chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Pain
Clinical narrative: Weakness; Ache; Headache; Ache; Headache; Weakness; Weakness; Ache; Headache; Nausea / nausea occurred about eight times; Feelings of weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feelings of weakness), the first episode of ASTHENIA (Weakness), the second episode of ASTHENIA (Weakness), the third episode of ASTHENIA (Weakness) and the first episode of PAIN (Ache) in a 55-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 Ulcerative colitis.    No Medical History information was reported.   In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 25-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced ASTHENIA (Feelings of weakness) and NAUSEA (Nausea / nausea occurred about eight times). On 25-Jan-2021, the patient experienced the first episode of ASTHENIA (Weakness), the first episode of PAIN (Ache) and the first episode of HEADACHE (Headache). On 22-Feb-2021, the patient experienced the second episode of ASTHENIA (Weakness), the second episode of PAIN (Ache) and the second episode of HEADACHE (Headache). In 2021, the patient experienced the third episode of ASTHENIA (Weakness), the third episode of PAIN (Ache) and the third episode of HEADACHE (Headache). In 2021, last episode of ASTHENIA (Weakness), the last episode of PAIN (Ache) and the last episode of HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Feelings of weakness) had resolved and NAUSEA (Nausea / nausea occurred about eight times) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of FEELING WEAK and NAUSEA OCCURRED ABOUT EIGHT TIMES with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of WEAK onset 25 Jan 2021, WEAK onset 22 Feb 2021, WEAK onset in 2021, ACHES onset 25 Jan 2021, ACHES onset 22 Feb 2021, HEADACHE onset 25 Jan 2021, HEADACHE onset 22 Feb 2021, ACHES onset in 2021 and HEADACHE onset in 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse reaction
Clinical narrative: Had a reaction to COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had a reaction to COVID-19 vaccine) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 30-Jul-2021, the patient experienced ADVERSE REACTION (Had a reaction to COVID-19 vaccine). In 2021, ADVERSE REACTION (Had a reaction to COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication mentioned. No treatment information provided.  Patient took the vaccine on 30JUL2021 and had an adverse reaction to it. Got resolved sometime that year.  Reporters causality for events with Skyrizi was reasonable possibility.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Ill feeling; Generalized aching; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult male 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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), MALAISE (Ill feeling), PAIN (Generalized aching) and FATIGUE (Fatigue). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved, MALAISE (Ill feeling) outcome was unknown and PAIN (Generalized aching) and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Physician discontinued Humira /thought another therapy would work controlling patients pain and rheumatoid arthritis flare ups. 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.  Company Comment: This is a spontaneous case concerning an adult male patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult male patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: 1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021; 1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021; No adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021), COVID-19 IMMUNISATION (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021) and NO ADVERSE EVENT (No adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021), COVID-19 IMMUNISATION (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021) and COVID-19 IMMUNISATION (1st dose of Moderna Vaccine on 20 Feb 2021, then took 2nd shot of the Pfizer Vaccine today 20 Mar 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 47.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue
Clinical narrative: Still had hip pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and ARTHRALGIA (Still had hip pain) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    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 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a week. In 2021, the patient experienced FATIGUE (Tiredness). On an unknown date, the patient experienced ARTHRALGIA (Still had hip pain). In 2021, FATIGUE (Tiredness) had resolved. At the time of the report, ARTHRALGIA (Still had hip pain) had not resolved.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness, Pain, Therapeutic response shortened, Vaccination site pain
Clinical narrative: Pain; Stiffness; Wearing off effect; SORE ARM WHEN TOOK COVID 19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), MUSCULOSKELETAL STIFFNESS (Stiffness), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and VACCINATION SITE PAIN (SORE ARM WHEN TOOK COVID 19 VACCINE) in a 59-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.    Concurrent medical conditions included Psoriatic arthritis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM WHEN TOOK COVID 19 VACCINE). In September 2021, the patient experienced PAIN (Pain), MUSCULOSKELETAL STIFFNESS (Stiffness) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). In 2021, VACCINATION SITE PAIN (SORE ARM WHEN TOOK COVID 19 VACCINE) had resolved. At the time of the report, PAIN (Pain), MUSCULOSKELETAL STIFFNESS (Stiffness) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) had not resolved.            Concomitant medication was not reported.  Treatment details not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns a female patient aged 59 years with relevant medical history of PSORIATIC ARTHRITIS on Humira reported, who experienced the non-serious unexpected event Therapeutic response shortened, that occurred on an unknown date (Sep 2021) in the context of mRNA-1273 vaccination. Patient also had non serious events of Musculoskeletal stiffness and Pain. