chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Myocarditis, Thrombosis
Clinical narrative: Guillain-Barre disease; myocarditis; blood clots; This spontaneous case was reported by an other health care professional and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre disease), MYOCARDITIS (myocarditis) and THROMBOSIS (blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre disease) (seriousness criteria hospitalization and medically significant), MYOCARDITIS (myocarditis) (seriousness criterion medically significant) and THROMBOSIS (blood clots) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre disease), MYOCARDITIS (myocarditis) and THROMBOSIS (blood clots) 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 medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected serious (medically significant) AESI events of Myocarditis  and Thrombosis  and unexpected serious (hospitalization and medically significant) AESI event of  Guillain-Barre syndrome which occurred on an unknown date in context to a  dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the events outcome was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected serious (medically significant) AESI events of Myocarditis  and Thrombosis  and unexpected serious (hospitalization and medically significant) AESI event of  Guillain-Barre syndrome which occurred on an unknown date in context to a  dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the events outcome was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising
Clinical narrative: BRUISE AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (BRUISE AT INJECTION SITE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Plaque psoriasis.    No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE BRUISING (BRUISE AT INJECTION SITE). At the time of the report, INJECTION SITE BRUISING (BRUISE AT INJECTION SITE) had resolved.            No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received Humira as Solution for injection in pre-filled pen.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Have killed and injured millions of people, including me; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Have killed and injured millions of people, including me) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Have killed and injured millions of people, including me). At the time of the report, IMMUNISATION REACTION (Have killed and injured millions of people, including me) 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.  The patient was experienced adverse event due to Moderna and Pfizer COVID-19 vaccine.  No treatment medication was reported.
Age: 34.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colonoscopy, Headache, Impaired healing, Ulcer
Clinical narrative: BAD HEADACHE; NON HEALING ULCER; NON HEALING ULCER; This spontaneous case was reported by a consumer and describes the occurrence of ULCER (NON HEALING ULCER), IMPAIRED HEALING (NON HEALING ULCER) and HEADACHE (BAD HEADACHE) in a 34-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 Crohn's disease.    No Medical History information was reported.   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, Solution for injection in pre-filled pen. In September 2021, the patient experienced ULCER (NON HEALING ULCER) and IMPAIRED HEALING (NON HEALING ULCER). On an unknown date, the patient experienced HEADACHE (BAD HEADACHE). At the time of the report, ULCER (NON HEALING ULCER) and IMPAIRED HEALING (NON HEALING ULCER) was resolving and HEADACHE (BAD HEADACHE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Colonoscopy: COLONOSCOPY: Ulcer.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No concomitant medication were reported.  The reporters causality for the events of NON HEALING ULCER onset in September 2021 with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of BAD HEADACHE and NON HEALING ULCER onset in September 2021 was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Immunisation reaction, Inflammation, Rheumatoid factor quantitative, Scan
Clinical narrative: Blood work showed some number of rheumatoid arthritis markers/Rheumatoid factor quantitative; Drug side effect/side effects from covid vaccine; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Blood work showed some number of rheumatoid arthritis markers/Rheumatoid factor quantitative) 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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe ).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-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) UNK, Citrate free. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Blood work showed some number of rheumatoid arthritis markers/Rheumatoid factor quantitative) (seriousness criterion medically significant), IMMUNISATION REACTION (Drug side effect/side effects from covid vaccine) and INFLAMMATION (Inflammation). At the time of the report, RHEUMATOID ARTHRITIS (Blood work showed some number of rheumatoid arthritis markers/Rheumatoid factor quantitative) and INFLAMMATION (Inflammation) outcome was unknown and IMMUNISATION REACTION (Drug side effect/side effects from covid vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Showed that she had some number RA markers. On an unknown date, Rheumatoid factor quantitative: Rheumatoid factor quantitative. On an unknown date, Scan: Body scan showed inflammation.         No concomitant medications were reported.  No treatment details 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 blood work showed some number of rheumatoid arthritis markers andside effects from covid vaccine with humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of inflamation 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
