chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: after the 1st one that they all felt really bad like they all had flu after they had the vaccine; after the 1st one that they all felt really bad like they all had flu after they had the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) 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, the patient experienced FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (after the 1st one that they all felt really bad like they all had flu after they had the vaccine). At the time of the report, FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that after the first one they all felt really bad like they had the flu after they had the vaccine. Patient had flu like issues. 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: Feeling abnormal, Influenza like illness
Clinical narrative: after the 1st one that they all felt really bad like they all had flu after they had the vaccine; had flu like issues; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (had flu like issues) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (had flu like issues). At the time of the report, FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (had flu like issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that after the first one they all felt really bad like they had the flu after they had the vaccine. Patient had flu like issues. 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: Immunisation reaction
Clinical narrative: her husband was "wiped out"after the Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (her husband was "wiped out"after the Moderna vaccine.) 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 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 (her husband was "wiped out"after the Moderna vaccine.). At the time of the report, IMMUNISATION REACTION (her husband was "wiped out"after the Moderna vaccine.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. 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-2021-288308, MOD-2021-288281 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose was administered Dec-2020 and second dose was administered on Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered Dec-2020 and second dose was administered on Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   In December 2020, 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. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered Dec-2020 and second dose was administered on Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered Dec-2020 and second dose was administered on Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Blood test: increased Sedimentation rate..         Concomitant product use was not provided by the reporter.  On 28-Oct-2021, blood work showed increased sedimentation rate. On 28 Oct 2021 she had taken flu shot. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623528, MOD-2021-628642 (Patient Link).   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick the first day after each covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick the first day after each covid vaccine) in a 76-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 Ankylosing spondylitis and Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis and Ankylosing spondylitis.   On 02-Oct-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre filled syringe. On 03-Oct-2020, the patient experienced ILLNESS (Got sick the first day after each covid vaccine). At the time of the report, ILLNESS (Got sick the first day after each covid vaccine) had not 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 mailbox were missed to be booked-in.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Eye inflammation, Eyelid scar
Clinical narrative: Eye inflammation; Eyelid scar; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (Eye inflammation), EYELID SCAR (Eyelid scar) and BACK PAIN (Back pain) in a 76-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced EYE INFLAMMATION (Eye inflammation), EYELID SCAR (Eyelid scar) and BACK PAIN (Back pain). At the time of the report, EYE INFLAMMATION (Eye inflammation) and EYELID SCAR (Eyelid scar) had resolved and BACK PAIN (Back pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Abnormal.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided.  On unknown date, the patient experienced scaring in eye but inflamation went down, still on blood pressure and back pain. On an unknown date, scaring in eye but inflamation went down resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of scaring in eye but inflamation went down unknown onset with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the events of scaring in eye but inflamation went down unknown onset, still on blood pressure and back 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Herpes zoster, Ulcer
Clinical narrative: Ulcerations; Shingles affecting inguinal area; Abdominal pain; Watery stools; This spontaneous case was reported by a consumer and describes the occurrence of ULCER (Ulcerations), HERPES ZOSTER (Shingles affecting inguinal area), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Watery stools) 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.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ULCER (Ulcerations), HERPES ZOSTER (Shingles affecting inguinal area), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Watery stools). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, ULCER (Ulcerations) was resolving, HERPES ZOSTER (Shingles affecting inguinal area) had resolved and ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Watery stools) outcome was unknown.            No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event of ulcerations and shingles affecting inguinal area with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of abdominal pain and watery stools was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) had resolved.            Relevant concomitant medications were not reported.  On an unknown date, patient experienced vomiting and it got resolved.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality for the event of vomiting with HUMIRA 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: Condition aggravated
