chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Psoriasis
Clinical narrative: PSORIASIS CLEARING ON FACE; AXILLA BUT PRESENT ON COCCYX; ACHE ALL OVER; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS CLEARING ON FACE), MYALGIA (AXILLA BUT PRESENT ON COCCYX) and PAIN (ACHE ALL OVER) 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 Plaque psoriasis.    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 01-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) (unknown route) CF. On 01-Nov-2021, the patient experienced MYALGIA (AXILLA BUT PRESENT ON COCCYX) and PAIN (ACHE ALL OVER). On an unknown date, the patient experienced PSORIASIS (PSORIASIS CLEARING ON FACE). On 02-Nov-2021, MYALGIA (AXILLA BUT PRESENT ON COCCYX) and PAIN (ACHE ALL OVER) had resolved. At the time of the report, PSORIASIS (PSORIASIS CLEARING ON FACE) was resolving.            No concomitant products were reported.  On an unknown date, the patient experienced psoriasis clearing on face, axilla but present on coccyx, back. On 01-Nov-2021, the patient experienced muscle pain and ache all over. On 02-Nov-2021, the muscle pain and ache all over resolved. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 01-Mar-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 01-Apr-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna. On 01-Nov-2021, patient received 3rd dose covid-19 vaccine manufactured by moderna.  Causality for humira (adalimumab) The reporter's causality for the event(s) of psoriasis clearing on face, axilla but present on coccyx, back,  muscle pain and ache all over was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Skin disorder, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Skin disorder; Blood glucose increased; Vaccination site pruritus; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Skin disorder), BLOOD GLUCOSE INCREASED (Blood glucose increased), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Lymphocytic lymphoma.    The patient's past medical history included Basal cell carcinoma and Basal cell carcinoma excision (Basal cell carcinoma removal).   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 01-Jun-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On an unknown date, the patient experienced SKIN DISORDER (Skin disorder) and BLOOD GLUCOSE INCREASED (Blood glucose increased). In 2021, VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved. At the time of the report, SKIN DISORDER (Skin disorder) outcome was unknown and BLOOD GLUCOSE INCREASED (Blood glucose increased) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased.         Concomitant medication was not reported.  Treatment medication was not reported.   The patient had events of non-serious skin change/concerning spot in the middle of back, glycemic spike and covid arm in which the injection site was red and itchy with imbruvica (ibrutinib). On unknown dates, the patient experienced skin change/concerning spot in the middle of back and glycemic spike. In 2021, the patient experienced covid arm in which the injection site was red and itchy. In 2021, the covid arm in which the injection site was red and itchy resolved. On an unknown date, glycemic spike resolved. Covid-19 vaccine moderna (elasomeran) was also considered suspect.  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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Diarrhoea, Inappropriate schedule of product administration, Nervousness
Clinical narrative: Diarrhea if becomes anxious or nervous; Diarrhea if becomes anxious or nervous; Chest tightness; Diarrhea if becomes anxious or nervous; Patient received first dose on 30-Mar-2021 and second dose on 20-Apr-2021; Sore arm with Covid vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Diarrhea if becomes anxious or nervous), NERVOUSNESS (Diarrhea if becomes anxious or nervous), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea if becomes anxious or nervous) and PAIN IN EXTREMITY (Sore arm with Covid vaccines) in a 35-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 Crohn's disease.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 30-Mar-2021 and second dose on 20-Apr-2021). In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm with Covid vaccines). On an unknown date, the patient experienced ANXIETY (Diarrhea if becomes anxious or nervous), NERVOUSNESS (Diarrhea if becomes anxious or nervous), CHEST DISCOMFORT (Chest tightness) and DIARRHOEA (Diarrhea if becomes anxious or nervous). At the time of the report, ANXIETY (Diarrhea if becomes anxious or nervous), NERVOUSNESS (Diarrhea if becomes anxious or nervous), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea if becomes anxious or nervous), PAIN IN EXTREMITY (Sore arm with Covid vaccines) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 30-Mar-2021 and second dose on 20-Apr-2021) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality with Humira for the events of sore arm with COVID vaccines, diarrhea if becomes anxious or nervous and chest tightness was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624775 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Additional follow up received, added event of chest tightness.