chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: Pain; Stiffness; Fatigue; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PAIN (Pain), MUSCULOSKELETAL STIFFNESS (Stiffness) and FATIGUE (Fatigue) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form once a week. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form once a week. In January 2021, the patient experienced ASTHENIA (Weakness) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (Stiffness). In 2021, ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (Stiffness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant products reported.  No treatment products reported.  The reporter's causality for the event(s) of WEAKNESS AND FATIGUE WITH FIRST COVID VACCINE onset in 2021, WEAKNESS AND FATIGUE WITH FIRST COVID VACCINE onset in 2021 and PAIN was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-620709.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Live follow up received on 14-Apr-2022 included significant information received. updated patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. The event of "STIFFNESS" was added.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inflammation
Clinical narrative: Condition aggravated; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated) and INFLAMMATION (Inflammation) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated) and INFLAMMATION (Inflammation). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) and INFLAMMATION (Inflammation) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant drugs taken.  On unknown dates, the patient experienced body was not responding to humira/humira was not working, flares and inflammation. Moderna covid-19 vaccine (elasomeran) was also considered suspect.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  Patient had no known allergies.  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.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Significant follow up appended. Outcome of event drug ineffective was updated, Event verbatim updated, Action taken and de-challenge for co-suspect updated, Narrative updated
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Herpes zoster, Influenza like illness
Clinical narrative: Shingles; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 20-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 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) was resolving and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the event of Shingles and Flu like symptoms 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. No treatment medicine were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: D DIMER TEST CLIMBING; BLOOD CLOTTING TEST CLIMBING; This spontaneous case was reported by a consumer and describes the occurrence of FIBRIN D DIMER INCREASED (D DIMER TEST CLIMBING) and BLOOD TEST ABNORMAL (BLOOD CLOTTING TEST CLIMBING) in an adult 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 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced FIBRIN D DIMER INCREASED (D DIMER TEST CLIMBING) and BLOOD TEST ABNORMAL (BLOOD CLOTTING TEST CLIMBING). At the time of the report, FIBRIN D DIMER INCREASED (D DIMER TEST CLIMBING) and BLOOD TEST ABNORMAL (BLOOD CLOTTING TEST CLIMBING) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2022, Fibrin D dimer: 893 893. On an unknown date, Blood test: climbing. On an unknown date, Fibrin D dimer: 147 147, 563 563 and 827 827.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. On unknown dates, the patient experienced D DIMER TEST CLIMBING and BLOOD CLOTTING TEST CLIMBING. Blood test, blood clotting test started climbing and patient dicontinued Rinvoq. in Dec 2021. She states that it may have been vaccine that caused D Dimer was 147 that climbed to 563, then 827 and it was checked on 21 Jan 2022 and it was 893.  No treatment medication was reported. Her doctor took her off of this medication as a precaution. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of D DIMER TEST CLIMBING and BLOOD CLOTTING TEST CLIMBING with RINVOQ(UPADACITINIB) 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Malaise
Clinical narrative: Stomach issues/upset stomach; Did not feel good; Headache/head hurts; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues/upset stomach), MALAISE (Did not feel good) and HEADACHE (Headache/head hurts) in a 55-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 an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose: CF, Solution for injection in pre-filled pen. On 09-Mar-2022, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues/upset stomach), MALAISE (Did not feel good) and HEADACHE (Headache/head hurts). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues/upset stomach) and HEADACHE (Headache/head hurts) had not resolved and MALAISE (Did not feel good) outcome was unknown.            Concomitant Drugs were not reported.  Treatment medications were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Bronchitis, Pain in extremity, Peripheral swelling
Clinical narrative: Bronchitis; Asthmatic attack; Swelling in legs; pain in legs; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), ASTHMA (Asthmatic attack), PERIPHERAL SWELLING (Swelling in legs) and PAIN IN EXTREMITY (pain in legs) 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) solution for injection for Ulcerative colitis and Crohn's disease.    Concurrent medical conditions included Ulcerative colitis (moderate to severe) and Crohn's disease (moderate to severe adult crohn's disease).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced BRONCHITIS (Bronchitis), ASTHMA (Asthmatic attack), PERIPHERAL SWELLING (Swelling in legs) and PAIN IN EXTREMITY (pain in legs). At the time of the report, BRONCHITIS (Bronchitis), ASTHMA (Asthmatic attack) and PERIPHERAL SWELLING (Swelling in legs) was resolving and PAIN IN EXTREMITY (pain in legs) outcome was unknown.        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.  The reporter's Causality for Humira(adalimumab) for the event(s) of bronchitis, asthma attack, swelling in legs and pain in legs was not provided.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Sinusitis