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient aged 59 years with relevant medical history of PSORIATIC ARTHRITIS on Humira reported, who experienced the non-serious unexpected event Therapeutic response shortened, that occurred on an unknown date (Sep 2021) in the context of mRNA-1273 vaccination. Patient also had non serious events of Musculoskeletal stiffness and Pain. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives/ allergic reaction to Moderna vaccine with a reaction of hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/ allergic reaction to Moderna vaccine with a reaction of hives) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives/ allergic reaction to Moderna vaccine with a reaction of hives). At the time of the report, URTICARIA (Hives/ allergic reaction to Moderna vaccine with a reaction of hives) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient received the Moderna COVID vaccine series and she had a reaction of hives. patient had said that she would like to knowif the Pfizer COVID vaccine has any Tramadol ingredients in it because she is allergic to that medication.   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: Dry skin, Vaccination site pain
Clinical narrative: Elbows were dry; Muscle soreness at COVID vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Elbows were dry) and VACCINATION SITE PAIN (Muscle soreness at COVID vaccine site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DRY SKIN (Elbows were dry) and VACCINATION SITE PAIN (Muscle soreness at COVID vaccine site). At the time of the report, DRY SKIN (Elbows were dry) had not resolved and VACCINATION SITE PAIN (Muscle soreness at COVID vaccine site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest pain, Contusion, Fall, Injury, Vaccination site pain
Clinical narrative: Bruising of chest; Fall; Injury; Chest pain; Vaccination site pain/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising of chest), FALL (Fall), INJURY (Injury), CHEST PAIN (Chest pain) and VACCINATION SITE PAIN (Vaccination site pain/sore arm) in a 73-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) injection for Rheumatoid arthritis.    The patient's past medical history included Knee replacement (In November 2019, the patient experienced RIGHT KNEE REPLACED.) in November 2021 and Knee replacement (In July 2021, the patient experienced LEFT KNEE REPLACED.) in July 2021. Concurrent medical conditions included Rheumatoid arthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/sore arm). On an unknown date, the patient experienced CONTUSION (Bruising of chest), FALL (Fall), INJURY (Injury) and CHEST PAIN (Chest pain). At the time of the report, CONTUSION (Bruising of chest), FALL (Fall), CHEST PAIN (Chest pain) and VACCINATION SITE PAIN (Vaccination site pain/sore arm) outcome was unknown and INJURY (Injury) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Live significant Follow up
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain, Vaccination site pain
Clinical narrative: Discomfort; General body pain/Hurt all over body; Vaccination site pain/Arm hurt after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), PAIN (General body pain/Hurt all over body) and VACCINATION SITE PAIN (Vaccination site pain/Arm hurt after covid vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced DISCOMFORT (Discomfort), PAIN (General body pain/Hurt all over body) and VACCINATION SITE PAIN (Vaccination site pain/Arm hurt after covid vaccine). At the time of the report, DISCOMFORT (Discomfort) outcome was unknown and PAIN (General body pain/Hurt all over body) and VACCINATION SITE PAIN (Vaccination site pain/Arm hurt after covid vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On unknown dates, the patient experienced hurt all over body after covid vaccine, arm hurt after covid vaccine, discomfort a week before next injection and lack of ffect. On unknown dates, hurt all over body after covid vaccine and arm hurt after covid vaccine resolved. Moderna vaccine 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.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Device issue, Respiratory disorder, Rhinorrhoea
Clinical narrative: Upper respiratory disorder; Nasal mucus increased; COVID-19; Device issue; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (Upper respiratory disorder), RHINORRHOEA (Nasal mucus increased), COVID-19 (COVID-19) and DEVICE ISSUE (Device issue) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK dosage form. On an unknown date, the patient experienced RESPIRATORY DISORDER (Upper respiratory disorder), RHINORRHOEA (Nasal mucus increased), COVID-19 (COVID-19) and DEVICE ISSUE (Device issue). At the time of the report, RESPIRATORY DISORDER (Upper respiratory disorder), RHINORRHOEA (Nasal mucus increased), COVID-19 (COVID-19) and DEVICE ISSUE (Device issue) outcome was unknown.            No concomitant medicine was reported. No medical history was reported. On unknown dates, the patient experienced UPPER RESPIRATORY ISSUES and FELT MORE SNIFFLE LIKE PATIENT HAD COLD.  In May 2021, the patient experienced COVID-19. Causality as per reporter for HUMIRA was 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 No treatment medicine was reported.   Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: Sweating increased; Right arm sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating increased) and PAIN IN EXTREMITY (Right arm sore) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced PAIN IN EXTREMITY (Right arm sore). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating increased). In August 2021, PAIN IN EXTREMITY (Right arm sore) had resolved. At the time of the report, HYPERHIDROSIS (Sweating increased) had not resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna   No concomitant medication was reported.  The patient had noticed since starting on Skyrizi had been feeling more tired than usual and sweat more when he was outside.  In Aug-2021, got first Covid shot. His right arm was sore for a couple days but that was about it.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of right arm sore, body aches and nausea was not provided. The reporter's causality for the events of sweating increased and really tired with Skyrizi (risankizumab) was a reasonable possibility.      Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Live follow-up appended: Event was added, suspect drug information and narrative description was updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination site pain