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Diarrhea if becomes anxious or nervous; Diarrhea if becomes anxious or nervous; Chest tightness; Diarrhea if becomes anxious or nervous; Patient received first dose on 30-Mar-2021 and second dose on 20-Apr-2021; Sore arm with Covid vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Diarrhea if becomes anxious or nervous), NERVOUSNESS (Diarrhea if becomes anxious or nervous), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea if becomes anxious or nervous) and PAIN IN EXTREMITY (Sore arm with Covid vaccines) in a 35-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 Crohn's disease.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 30-Mar-2021 and second dose on 20-Apr-2021). In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm with Covid vaccines). On an unknown date, the patient experienced ANXIETY (Diarrhea if becomes anxious or nervous), NERVOUSNESS (Diarrhea if becomes anxious or nervous), CHEST DISCOMFORT (Chest tightness) and DIARRHOEA (Diarrhea if becomes anxious or nervous). At the time of the report, ANXIETY (Diarrhea if becomes anxious or nervous), NERVOUSNESS (Diarrhea if becomes anxious or nervous), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea if becomes anxious or nervous), PAIN IN EXTREMITY (Sore arm with Covid vaccines) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 30-Mar-2021 and second dose on 20-Apr-2021) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality with Humira for the events of sore arm with COVID vaccines, diarrhea if becomes anxious or nervous and chest tightness was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624775 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Additional follow up received, added event of chest tightness.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Vaccination site pain
Clinical narrative: Arthritis in both knees; Ankle hurting; Sore arm after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis in both knees), ARTHRALGIA (Ankle hurting) and VACCINATION SITE PAIN (Sore arm after COVID vaccine) in a 43-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 an unknown indication.    The patient's past medical history included Broken ankle in 2004.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, UNK. On an unknown date, the patient experienced ARTHRITIS (Arthritis in both knees), ARTHRALGIA (Ankle hurting) and VACCINATION SITE PAIN (Sore arm after COVID vaccine). At the time of the report, ARTHRITIS (Arthritis in both knees) and ARTHRALGIA (Ankle hurting) had not resolved and VACCINATION SITE PAIN (Sore arm after COVID vaccine) had resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality with Humira for the events Arthritis and Arthralgia 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Psoriasis, Skin disorder
Clinical narrative: Spots on elbows; Plaque psoriasis flare on hands; Primary series completed on 16-Apr-2021 and 3rd dose on 31-Aug-2021; Flu like symptoms following COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms following COVID vaccine), SKIN DISORDER (Spots on elbows), PSORIASIS (Plaque psoriasis flare on hands) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series completed on 16-Apr-2021 and 3rd dose on 31-Aug-2021) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series completed on 16-Apr-2021 and 3rd dose on 31-Aug-2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms following COVID vaccine), SKIN DISORDER (Spots on elbows) and PSORIASIS (Plaque psoriasis flare on hands). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms following COVID vaccine) had resolved, SKIN DISORDER (Spots on elbows) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary series completed on 16-Apr-2021 and 3rd dose on 31-Aug-2021) outcome was unknown and PSORIASIS (Plaque psoriasis flare on hands) was resolving.            No concomitant product was reported. Patient had plaque psoriasis flare on hands and it was clearing as of now. She was still peeling and cracking. She had spots on elbows. She had 24 hours of flu like symptoms following the COVID vaccine. No treatment 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.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Retinal scar
Clinical narrative: SCAR TISSUE OVER RETINA IN RIGHT EYE; MUSCLE ACHES FROM SECOND MODERNA VACCINE; MUSCLE ACHES FROM BOOSTER MODERNA VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL SCAR (SCAR TISSUE OVER RETINA IN RIGHT EYE), MYALGIA (MUSCLE ACHES FROM BOOSTER MODERNA VACCINE) and MYALGIA (MUSCLE ACHES FROM SECOND MODERNA VACCINE) in a 44-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 Panuveitis.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) UNK - Ongoi. In June 2021, the patient experienced MYALGIA (MUSCLE ACHES FROM BOOSTER MODERNA VACCINE). In December 2021, the patient experienced MYALGIA (MUSCLE ACHES FROM SECOND MODERNA VACCINE). On an unknown date, the patient experienced RETINAL SCAR (SCAR TISSUE OVER RETINA IN RIGHT EYE). At the time of the report, RETINAL SCAR (SCAR TISSUE OVER RETINA IN RIGHT EYE) had not resolved and MYALGIA (MUSCLE ACHES FROM BOOSTER MODERNA VACCINE) and MYALGIA (MUSCLE ACHES FROM SECOND MODERNA VACCINE) outcome was unknown.            No concomitant products were reported.  