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Skin disorder
Clinical narrative: Skin was horrible; The patient received vaccine dose 1 on 08-AUG-202 and dose 2 on 18-SEP-2021; Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), SKIN DISORDER (Skin was horrible) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received vaccine dose 1 on 08-AUG-202 and dose 2 on 18-SEP-2021) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced ILLNESS (Sick). On 18-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received vaccine dose 1 on 08-AUG-202 and dose 2 on 18-SEP-2021). On an unknown date, the patient experienced SKIN DISORDER (Skin was horrible). At the time of the report, ILLNESS (Sick), SKIN DISORDER (Skin was horrible) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received vaccine dose 1 on 08-AUG-202 and dose 2 on 18-SEP-2021) outcome 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 the event of skin was horrible and sick was not provided. The reporter assessed event sick was possibly related to Moderna Covid-19 vaccine.  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
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore Arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and PYREXIA (Fever) had resolved.            Concomitant product use was not provided by the reporter.  On an unknown date, the patient had sore arm and fever. No treatment information was provided. The reporter's causality for the event(s) sore arm and fever with humira(adalimumab) 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
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm with first Covid vaccine injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm with first Covid vaccine injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) Citrate free. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm with first Covid vaccine injection). At the time of the report, PAIN IN EXTREMITY (sore arm with first Covid vaccine injection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621705 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Sinusitis, Vitamin D
Clinical narrative: Fever; Tiredness; Weight gain; Vitamin D deficiency; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), VITAMIN D DEFICIENCY (Vitamin D deficiency), SINUSITIS (Sinus infection), FATIGUE (Tiredness) and PYREXIA (Fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    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 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-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) 1 dosage form. In December 2021, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), VITAMIN D DEFICIENCY (Vitamin D deficiency), FATIGUE (Tiredness) and PYREXIA (Fever). At the time of the report, WEIGHT INCREASED (Weight gain), VITAMIN D DEFICIENCY (Vitamin D deficiency) and FATIGUE (Tiredness) outcome was unknown and SINUSITIS (Sinus infection) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100 Degree. On an unknown date, Vitamin D: Lacked.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  On an unknown date BODY TEMPERATURE: 99-100 Degree On an unknown date VITAMIN D: Lacked  Treatment Drugs Not Reported  The reporter's causality for the event(s) of FELT TIRED, WEIGHT GAINED, LACKED VITAMIN D, SINUS INFECTION and FEVER 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   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vitamin D deficiency, Weight increased
Clinical narrative: Fever; Tiredness; Weight gain; Vitamin D deficiency; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), VITAMIN D DEFICIENCY (Vitamin D deficiency), SINUSITIS (Sinus infection), FATIGUE (Tiredness) and PYREXIA (Fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    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 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-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) 1 dosage form. In December 2021, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), VITAMIN D DEFICIENCY (Vitamin D deficiency), FATIGUE (Tiredness) and PYREXIA (Fever). At the time of the report, WEIGHT INCREASED (Weight gain), VITAMIN D DEFICIENCY (Vitamin D deficiency) and FATIGUE (Tiredness) outcome was unknown and SINUSITIS (Sinus infection) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100 Degree. On an unknown date, Vitamin D: Lacked.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  On an unknown date BODY TEMPERATURE: 99-100 Degree On an unknown date VITAMIN D: Lacked  Treatment Drugs Not Reported  The reporter's causality for the event(s) of FELT TIRED, WEIGHT GAINED, LACKED VITAMIN D, SINUS INFECTION and FEVER 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   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Psoriasis
Clinical narrative: Psoriasis flare-up; Off label use in unapproved indication; General body pain/Pain; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up), OFF LABEL USE (Off label use in unapproved indication) and PAIN (General body pain/Pain) 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 and Psoriatic arthritis.    There was no reported medical history.    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 PSORIASIS (Psoriasis flare-up), OFF LABEL USE (Off label use in unapproved indication) and PAIN (General body pain/Pain). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved, OFF LABEL USE (Off label use in unapproved indication) outcome was unknown and PAIN (General body pain/Pain) had resolved.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  No concomitant medications were reported.  It was reported that, the patient had psoriasis, which was coming back, body aches following vaccination and off label use in unapproved indication.  The patient's arthritis was doing well. The patient also had body aches for a few weeks following vaccination.   The patient still had pain and psoriasis, RINVOQ stopped on 01-Feb-2022 and changed to another medicine.  It was unknown if she 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: F