Clinical narrative: FELT SYMPTOMS FOR COVID/ Suspected COVID-19; SORE ARM ON SECOND SHOT OF COVID VACCINE/ Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (FELT SYMPTOMS FOR COVID/ Suspected COVID-19) and VACCINATION SITE PAIN (SORE ARM ON SECOND SHOT OF COVID VACCINE/ Vaccination site pain) in a 67-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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In March 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM ON SECOND SHOT OF COVID VACCINE/ Vaccination site pain). On 04-Oct-2021, the patient experienced SUSPECTED COVID-19 (FELT SYMPTOMS FOR COVID/ Suspected COVID-19). At the time of the report, SUSPECTED COVID-19 (FELT SYMPTOMS FOR COVID/ Suspected COVID-19) and VACCINATION SITE PAIN (SORE ARM ON SECOND SHOT OF COVID VACCINE/ Vaccination site pain) had resolved.            Relevant concomitant medications were not reported.  In Mar-2021, the patient experienced sore arm on second shot of COVID-19 vaccine. On 04-Oct-2021, the patient experienced felt symptoms for COVID-19.  On an unknown date SARS-COV-2 test was performed but the result was not provided.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Patient was" not a vaccine person" but decided to get the covid vaccine anyway and now she doesn't know if she wants to proceed with the second dose which is scheduled for April 22, 2021. also reported that she didn't have any reactions, she had heard feedback from a lot of friends and family who are getting reactions to the second dose and this was causing her to have some hesitation. Patient then clarified that no one she knows got the Pfizer vaccine they got the Moderna.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood glucose, Glucose tolerance impaired, Pain
Clinical narrative: Pre-diabetic; Ache; This spontaneous case was reported by a consumer and describes the occurrence of GLUCOSE TOLERANCE IMPAIRED (Pre-diabetic) and PAIN (Ache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced GLUCOSE TOLERANCE IMPAIRED (Pre-diabetic) and PAIN (Ache). At the time of the report, GLUCOSE TOLERANCE IMPAIRED (Pre-diabetic) outcome was unknown and PAIN (Ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Impaired.         Concomitant medication was not reported.  Patient reported that, the needle was going in with pen and prefers syringe. Patient was diagnosed as pre-diabetic and had ache. Treatment details not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Spinal pain
Clinical narrative: Disc a little tender; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Disc a little tender) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue). On 01-Oct-2021, the patient experienced SPINAL PAIN (Disc a little tender). In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, SPINAL PAIN (Disc a little tender) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Patient experienced fatigue after booster shot. In OCT2021, disc felt a bit tender. It was tested years ago and doctor had said he had a bad disc.   Reporters causality for the events with Rinvoq is no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid Positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid Positive). At the time of the report, COVID-19 (Covid Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Relevant concomitant medications were not reported.  It was reported that patient got COVID-19 positive after double dose of Moderna COVID-19 Vaccine.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a female patient of an unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of the 2 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor 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 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 female patient of an unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of the 2 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor 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 benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: SMALL FLARE UP ON BOTH ELBOWS, MORE ON THE LEFT; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (SMALL FLARE UP ON BOTH ELBOWS, MORE ON THE LEFT) in a 69-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 Hidradenitis suppurativa and Plaque psoriasis.    No Medical History information was reported.   On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced CONDITION AGGRAVATED (SMALL FLARE UP ON BOTH ELBOWS, MORE ON THE LEFT). In 2021, CONDITION AGGRAVATED (SMALL FLARE UP ON BOTH ELBOWS, MORE ON THE LEFT) had resolved.            Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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   The reporter's causality for the event(s) of small flare up on both elbows, more on the left with Humira was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dysgeusia
Clinical narrative: Taste metallic; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste metallic) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DYSGEUSIA (Taste metallic). At the time of the report, DYSGEUSIA (Taste metallic) outcome was unknown.            No concomitant medications were reported. Patient had metallic taste in mouth with Humira. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in No treatment information was reported.
