with Humira for the event(s) of neutrophils elevated at 8800, inflammation and white blood count numbers elevated at 10.7 was not provided. The reporter's causality for the event(s) of right shoulder hurting 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
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: Neutrophils increased; Inflammation; White blood cell count increased; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUTROPHIL COUNT INCREASED (Neutrophils increased), INFLAMMATION (Inflammation), WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) and ARTHRALGIA (Shoulder pain) in a 63-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 Ulcerative colitis.    No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 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) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (Shoulder pain). On an unknown date, the patient experienced NEUTROPHIL COUNT INCREASED (Neutrophils increased), INFLAMMATION (Inflammation) and WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased). At the time of the report, NEUTROPHIL COUNT INCREASED (Neutrophils increased), INFLAMMATION (Inflammation) and WHITE BLOOD CELL COUNT INCREASED (White blood cell count increased) had not resolved and ARTHRALGIA (Shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Neutrophil count: 3700. In January 2022, White blood cell count: 5.7. In 2022, C-reactive protein: inflammation marker at 56. In 2022, Neutrophil count: elevated at 8800. In 2022, White blood cell count: elevated at 10.7.         Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with Humira for the event(s) of neutrophils elevated at 8800, inflammation and white blood count numbers elevated at 10.7 was not provided. The reporter's causality for the event(s) of right shoulder hurting 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: 46.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Sciatica
Clinical narrative: Sciatica; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatica) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced SCIATICA (Sciatica). At the time of the report, SCIATICA (Sciatica) had not resolved.            No concomitant medication was reported. On an unknown date, the patient experienced Sciatica. No treatment medication was reported. 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.    Causality for HUMIRA(ADALIMUMAB):The reporter's causality for the event(s) of SCIATICA with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Significant follow-up received: Event back pain was updated to Sciatica. Humira indication and ongoing status were updated. Reporter causality was updated.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Feeling cold, Headache, Somnolence, Vaccination site pain
Clinical narrative: 2nd day sleepiness; Body went actually cold instead of fevers; Low appetite on 2nd day; Very mild headaches; Soreness in vaxx place/Soreness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (2nd day sleepiness), FEELING COLD (Body went actually cold instead of fevers), DECREASED APPETITE (Low appetite on 2nd day), HEADACHE (Very mild headaches) and VACCINATION SITE PAIN (Soreness in vaxx place/Soreness) 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 TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (2nd day sleepiness), FEELING COLD (Body went actually cold instead of fevers), DECREASED APPETITE (Low appetite on 2nd day), HEADACHE (Very mild headaches) and VACCINATION SITE PAIN (Soreness in vaxx place/Soreness). At the time of the report, SOMNOLENCE (2nd day sleepiness), FEELING COLD (Body went actually cold instead of fevers), DECREASED APPETITE (Low appetite on 2nd day), HEADACHE (Very mild headaches) and VACCINATION SITE PAIN (Soreness in vaxx place/Soreness) outcome was unknown.            No concomitant medications were reported.  It was reported that current status of third vaxx being a different one and patient had no itchiness rash and barely any swelling.  No treatment details 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Condition aggravated, Dyspnoea, Echocardiogram, Fatigue
Clinical narrative: FLARE UPS; she now had shorter breath; She had allergic reaction so not on Humira; felt more fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UPS), DYSPNOEA (she now had shorter breath), HYPERSENSITIVITY (She had allergic reaction so not on Humira) and FATIGUE (felt more fatigue) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Crohn's disease and TICAGRELOR (BRILINTA) for an unknown indication.    The patient's past medical history included Cardiomyopathy on 20-Feb-2020, Heart attack from 20-Feb-2020 to September 2020, Catheterization cardiac in February 2020 and Stent placement (3 stents due to heart attack) in February 2020. Concurrent medical conditions included Passive smoking, Allergic reaction to drug since 2020, Crohn's disease and Rheumatoid arthritis since 2017.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and TICAGRELOR (BRILINTA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UPS), DYSPNOEA (she now had shorter breath), HYPERSENSITIVITY (She had allergic reaction so not on Humira) and FATIGUE (felt more fatigue). At the time of the report, CONDITION AGGRAVATED (FLARE UPS), DYSPNOEA (she now had shorter breath), HYPERSENSITIVITY (She had allergic reaction so not on Humira) and FATIGUE (felt more fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2020, Chest X-ray: Normal. On 20-Feb-2020, Echocardiogram: Heart attack and heart muscles weakness was observed.. On 20-Feb-2020, Troponin: Elevated.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  HUMIRA 40MG/0.4ML(40 Milligram 1mg in 14 Day) Patient was discharged on 23 Feb 2020. Few days after discharge patient went back hospital due to terrible allergic reaction, had with Brilinta medication wherein patient breakout in hives and shortness of breath.  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