On an unknown date, the patient experienced scar tissue over retina in right eye. In June 2021, the patient experienced muscle aches from second moderna vaccine. In December 2021, the patient experienced muscle aches from booster moderna vaccine. moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 20-May-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 20-Jun-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna. On 08-Dec-2021, patient received booster dose covid-19 vaccine manufactured by moderna.  Causality for humira (adalimumab) The reporter's causality for the event(s) of scar tissue over retina in right eye with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of muscle aches from second moderna vaccine and muscle aches from booster moderna vaccine with humira(adalimumab) was no reasonable possibility.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for an unknown indication.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-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 IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient experienced VOMITING (Vomiting) (seriousness criterion hospitalization). At the time of the report, VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported. The patient had her covid booster dose and was hospitalized due to vomiting. On 15-Sep-2021, patient received booster dose of Moderna COVID-19 Vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of IMBRUVICA as per reporter for event vomiting 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.  Company comment-This spontaneous case concerns an elderly  female patient of unspecified age with no medical history reported, who experienced the unexpected serious (hospitalization) event of Vomiting on an unknown date after third dose of mRNA-1273 vaccination. Patient had received 1st and 2nd doses of same vaccine at an interval of one month and third dose six months later. Patient was hospitalized due to vomiting after booster dose. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns an elderly  female patient of unspecified age with no medical history reported, who experienced the unexpected serious (hospitalization) event of Vomiting on an unknown date after third dose of mRNA-1273 vaccination. Patient had received 1st and 2nd doses of same vaccine at an interval of one month and third dose six months later. Patient was hospitalized due to vomiting after booster dose. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site bruising
Clinical narrative: Bruised from the injection; 1st dose 15-Apr-2021 and 2nd dose 04-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruised from the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-Apr-2021 and 2nd dose 04-May-2021) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2022, 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 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-Apr-2021 and 2nd dose 04-May-2021). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Bruised from the injection). At the time of the report, VACCINATION SITE BRUISING (Bruised from the injection) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-Apr-2021 and 2nd dose 04-May-2021) outcome was unknown.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality for the event with Humira was a 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Hypertension, SARS-CoV-2 test
Clinical narrative: Hypertension; Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID) and HYPERTENSION (Hypertension) in a 74-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.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 July 2021, the patient experienced COVID-19 (Contracted COVID). On an unknown date, the patient experienced HYPERTENSION (Hypertension). At the time of the report, COVID-19 (Contracted COVID) had resolved with sequelae and HYPERTENSION (Hypertension) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Blood pressure measurement: High.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. The primary reporter did not have the lot number information, because the packaging was discarded.  No treatment medication was reported.  The reporters causality for the events of contracted COVID and hypertension was not provided for co-suspect Humira.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Achy for a short time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy for a short time) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    Concomitant products included PREDNISONE for an unknown indication.   In April 2021, the patient received second 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 and METHOTREXATE (Oral) at an unspecified dose. In April 2021, the patient experienced PAIN (Achy for a short time). At the time of the report, PAIN (Achy for a short time) had resolved.            No treatment information mentioned. No medical history provided.  Patient had a fever after the first vaccine for 24 hours and felt achy for a short while after the second vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-620820, MOD-2021-620836 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Gingival disorder
Clinical narrative: Gum disorder; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL DISORDER (Gum disorder) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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) Unknown. On an unknown date, the patient experienced GINGIVAL DISORDER (Gum disorder). At the time of the report, GINGIVAL DISORDER (Gum disorder) had not resolved.            No concomitant medications were reported No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Dry throat, Rhinorrhoea, Viral test