Age: 19.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Epistaxis, Pyrexia
Clinical narrative: Fever; Nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeds) and PYREXIA (Fever) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate Free. On 05-Nov-2021, the patient experienced EPISTAXIS (Nose bleeds). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, EPISTAXIS (Nose bleeds) was resolving and PYREXIA (Fever) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  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
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) 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) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Pain in extremity
Clinical narrative: Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.; Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.) and HEADACHE (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   On 01-Apr-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) UNK UNK, total. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. In 2021, the patient experienced HEADACHE (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.). On an unknown date, the patient experienced PAIN IN EXTREMITY (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.). In 2021, PAIN IN EXTREMITY (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.) and HEADACHE (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.) had resolved.            No relevant concomitant medications were reported. On 01-Apr-2021, the patient started taking DUPIXENT (DUPILUMAB) via pre-filled pen, at unknown loading dose followed by 300 mg every other week (QOW) via subcutaneous route. No treatment medication reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622308 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Inappropriate schedule of product administration
Clinical narrative: Ankle Pain; 1ST dose on 12-MAR-2021 and 2nd dose on 20-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1ST dose on 12-MAR-2021 and 2nd dose on 20-APR-2021) and ARTHRALGIA (Ankle Pain) in a 64-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 12-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1ST dose on 12-MAR-2021 and 2nd dose on 20-APR-2021). On an unknown date, the patient experienced ARTHRALGIA (Ankle Pain). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1ST dose on 12-MAR-2021 and 2nd dose on 20-APR-2021) outcome was unknown and ARTHRALGIA (Ankle Pain) was resolving.            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: M
Vaccine: COVID19, UNK
Symptoms: Chills, Pyrexia, Unevaluable event
Clinical narrative: CONGESTION; FEVER; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (CONGESTION), PYREXIA (FEVER) and CHILLS (CHILLS) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced UNEVALUABLE EVENT (CONGESTION), PYREXIA (FEVER) and CHILLS (CHILLS). At the time of the report, UNEVALUABLE EVENT (CONGESTION), PYREXIA (FEVER) and CHILLS (CHILLS) was resolving.            Concomitant medication was not reported.  In 2021, Body temperature: result not provided. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Sore arm from vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm from vaccination) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-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 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm from vaccination). In 2021, VACCINATION SITE PAIN (Sore arm from vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       IT was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-631387 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Somnolence
Clinical narrative: feels a little groggy; his right arm is achy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (feels a little groggy) and PAIN IN EXTREMITY (his right arm is achy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   On 01-Apr-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) UNK, Total. In 2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced SOMNOLENCE (feels a little groggy) and PAIN IN EXTREMITY (his right arm is achy). At the time of the report, SOMNOLENCE (feels a little groggy) and PAIN IN EXTREMITY (his right arm is achy) had not resolved.            No relevant concomitant medications were reported. On 01-Apr-2021, the patient started taking DUPIXENT (DUPILUMAB) via pre-filled pen, at unknown loading dose followed by 300 mg every other week (QOW) via subcutaneous route. No treatment medication reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622284.