Clinical narrative: Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis and Psoriatic arthritis.   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). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Formulation of Humira was reported as Solution for injection in pre-filled pen.  On an unknown date patient experienced flare ups.  Reporters causality of events with Humira was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Illness, Infectious mononucleosis, Stress
Clinical narrative: Anxiety; Lot of stress; Sick/felt like had mono after COVID vaccine; Sick/felt like had mono after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), STRESS (Lot of stress), INFECTIOUS MONONUCLEOSIS (Sick/felt like had mono after COVID vaccine) and ILLNESS (Sick/felt like had mono after COVID vaccine) in a 56-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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe hidradenitis suppurativa).   In September 2021, the patient 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 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) 1 dosage form. In September 2021, the patient experienced INFECTIOUS MONONUCLEOSIS (Sick/felt like had mono after COVID vaccine) and ILLNESS (Sick/felt like had mono after COVID vaccine). On an unknown date, the patient experienced ANXIETY (Anxiety) and STRESS (Lot of stress). At the time of the report, ANXIETY (Anxiety) and STRESS (Lot of stress) had not resolved and INFECTIOUS MONONUCLEOSIS (Sick/felt like had mono after COVID vaccine) and ILLNESS (Sick/felt like had mono after COVID vaccine) had resolved.            No concomitant medication was reported. No treatment medication was reported.  In 2021, the sick/felt like had mono after COVID vaccine resolved.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of sick/felt like had mono after COVID vaccine with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of anxiety and lot of stress was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: PAIN IN RIGHT SIDE OF RIBS; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (PAIN IN RIGHT SIDE OF RIBS) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    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) UNK, Citrate free. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (PAIN IN RIGHT SIDE OF RIBS). At the time of the report, MUSCULOSKELETAL CHEST PAIN (PAIN IN RIGHT SIDE OF RIBS) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of humira as per reporter for event rib pain was no reasonable possibility. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 51-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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In January 2022, the patient experienced COVID-19 (COVID). In 2022, COVID-19 (COVID) had resolved.            No concomitant and treatment information was provided.  The reporter's causality for the event of covid with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  CC: This spontaneous case concerns a 51-year-old, male patient with a concurrent condition of psoriatic arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 the following month after receiving a 3rd dose of mRNA-1273 vaccine. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying psoriatic arthritis and treatment with adalimumab could predispose him to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow-up information included event outcome updated, new dosage regimen and batch number added for Humira suspect.; Sender's Comments: This spontaneous case concerns a 51-year-old, male patient with a concurrent condition of psoriatic arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 the following month after receiving a 3rd dose of mRNA-1273 vaccine. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying psoriatic arthritis and treatment with adalimumab could predispose him to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Influenza like illness, Seasonal allergy, Swelling face
Clinical narrative: Swelling of face; Eyes swollen; Pollen allergy; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of face), (Eyes swollen), (Pollen allergy) and (Flu-like symptoms) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product(RINVOQ) for Rheumatoid arthritis.       On an unknown date, 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 (Flu-like symptoms). On an unknown date, the patient experienced (Swelling of face), (Eyes swollen) and (Pollen allergy). At the time of the report, (Swelling of face) and (Eyes swollen) had not resolved, (Pollen allergy) outcome was unknown and (Flu-like symptoms) had resolved.            The patient had swelling in his face and eyes. Patient said it could be due to allergies from the pollen in the air. Patient was also sick for 2 weeks with flu-like symptoms after having the Moderna Covid booster and flu like symptoms was the only adverse event reported. Although patient never had a fever. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment medications were not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR), AMLODIPINE, MELOXICAM, METHOTREXATE, SULFASALAZINE, ONDANSETRON, VITAMIN D2 and FOLIC ACID for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (chills). At the time of the report, PYREXIA (Fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient had high fever and chills 7-8 hrs after vaccine.  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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Migraine
Clinical narrative: MIGRAINE; NOT FEELING WELL; LACK OF ENERGY; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (MIGRAINE), MALAISE (NOT FEELING WELL) and ASTHENIA (LACK OF ENERGY) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Migraine.   On 01-Dec-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 01-Dec-2021, the patient experienced MALAISE (NOT FEELING WELL). 01-Dec-2021, the patient experienced ASTHENIA (LACK OF ENERGY). On an unknown date, the patient experienced MIGRAINE (MIGRAINE). At the time of the report, MIGRAINE (MIGRAINE) and MALAISE (NOT FEELING WELL) outcome was unknown and ASTHENIA (LACK OF ENERGY) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO KNOWN ALLERGIES. No concomitant medication was reported. On an unknown date, the patient experienced MIGRAINE. On 01 Dec 2021, the patient experienced NOT FEELING WELL and LACK OF ENERGY. On an unknown date, LACK OF ENERGY resolved. Patient had migraines all her life. Patient didn't felt well after covid vaccine and felt lack of energy. Also had a migraine was not sure if vaccine or her normal migraine. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of MIGRAINE and NOT FEELING WELL was not provided. The reporter's causality for the event(s) of LACK OF ENERGY with SKYRIZI(RISANKIZUMAB) 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Increased tendency to bruise, Vaccination site bruising, Vaccination site pruritus