Symptoms: Hypersensitivity, Troponin
Clinical narrative: FLARE UPS; she now had shorter breath; She had allergic reaction so not on Humira; felt more fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UPS), DYSPNOEA (she now had shorter breath), HYPERSENSITIVITY (She had allergic reaction so not on Humira) and FATIGUE (felt more fatigue) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Crohn's disease and TICAGRELOR (BRILINTA) for an unknown indication.    The patient's past medical history included Cardiomyopathy on 20-Feb-2020, Heart attack from 20-Feb-2020 to September 2020, Catheterization cardiac in February 2020 and Stent placement (3 stents due to heart attack) in February 2020. Concurrent medical conditions included Passive smoking, Allergic reaction to drug since 2020, Crohn's disease and Rheumatoid arthritis since 2017.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and TICAGRELOR (BRILINTA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UPS), DYSPNOEA (she now had shorter breath), HYPERSENSITIVITY (She had allergic reaction so not on Humira) and FATIGUE (felt more fatigue). At the time of the report, CONDITION AGGRAVATED (FLARE UPS), DYSPNOEA (she now had shorter breath), HYPERSENSITIVITY (She had allergic reaction so not on Humira) and FATIGUE (felt more fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2020, Chest X-ray: Normal. On 20-Feb-2020, Echocardiogram: Heart attack and heart muscles weakness was observed.. On 20-Feb-2020, Troponin: Elevated.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  HUMIRA 40MG/0.4ML(40 Milligram 1mg in 14 Day) Patient was discharged on 23 Feb 2020. Few days after discharge patient went back hospital due to terrible allergic reaction, had with Brilinta medication wherein patient breakout in hives and shortness of breath.  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: Asthenia, Gait inability, Joint range of motion decreased, Pain in extremity, Paraesthesia
Clinical narrative: Joint range of motion decreased/Could not open/close hand; Unable to walk/Could not walk; Loss of energy/No energy; Paraesthesia hand/Pins and needles feeling in both wrist; Local swelling/Swelling in tendon inside the right ankle; Painful hand/Hands were painful to open in the morning; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/Could not open/close hand), GAIT INABILITY (Unable to walk/Could not walk), ASTHENIA (Loss of energy/No energy), PARAESTHESIA (Paraesthesia hand/Pins and needles feeling in both wrist) and SWELLING (Local swelling/Swelling in tendon inside the right ankle) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   In 2022, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/Could not open/close hand), GAIT INABILITY (Unable to walk/Could not walk), ASTHENIA (Loss of energy/No energy), PARAESTHESIA (Paraesthesia hand/Pins and needles feeling in both wrist), SWELLING (Local swelling/Swelling in tendon inside the right ankle) and PAIN IN EXTREMITY (Painful hand/Hands were painful to open in the morning). At the time of the report, JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/Could not open/close hand), GAIT INABILITY (Unable to walk/Could not walk), ASTHENIA (Loss of energy/No energy), PARAESTHESIA (Paraesthesia hand/Pins and needles feeling in both wrist), SWELLING (Local swelling/Swelling in tendon inside the right ankle) and PAIN IN EXTREMITY (Painful hand/Hands were painful to open in the morning) outcome was unknown.            This case was identified as part of a retrospective clean-up activity received in the Moderna  were missed to be booked-in.  No concomitant medication was provided.  No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Swelling
Clinical narrative: Joint range of motion decreased/Could not open/close hand; Unable to walk/Could not walk; Loss of energy/No energy; Paraesthesia hand/Pins and needles feeling in both wrist; Local swelling/Swelling in tendon inside the right ankle; Painful hand/Hands were painful to open in the morning; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/Could not open/close hand), GAIT INABILITY (Unable to walk/Could not walk), ASTHENIA (Loss of energy/No energy), PARAESTHESIA (Paraesthesia hand/Pins and needles feeling in both wrist) and SWELLING (Local swelling/Swelling in tendon inside the right ankle) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   In 2022, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/Could not open/close hand), GAIT INABILITY (Unable to walk/Could not walk), ASTHENIA (Loss of energy/No energy), PARAESTHESIA (Paraesthesia hand/Pins and needles feeling in both wrist), SWELLING (Local swelling/Swelling in tendon inside the right ankle) and PAIN IN EXTREMITY (Painful hand/Hands were painful to open in the morning). At the time of the report, JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/Could not open/close hand), GAIT INABILITY (Unable to walk/Could not walk), ASTHENIA (Loss of energy/No energy), PARAESTHESIA (Paraesthesia hand/Pins and needles feeling in both wrist), SWELLING (Local swelling/Swelling in tendon inside the right ankle) and PAIN IN EXTREMITY (Painful hand/Hands were painful to open in the morning) outcome was unknown.            