Clinical narrative: runny nose; Dry throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and DRY THROAT (Dry throat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Previously administered products included for Drug use for unknown indication: Biontech. Past adverse reactions to the above products included No adverse event with Biontech.    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 RHINORRHOEA (runny nose) and DRY THROAT (Dry throat). At the time of the report, RHINORRHOEA (runny nose) and DRY THROAT (Dry throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral test: (Positive) positive, (Positive) positive and (Positive) positive.         No concomitant medication was reported.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Pyrexia
Clinical narrative: REACTION TO SECOND COVID VACCINE; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (REACTION TO SECOND COVID VACCINE) and PYREXIA (FEVER) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and third 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 IMMUNISATION REACTION (REACTION TO SECOND COVID VACCINE) and PYREXIA (FEVER). At the time of the report, IMMUNISATION REACTION (REACTION TO SECOND COVID VACCINE) and PYREXIA (FEVER) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Hidradenitis
Clinical narrative: Hidradenitis suppurativa; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa) 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 Hidradenitis suppurativa.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa) outcome was unknown.            No concomitant medications were reported.  Patient had hidradenitis suppurativa flare up.  No treatment medications were reported.  The reporter assessed the event as probably related to Moderna vaccine and not reasonably possible with Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Stomal hernia
Clinical narrative: hernia around colostomy opening; This spontaneous case was reported by a consumer and describes the occurrence of STOMAL HERNIA (hernia around colostomy opening) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Colostomy. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced STOMAL HERNIA (hernia around colostomy opening). At the time of the report, STOMAL HERNIA (hernia around colostomy opening) outcome was unknown.            No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira for the event(s) of hernia around colostomy opening unknown onset and hernia around colostomy opening unknown onset was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: TERRIBLE REACTION TO THE FOURTH DOSE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (TERRIBLE REACTION TO THE FOURTH 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 IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient experienced IMMUNISATION REACTION (TERRIBLE REACTION TO THE FOURTH DOSE). At the time of the report, IMMUNISATION REACTION (TERRIBLE REACTION TO THE FOURTH DOSE) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (STROKE) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced CEREBROVASCULAR ACCIDENT (STROKE) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (STROKE) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   COVID-19 vaccine taken one in once. Humira was citrate free.  In 2022, the patient had a stroke. She was concerned if Humira was the cause and whether Humira was working, but, she felt Humira was not working.  No treatment drug information was provided.  The reporter's causality for the event of Stroke with Humira (Adalimumab) was a reasonable possibility. The reporter's causality with Humira (Adalimumab) for the event of humira was not working was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 63-year-old female patient with current medication of Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Cerebrovascular accident, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor the exact event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The co-suspect drug Adalimumab remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 63-year-old female patient with current medication of Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Cerebrovascular accident, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor the exact event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The co-suspect drug Adalimumab remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Pain localized; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain localized), CHILLS (Chills) and PYREXIA (Fever) 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 Crohn's disease.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In 2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 11-Mar-2022, the patient experienced PAIN (Pain localized). At the time of the report, PAIN (Pain localized) outcome was unknown and CHILLS (Chills) and PYREXIA (Fever) had resolved.            No concomitant medications were reported.   In 2021, the patient experienced chills and fever. On 11-Mar-2022, the patient experienced twinges on side/pain was quick but sharp enough to pause walking. On unknown dates, chills and fever resolved. Moderna was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication 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.