Clinical narrative: Diagnosed with COVID-19 in the end of Dec-2021/ COVID-19; Patient had about four or five sinus infections/ Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19 in the end of Dec-2021/ COVID-19) and SINUSITIS (Patient had about four or five sinus infections/ Sinus infection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced COVID-19 (Diagnosed with COVID-19 in the end of Dec-2021/ COVID-19) and SINUSITIS (Patient had about four or five sinus infections/ Sinus infection). At the time of the report, COVID-19 (Diagnosed with COVID-19 in the end of Dec-2021/ COVID-19) had resolved and SINUSITIS (Patient had about four or five sinus infections/ Sinus infection) outcome was unknown.            Relevant concomitant medications were not reported.  In Dec-2021, the patient received booster dose of Moderna COVID-19 Vaccine.  The patient had about four or five sinus infections since starting Rinvoq in Dec-2021. She stated that she was getting one about every four weeks. She was diagnosed with COVID-19 in the end of Dec-2021. She got it about two weeks after getting her Moderna COVID-19 Booster shot.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  Reporter's causality for the event of sinus infections and COVID-19 with RINVOQ 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: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive.         Concomitant medications included vitamins. Patient stated that she was taking Paxlovid for a couple of days and would like to know if Paxlovid interacts with the vitamins patient was taking. Patient wanted to know if vitamins were contraindicated with Paxlovid. Patient was scheduled to get a second booster. Patient wanted to know that can she get second booster, after being positive for COVID-19 and taking Paxlovid. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol, Blood test
Clinical narrative: JOINTS WERE ACHY AFTER VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (JOINTS WERE ACHY AFTER VACCINATION) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (JOINTS WERE ACHY AFTER VACCINATION). At the time of the report, ARTHRALGIA (JOINTS WERE ACHY AFTER VACCINATION) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: heightened cholesterol. On an unknown date, Blood test: Unknown.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. On unknown dates, the patient experienced JOINTS WERE ACHY AFTER VACCINATION and HEIGHTENED CHOLESTEROL. On an unknown date, JOINTS WERE ACHY AFTER VACCINATION resolved.  The patient had heightened cholesterol due to other medication prescribed by Health care professional. She was waiting for bloodwork by health care professional. Her joints were achy after vaccination. It was possible side effect according to her, she was not sure. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of JOINTS WERE ACHY AFTER VACCINATION and HEIGHTENED CHOLESTEROL with RINVOQ(UPADACITINIB) 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Limb mass, Pyrexia, Swelling, Weight increased
Clinical narrative: Weight gain; Allergic reaction; Limb mass; Swelling; Fever; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), LIMB MASS (Limb mass), SWELLING (Swelling), PYREXIA (Fever) and HYPERSENSITIVITY (Allergic reaction) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-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) 1 dosage form. On 15-Feb-2022, the patient experienced HYPERSENSITIVITY (Allergic reaction). In February 2022, the patient experienced LIMB MASS (Limb mass), SWELLING (Swelling) and PYREXIA (Fever). On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain). At the time of the report, WEIGHT INCREASED (Weight gain), LIMB MASS (Limb mass), SWELLING (Swelling) and PYREXIA (Fever) outcome was unknown and HYPERSENSITIVITY (Allergic reaction) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products reported.  No treatment products reported.  The reporter's causality for the event(s) of WEIGHT GAIN, LUMP ON ARM, SWELLING and FEVER was not provided.  The reporter's causality for the event(s) of ALLERGIC REACTION TO MODERNA BOOSTER VACCINATION with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-624698 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Significant follow- up received included updated event information, reporter opinion of causality, suspect drug information and narrative description. The events of "LUMP ON ARM", "SWELLING" and "FEVER" were added.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Device issue, Swelling
Clinical narrative: Spondylitis ankylosing aggravated; Device issue; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 46-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 Rheumatoid arthritis aggravated.    The patient's past medical history included Ankylosing spondylitis and Rheumatoid arthritis.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant), DEVICE ISSUE (Device issue) and SWELLING (Swelling). At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) had not resolved and DEVICE ISSUE (Device issue) and SWELLING (Swelling) outcome was unknown.            Tried licked it because patient did not want to lose it and needle of pen never came out.   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.  Company comment: This spontaneous case concerns a 46-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) events of ankylosing spondylitis  an unknown time after the first and second dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Follow up document contain suspect drug information and narrative description were reported.; Sender's Comments: This spontaneous case concerns a 46-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) events of ankylosing spondylitisan unknown time after the first and second dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had not resolved.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  No concomitant medication information was reported. No treatment medication information was reported. The patient stated that after five hours of taking Rinvoq the pain kicks back and not lasted as long as used to after taking COVID-19 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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Joint stiffness, Vaccination site pain