Clinical narrative: bruises easily; COVID booster vaccine caused itchiness and bruising; COVID booster vaccine caused itchiness and bruising; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED TENDENCY TO BRUISE (bruises easily), VACCINATION SITE BRUISING (COVID booster vaccine caused itchiness and bruising) and VACCINATION SITE PRURITUS (COVID booster vaccine caused itchiness and bruising) in a 60-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]) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. In December 2021, the patient experienced VACCINATION SITE BRUISING (COVID booster vaccine caused itchiness and bruising) and VACCINATION SITE PRURITUS (COVID booster vaccine caused itchiness and bruising). On an unknown date, the patient experienced INCREASED TENDENCY TO BRUISE (bruises easily). At the time of the report, INCREASED TENDENCY TO BRUISE (bruises easily), VACCINATION SITE BRUISING (COVID booster vaccine caused itchiness and bruising) and VACCINATION SITE PRURITUS (COVID booster vaccine caused itchiness and bruising) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 21-Jan-2022, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment details were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperkeratosis, Malaise, Pruritus
Clinical narrative: Calluses on bottom of feet; Did not feel good; Bottom of legs got itchy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERKERATOSIS (Calluses on bottom of feet), MALAISE (Did not feel good) and PRURITUS (Bottom of legs got itchy) in a 39-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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In 2021, the patient experienced HYPERKERATOSIS (Calluses on bottom of feet), MALAISE (Did not feel good) and PRURITUS (Bottom of legs got itchy). At the time of the report, HYPERKERATOSIS (Calluses on bottom of feet), MALAISE (Did not feel good) and PRURITUS (Bottom of legs got itchy) was resolving.     Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of calluses on bottom of feet, did not feel good and bottom of legs got itchy with Humira (Adalimumab) was no reasonable possibility.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Muscle spasms, Nasopharyngitis, Pain
Clinical narrative: COVID-19 VACCINATION MADE FELT ACHY ALL OVER; Sniffles; Postnasal drip; COVID-19; Cold like symptoms; Muscle spasm in chest; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (COVID-19 VACCINATION MADE FELT ACHY ALL OVER), RHINORRHOEA (Sniffles), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold like symptoms) in an adult 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 Plaque psoriasis.    No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (COVID-19 VACCINATION MADE FELT ACHY ALL OVER), RHINORRHOEA (Sniffles), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), COVID-19 (COVID-19), NASOPHARYNGITIS (Cold like symptoms), MUSCLE SPASMS (Muscle spasm in chest) and FATIGUE (TIRED). At the time of the report, PAIN (COVID-19 VACCINATION MADE FELT ACHY ALL OVER), RHINORRHOEA (Sniffles), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), COVID-19 (COVID-19), NASOPHARYNGITIS (Cold like symptoms), MUSCLE SPASMS (Muscle spasm in chest) and FATIGUE (TIRED) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter. On unknown dates, the patient experienced sniffles, covid-19 vaccination made felt achy all over and tired, postnasal drip, covid-19, cold like symptoms and muscle spasm in chest. No treatment information was provided. The reporter's causality of Humira for the events PAIN, RHINORRHOEA, UPPER-AIRWAY COUGH SYNDROME, COVID-19, NASOPHARYNGITIS, MUSCLE SPASMS and FATIGUE 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Live follow up received: New event added.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Upper-airway cough syndrome
Clinical narrative: COVID-19 VACCINATION MADE FELT ACHY ALL OVER; Sniffles; Postnasal drip; COVID-19; Cold like symptoms; Muscle spasm in chest; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (COVID-19 VACCINATION MADE FELT ACHY ALL OVER), RHINORRHOEA (Sniffles), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold like symptoms) in an adult 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 Plaque psoriasis.    No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (COVID-19 VACCINATION MADE FELT ACHY ALL OVER), RHINORRHOEA (Sniffles), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), COVID-19 (COVID-19), NASOPHARYNGITIS (Cold like symptoms), MUSCLE SPASMS (Muscle spasm in chest) and FATIGUE (TIRED). At the time of the report, PAIN (COVID-19 VACCINATION MADE FELT ACHY ALL OVER), RHINORRHOEA (Sniffles), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), COVID-19 (COVID-19), NASOPHARYNGITIS (Cold like symptoms), MUSCLE SPASMS (Muscle spasm in chest) and FATIGUE (TIRED) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter. On unknown dates, the patient experienced sniffles, covid-19 vaccination made felt achy all over and tired, postnasal drip, covid-19, cold like symptoms and muscle spasm in chest. No treatment information was provided. The reporter's causality of Humira for the events PAIN, RHINORRHOEA, UPPER-AIRWAY COUGH SYNDROME, COVID-19, NASOPHARYNGITIS, MUSCLE SPASMS and FATIGUE 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Live follow up received: New event added.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Therapeutic response decreased