This case was identified as part of a retrospective clean-up activity received in the Moderna  were missed to be booked-in.  No concomitant medication was provided.  No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Running nose; a sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose) and OROPHARYNGEAL PAIN (a sore throat) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Running nose) and OROPHARYNGEAL PAIN (a sore throat). At the time of the report, RHINORRHOEA (Running nose) and OROPHARYNGEAL PAIN (a sore throat) outcome was unknown.            No concomitant medication was reported. It was reported that the patient was vaccinated (2 times with Moderna and his booster was Biontech/Pfizer). The patient suffered from a running nose and a sore throat. No treatment medication 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Glycosylated haemoglobin, Red blood cell count, Red blood cell count abnormal, SARS-CoV-2 test
Clinical narrative: White blood cell count abnormal/White Blood Cell Count was 3.8; Red blood cell count abnormal/Red Blood Cell Count was 4.44; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT ABNORMAL (White blood cell count abnormal/White Blood Cell Count was 3.8), RED BLOOD CELL COUNT ABNORMAL (Red blood cell count abnormal/Red Blood Cell Count was 4.44) and COVID-19 (COVID-19) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukemia and IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia.   On 22-Sep-2016, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In 2022, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT ABNORMAL (White blood cell count abnormal/White Blood Cell Count was 3.8) and RED BLOOD CELL COUNT ABNORMAL (Red blood cell count abnormal/Red Blood Cell Count was 4.44). The patient was treated with SOTROVIMAB at an unspecified dose and frequency. At the time of the report, WHITE BLOOD CELL COUNT ABNORMAL (White blood cell count abnormal/White Blood Cell Count was 3.8) and RED BLOOD CELL COUNT ABNORMAL (Red blood cell count abnormal/Red Blood Cell Count was 4.44) outcome was unknown and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2022, SARS-CoV-2 test: COVID-19. On an unknown date, Glycosylated haemoglobin: 5.6. On an unknown date, Red blood cell count: 4.44. On an unknown date, White blood cell count: 3.8.   No concomitant medication details were provided.  The reporter's causality for the event of white blood cell count abnormal with IMBRUVICA(IBRUTINIB) tablet was a reasonable possibility and not provided for other events.  The reporter's causality for the events of white blood cell count abnormal, Red blood cell count abnormal and COVID-19 with IMBRUVICA(IBRUTINIB) 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: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count abnormal
Clinical narrative: White blood cell count abnormal/White Blood Cell Count was 3.8; Red blood cell count abnormal/Red Blood Cell Count was 4.44; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT ABNORMAL (White blood cell count abnormal/White Blood Cell Count was 3.8), RED BLOOD CELL COUNT ABNORMAL (Red blood cell count abnormal/Red Blood Cell Count was 4.44) and COVID-19 (COVID-19) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukemia and IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia.   On 22-Sep-2016, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In 2022, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT ABNORMAL (White blood cell count abnormal/White Blood Cell Count was 3.8) and RED BLOOD CELL COUNT ABNORMAL (Red blood cell count abnormal/Red Blood Cell Count was 4.44). The patient was treated with SOTROVIMAB at an unspecified dose and frequency. At the time of the report, WHITE BLOOD CELL COUNT ABNORMAL (White blood cell count abnormal/White Blood Cell Count was 3.8) and RED BLOOD CELL COUNT ABNORMAL (Red blood cell count abnormal/Red Blood Cell Count was 4.44) outcome was unknown and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2022, SARS-CoV-2 test: COVID-19. On an unknown date, Glycosylated haemoglobin: 5.6. On an unknown date, Red blood cell count: 4.44. On an unknown date, White blood cell count: 3.8.   No concomitant medication details were provided.  The reporter's causality for the event of white blood cell count abnormal with IMBRUVICA(IBRUTINIB) tablet was a reasonable possibility and not provided for other events.  The reporter's causality for the events of white blood cell count abnormal, Red blood cell count abnormal and COVID-19 with IMBRUVICA(IBRUTINIB) was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: 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 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Biontech and AstraZeneca vaccin (Vaxzevria). Past adverse reactions to the above products included No adverse event with AstraZeneca vaccin (Vaxzevria) and Biontech.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (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.            No concomitant medications was reported. No treatment medications 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.