Clinical narrative: Balance disorder; Joint stiffness; Pain in joint; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Balance disorder), JOINT STIFFNESS (Joint stiffness), ARTHRALGIA (Pain in joint) and VACCINATION SITE PAIN (Vaccination site pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HYALURONATE SODIUM (HUMIA) for an unknown indication.    No Medical History information was reported.   On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started HYALURONATE SODIUM (HUMIA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder), JOINT STIFFNESS (Joint stiffness), ARTHRALGIA (Pain in joint) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, BALANCE DISORDER (Balance disorder), JOINT STIFFNESS (Joint stiffness) and ARTHRALGIA (Pain in joint) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported  The reporter's causality for the event(s) of BALANCE ISSUE, PAIN IN JOINT and JOINT STIFFNESS was not provided.   The reporter's causality for the event(s) of PAIN IN ARM AFTER COVID VACCINE WENT UP TO SHOULDER with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Pulmonary oedema
Clinical narrative: fluid in lungs after booster; memory was not good; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (fluid in lungs after booster) in a female patient of an unknown age 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE ).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PULMONARY OEDEMA (fluid in lungs after booster) (seriousness criterion medically significant) and MEMORY IMPAIRMENT (memory was not good). At the time of the report, PULMONARY OEDEMA (fluid in lungs after booster) and MEMORY IMPAIRMENT (memory was not good) outcome was unknown.            No concomitant medication was provided. Treatment medication was not provided by the reporter.  Patient stated that she was getting old but it seems like memory was not good. Her physician was doing some additional testing.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for SKYRIZI for the event(s) of fluid in lungs after booster and memory was not good 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 concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of Pulmonary oedema (fluid in lungs), after receiving a booster 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 outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of Pulmonary oedema (fluid in lungs), after receiving a booster 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 outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Bone density abnormal, Pain, Vaccination site pain
Clinical narrative: Pain; Bone density abnormal/BONE DENSITY TEST WAS NOT GOOD; Vaccination site pain/ SORE ARM AFTER EACH COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), BONE DENSITY ABNORMAL (Bone density abnormal/BONE DENSITY TEST WAS NOT GOOD) and VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AFTER EACH COVID VACCINE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), BONE DENSITY ABNORMAL (Bone density abnormal/BONE DENSITY TEST WAS NOT GOOD) and VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AFTER EACH COVID VACCINE). At the time of the report, PAIN (Pain), BONE DENSITY ABNORMAL (Bone density abnormal/BONE DENSITY TEST WAS NOT GOOD) and VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AFTER EACH COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Unknown date: Bone density test was performed and result was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching in general; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in general) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection 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 February 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 PRURITUS (itching in general). At the time of the report, PRURITUS (itching in general) 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: INFLAMMATION ON NECK,SHOULDERS,THIGHS AND ARMS; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (INFLAMMATION ON NECK,SHOULDERS,THIGHS AND ARMS) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Venous insufficiency since 2011, Rheumatoid arthritis and Deep vein thrombosis.   On 10-Jun-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient experienced INFLAMMATION (INFLAMMATION ON NECK,SHOULDERS,THIGHS AND ARMS). At the time of the report, INFLAMMATION (INFLAMMATION ON NECK,SHOULDERS,THIGHS AND ARMS) had resolved. Not Provided          No relevant concomitant medications were reported.   The reporter's causality for the event of inflammation on neck, shoulders, thighs and arms with humira 40mg/0.4ml(adalimumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter did not have the lot number information, because the packaging was discarded.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, COVID-19, SARS-CoV-2 test
Clinical narrative: Allergy to vaccine; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and ALLERGY TO VACCINE (Allergy to vaccine) 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) solution for injection for Rheumatoid arthritis.    There was no reported medical history.    On an unknown date, the patient received second 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. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 24-Jan-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine). At the time of the report, COVID-19 (COVID-19) had not resolved and ALLERGY TO VACCINE (Allergy to vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, SARS-CoV-2 test: (Positive) Positive.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Injection site itching; Injection site welt; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE URTICARIA (Injection site welt) in a 69-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 27-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE URTICARIA (Injection site welt). At the time of the report, INJECTION SITE PRURITUS (Injection site itching) outcome was unknown and INJECTION SITE URTICARIA (Injection site welt) was resolving.            No concomitant product was reported. 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 25-Feb-2021 and second dose on 01-Jul-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25-Feb-2021 and second dose on 01-Jul-2021) and NO ADVERSE EVENT (No adverse event) in a 77-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.    