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Gastrointestinal disorder
Clinical narrative: Bowel incontinence; Colopathy; This spontaneous case was reported by a consumer and describes the occurrence of ANAL INCONTINENCE (Bowel incontinence) and GASTROINTESTINAL DISORDER (Colopathy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 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, the patient experienced ANAL INCONTINENCE (Bowel incontinence) and GASTROINTESTINAL DISORDER (Colopathy). At the time of the report, ANAL INCONTINENCE (Bowel incontinence) had not resolved and GASTROINTESTINAL DISORDER (Colopathy) had resolved.            No concomitant medications were reported.   On unknown dates, the patient experienced had episodes of felt like hard to control bowel movements and covid vaccine caused colon to felt worsened. On an unknown date, covid vaccine caused colon to felt worsened resolved.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Breast mass, Colonoscopy, Large intestine polyp, Limb mass, Nodule
Clinical narrative: Upper extremity mass; Breast lump; Colonic polyp; Painful nodule; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Upper extremity mass), BREAST MASS (Breast lump), LARGE INTESTINE POLYP (Colonic polyp) and NODULE (Painful nodule) in a 66-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 Ulcerative colitis.    No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced LIMB MASS (Upper extremity mass), BREAST MASS (Breast lump), LARGE INTESTINE POLYP (Colonic polyp) and NODULE (Painful nodule). At the time of the report, LIMB MASS (Upper extremity mass), BREAST MASS (Breast lump), LARGE INTESTINE POLYP (Colonic polyp) and NODULE (Painful nodule) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: 80 T0 90 POLYPS.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 lump in elbow size of a dime, lump in left breast, 80 t0 90 polyps in colonoscopy and lumps in muscle joints hurted after vaccination/in legs, feet, hands and arms in extremities was not provided.  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: F
Vaccine: COVID19
Symptoms: Influenza, Migraine, Pruritus, Vaccination site pain, Vitamin D
Clinical narrative: Migraine; Vitamin D low; Flu; Itchy; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), VITAMIN D DECREASED (Vitamin D low), INFLUENZA (Flu), PRURITUS (Itchy) and VACCINATION SITE PAIN (Vaccination site pain) in a 43-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (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) Citrate Free. On an unknown date, the patient experienced MIGRAINE (Migraine), VITAMIN D DECREASED (Vitamin D low), INFLUENZA (Flu), PRURITUS (Itchy) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, MIGRAINE (Migraine), VITAMIN D DECREASED (Vitamin D low), INFLUENZA (Flu), PRURITUS (Itchy) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: Low.         Concomitant Drugs Not Reported  The reporter's causality with Humira for the event(s) of migraine, low vitamin d, vaccination site sore, flu and vaccination site itchy was not provided.  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: F
Vaccine: COVID19
Symptoms: Vitamin D decreased
Clinical narrative: Migraine; Vitamin D low; Flu; Itchy; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), VITAMIN D DECREASED (Vitamin D low), INFLUENZA (Flu), PRURITUS (Itchy) and VACCINATION SITE PAIN (Vaccination site pain) in a 43-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (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) Citrate Free. On an unknown date, the patient experienced MIGRAINE (Migraine), VITAMIN D DECREASED (Vitamin D low), INFLUENZA (Flu), PRURITUS (Itchy) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, MIGRAINE (Migraine), VITAMIN D DECREASED (Vitamin D low), INFLUENZA (Flu), PRURITUS (Itchy) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: Low.         Concomitant Drugs Not Reported  The reporter's causality with Humira for the event(s) of migraine, low vitamin d, vaccination site sore, flu and vaccination site itchy was not provided.  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