Sex: F
Vaccine: COVID19
Symptoms: Dermal cyst, Dyspnoea, Illness, Mass, Tooth loss
Clinical narrative: Sickness; Skin cysts/Two cysts on right arm; Tooth loss/Teeth felling out; Mass/Lump in right side of nose; Difficulty breathing/Hard to breath; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), DERMAL CYST (Skin cysts/Two cysts on right arm), TOOTH LOSS (Tooth loss/Teeth felling out), MASS (Mass/Lump in right side of nose) and DYSPNOEA (Difficulty breathing/Hard to breath) 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) injection for Rheumatoid arthritis.    No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sickness), DERMAL CYST (Skin cysts/Two cysts on right arm), TOOTH LOSS (Tooth loss/Teeth felling out), MASS (Mass/Lump in right side of nose) and DYSPNOEA (Difficulty breathing/Hard to breath). At the time of the report, ILLNESS (Sickness) had resolved, DERMAL CYST (Skin cysts/Two cysts on right arm), TOOTH LOSS (Tooth loss/Teeth felling out) and MASS (Mass/Lump in right side of nose) had not resolved and DYSPNOEA (Difficulty breathing/Hard to breath) 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 was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of sick, two cysts on right arm, teeth felling out and lump in right side of nose with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of hard to breath was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) in a 41-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 and Rheumatoid arthritis.    No Medical History information was reported.   On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, citrate free. In October 2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash). In October 2021, VACCINATION SITE RASH (Vaccination site rash) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication details were provided. No treatment medication details were provided.   The reporter's causality for the event of vaccination site rash with HUMIRA was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the information was not available in the patient's file.  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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Respiratory disorder
Clinical narrative: BREATHING PROBLEMS; Chest pain; DIZZY SPELL/LIGHT HEADEDNESS; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (BREATHING PROBLEMS), CHEST PAIN (Chest pain), DIZZINESS (DIZZY SPELL/LIGHT HEADEDNESS) and HEADACHE (Headache) 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.    No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-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) Citrate Free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced RESPIRATORY DISORDER (BREATHING PROBLEMS), CHEST PAIN (Chest pain), DIZZINESS (DIZZY SPELL/LIGHT HEADEDNESS) and HEADACHE (Headache). At the time of the report, RESPIRATORY DISORDER (BREATHING PROBLEMS), CHEST PAIN (Chest pain) and HEADACHE (Headache) had not resolved and DIZZINESS (DIZZY SPELL/LIGHT HEADEDNESS) outcome was unknown.            It was unknown if the patient was enrolled in COVID-19 vaccine trails.  No concomitant medication were reported.  It was reported that the reporters causality for the events BREATHING PROBLEMS, CHEST PAIN, HEADACHE AND DIZZY SPELL/LIGHT HEADEDNESS were not provided  No treatment medication 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 24-Jun-2022: Follow up received contains significant information updated LOT number of suspect drug humira and events added.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form, dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.