No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On 01-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25-Feb-2021 and second dose on 01-Jul-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). The patient was treated with BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) at a dose of Unknown and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) at a dose of Unknown. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25-Feb-2021 and second dose on 01-Jul-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient had no known allergy.  No concomitant drugs were taken by patient.  Primary reporter contact for lot number information was not available.  Causality for Humira (solution for injection in pre-filled syringe): the reporter's causality for the event(s) of diabetic, asthma was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.   This case was linked to MOD-2022-620189 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Infrequent bowel movements, Vaccination site pain
Clinical narrative: Infrequent bowel movements/Less frequent bowel movements; Diarrhea; Vaccination site pain/vaccines caused to had sore arm; Tiredness/little tired; This spontaneous case was reported by a consumer and describes the occurrence of INFREQUENT BOWEL MOVEMENTS (Infrequent bowel movements/Less frequent bowel movements), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain/vaccines caused to had sore arm) and FATIGUE (Tiredness/little tired) 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) solution for injection for an unknown indication.    No Medical History information was reported.   In December 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Dose increased. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free (1 in 1 wk). On an unknown date, the patient experienced INFREQUENT BOWEL MOVEMENTS (Infrequent bowel movements/Less frequent bowel movements), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain/vaccines caused to had sore arm) and FATIGUE (Tiredness/little tired). At the time of the report, INFREQUENT BOWEL MOVEMENTS (Infrequent bowel movements/Less frequent bowel movements), VACCINATION SITE PAIN (Vaccination site pain/vaccines caused to had sore arm) and FATIGUE (Tiredness/little tired) outcome was unknown and DIARRHOEA (Diarrhea) had not 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 less frequent bowel movements, diarrhea and vaccines caused to had sore arm and be a little tired.  No treatment details reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Action taken with Co-suspect Humira was reported as Dose increased.  The reporter's causality for Humira (adalimumab) with response to the event less frequent bowel movements was not provided. The reporter's causality for the event(s) of diarrhea with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of vaccines caused to had sore arm and be a little tired unknown onset and vaccines caused to had sore arm and be a little tired unknown onset with humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Peripheral swelling, Rash pruritic, Vomiting
Clinical narrative: SWELLING AND  ITCHY RASH IN LEFT ARM FROM DELTOID TO WRIST; Diarrhea; NODE UNDER LEFT ARMPIT SWELLING and VOMITING; Itchy rash; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (SWELLING AND  ITCHY RASH IN LEFT ARM FROM DELTOID TO WRIST), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (NODE UNDER LEFT ARMPIT SWELLING and VOMITING), RASH PRURITIC (Itchy rash) and 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) for Chronic lymphoid leukemia.    No Medical History information was reported.   On 10-May-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. In September 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 received first 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. On an unknown date, the patient experienced PERIPHERAL SWELLING (SWELLING AND  ITCHY RASH IN LEFT ARM FROM DELTOID TO WRIST), DIARRHEA (Diarrhea), LYMPHADENOPATHY (NODE UNDER LEFT ARMPIT SWELLING and VOMITING), RASH PRURITIC (Itchy rash) and VOMITING (Vomiting). At the time of the report, PERIPHERAL SWELLING (SWELLING AND  ITCHY RASH IN LEFT ARM FROM DELTOID TO WRIST) and RASH PRURITIC (Itchy rash) had not resolved and DIARRHEA (Diarrhea), LYMPHADENOPATHY (NODE UNDER LEFT ARMPIT SWELLING and VOMITING) and VOMITING (Vomiting) had resolved.            Concomitant product use was not provided by the reporter. On unknown dates, the patient experienced diarrhea, swelling and itchy rash in left arm from deltoid to wrist, node under left armpit swelling and vomiting. 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.   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Immunisation reaction, Pruritus
Clinical narrative: itch; diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso; red spot on her right leg; a reaction to the moderna vaccine; rash; headache; tiredness; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch), PSORIASIS (diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso), ERYTHEMA (red spot on her right leg), IMMUNISATION REACTION (a reaction to the moderna vaccine) and RASH (rash) in an 83-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Asthma.    Concurrent medical conditions included Asthma.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) administered at loading dose of 600 mg once followed by 300 mg every other week. On an unknown date, the patient experienced PRURITUS (itch), PSORIASIS (diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso), ERYTHEMA (red spot on her right leg), IMMUNISATION REACTION (a reaction to the moderna vaccine), RASH (rash), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PRURITUS (itch), PSORIASIS (diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso), ERYTHEMA (red spot on her right leg), IMMUNISATION REACTION (a reaction to the moderna vaccine), RASH (rash), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that dupilumab administered at loading dose of 600 mg once followed by 300 mg every other week for asthma  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.