Clinical narrative: Have never missed my dupixent shot but it doesn't help it at all; Head to toe with dermatitis; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE DECREASED (Have never missed my dupixent shot but it doesn't help it at all) and DERMATITIS (Head to toe with dermatitis) 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 DUPILUMAB (DUPIXENT) for an unknown indication.    No Medical History information was reported.   In 2017, the patient started DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. On 01-Aug-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 THERAPEUTIC RESPONSE DECREASED (Have never missed my dupixent shot but it doesn't help it at all) and DERMATITIS (Head to toe with dermatitis). At the time of the report, THERAPEUTIC RESPONSE DECREASED (Have never missed my dupixent shot but it doesn't help it at all) outcome was unknown and DERMATITIS (Head to toe with dermatitis) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Dupixent was administered via dupixent singledose pre-filled pen. Dupixent worked so well for the patient. Patient was put on 3 rounds of steroids which helped as long as was on it. 2 days off of the steroids and symptoms were right back. It was not reported if the patient received a corrective treatment for the events (head to toe with dermatitis, have never missed my Dupixent shot but it doesn't help it at all). No concomitant medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle spasms, Pain assessment, Weight
Clinical narrative: Weight gain; Muscle cramps; Tiredness; Arthritic pains; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), MUSCLE SPASMS (Muscle cramps), FATIGUE (Tiredness) and ARTHRALGIA (Arthritic pains) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) 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) unknown. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), MUSCLE SPASMS (Muscle cramps), FATIGUE (Tiredness) and ARTHRALGIA (Arthritic pains). At the time of the report, WEIGHT INCREASED (Weight gain), MUSCLE SPASMS (Muscle cramps) and FATIGUE (Tiredness) had not resolved and ARTHRALGIA (Arthritic pains) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: Three. On an unknown date, Weight: gain 25 Pounds.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No information on concomitant medication were reported. The patient had experienced weight gain 25 pound since beginning Rinvoq. She had felt tired most of the time and also having muscle cramps since beginning Rinvoq. But it had been able to manage them by taking an over the counter magnesium product. Her rheumatoid arthritis pain had primarily subsided but has occasional pain. She rated this pain at a three. 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 WEIGHT GAIN, TIRED and MUSCLE CRAMPS with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the event(s) of OCCASIONAL RHEUMATOID ARTHRITIS PAIN 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
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Weight gain; Muscle cramps; Tiredness; Arthritic pains; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), MUSCLE SPASMS (Muscle cramps), FATIGUE (Tiredness) and ARTHRALGIA (Arthritic pains) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) 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) unknown. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), MUSCLE SPASMS (Muscle cramps), FATIGUE (Tiredness) and ARTHRALGIA (Arthritic pains). At the time of the report, WEIGHT INCREASED (Weight gain), MUSCLE SPASMS (Muscle cramps) and FATIGUE (Tiredness) had not resolved and ARTHRALGIA (Arthritic pains) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: Three. On an unknown date, Weight: gain 25 Pounds.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No information on concomitant medication were reported. The patient had experienced weight gain 25 pound since beginning Rinvoq. She had felt tired most of the time and also having muscle cramps since beginning Rinvoq. But it had been able to manage them by taking an over the counter magnesium product. Her rheumatoid arthritis pain had primarily subsided but has occasional pain. She rated this pain at a three. 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 WEIGHT GAIN, TIRED and MUSCLE CRAMPS with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the event(s) of OCCASIONAL RHEUMATOID ARTHRITIS PAIN 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: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia
Clinical narrative: anemia; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (anemia) in a 29-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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, the patient experienced ANAEMIA (anemia). At the time of the report, ANAEMIA (anemia) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  It was reported that the patient now can't get kids anymore.  No treatment medication was reported.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Live Follow-up: No new information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: Appetite lost/loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost/loss of appetite) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    There was no reported medical history.    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 DECREASED APPETITE (Appetite lost/loss of appetite). At the time of the report, DECREASED APPETITE (Appetite lost/loss of appetite) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Formulation for HUMIRA was given as Solution for injection in pre-filled pen.  The reporter's causality with HUMIRA for the event of decreased appetite 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
Symptoms: Ligament sprain, Nausea, Skin discolouration
Clinical narrative: In between toes had a little discoloration; Sprained ankle; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (In between toes had a little discoloration), LIGAMENT SPRAIN (Sprained ankle) and NAUSEA (Nausea) 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 an unknown indication.    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 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SKIN DISCOLOURATION (In between toes had a little discoloration), LIGAMENT SPRAIN (Sprained ankle) and NAUSEA (Nausea). At the time of the report, SKIN DISCOLOURATION (In between toes had a little discoloration) outcome was unknown, LIGAMENT SPRAIN (Sprained ankle) was resolving and NAUSEA (Nausea) had resolved.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.