Vaccine: COVID19
Symptoms: Hidradenitis, Influenza like illness, Pain in extremity
Clinical narrative: Hidradenitis suppurativa flare; Flu like symptoms; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (Arm Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received 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) at an unspecified dose. On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (Arm Pain). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (Arm Pain) had resolved.            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.  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the events of  hidradenitis suppurativa flare,  arm pain and flu like symptoms was not provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: PAIN; TIRED/EXHAUSTION; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (PAIN) and FATIGUE (TIRED/EXHAUSTION) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (PAIN) and FATIGUE (TIRED/EXHAUSTION). At the time of the report, PAIN (PAIN) was resolving and FATIGUE (TIRED/EXHAUSTION) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) 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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   No treatment information was provided.  The reporter's causality for the event(s) of Tired/Exhaustion and Pain with Humira (Adalimumab) was no reasonable possibility.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Laboratory test, Pain
Clinical narrative: Inflammation localised/inflammation in hands; Ache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation localised/inflammation in hands), PAIN (Ache) and FATIGUE (Tiredness) in a 48-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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In September 2021, the patient experienced PAIN (Ache) and FATIGUE (Tiredness). On an unknown date, the patient experienced INFLAMMATION (Inflammation localised/inflammation in hands). At the time of the report, INFLAMMATION (Inflammation localised/inflammation in hands) was resolving and PAIN (Ache) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Fine.         No concomitant medications were reported.   On an unknown date, the patient experienced inflammation in hands. In September 2021, the patient experienced felt tired and achy after third covid vaccine booster. Moderna was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antimicrobial susceptibility test, Culture, Dry mouth, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: flu like symptoms; Mouth dryness; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DRY MOUTH (Mouth dryness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-May-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and DRY MOUTH (Mouth dryness). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and DRY MOUTH (Mouth dryness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Investigation: Normal. On 18-Jun-2021, Investigation: Normal. On 18-Jun-2021, SARS-CoV-2 test: (Negative) Negative. On 07-Jul-2021, Antimicrobial susceptibility test: Result not provided. On 07-Jul-2021, Culture: Cephalexin presented. On 07-Jul-2021, Investigation: zinc normal folate high. On 07-Jul-2021, Thyroxine: Normal.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  I was reported that she had patches on tongue and extreme xerostomia with burning sensation in her mouth, mouth was burning, burning pain in her mouth, dry mouth, strange reaction with her mouth. It started off very dry and gradually got worse, dryness. It was acute for at least 8 weeks. Patient also experienced chills, lot od oral issues, she did not feel well due to COVID vaccine. Her tongue and throat were swelling hard and hard to eat, difficulty in swallowing. Sore and tender spot at the base of the neck. Alterations in tongue textures, tongue changed. She has smooth areas in her tongue, and she had a feeling that her throat was closing up and difficulty in swallowing. It was like someone switched the saliva, switch of yeast infection, loose some sleep, patches on tongue.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, SARS-CoV-2 test, Thyroxine
Clinical narrative: flu like symptoms; Mouth dryness; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DRY MOUTH (Mouth dryness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-May-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and DRY MOUTH (Mouth dryness). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and DRY MOUTH (Mouth dryness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Investigation: Normal. On 18-Jun-2021, Investigation: Normal. On 18-Jun-2021, SARS-CoV-2 test: (Negative) Negative. On 07-Jul-2021, Antimicrobial susceptibility test: Result not provided. On 07-Jul-2021, Culture: Cephalexin presented. On 07-Jul-2021, Investigation: zinc normal folate high. On 07-Jul-2021, Thyroxine: Normal.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  I was reported that she had patches on tongue and extreme xerostomia with burning sensation in her mouth, mouth was burning, burning pain in her mouth, dry mouth, strange reaction with her mouth. It started off very dry and gradually got worse, dryness. It was acute for at least 8 weeks. Patient also experienced chills, lot od oral issues, she did not feel well due to COVID vaccine. Her tongue and throat were swelling hard and hard to eat, difficulty in swallowing. Sore and tender spot at the base of the neck. Alterations in tongue textures, tongue changed. She has smooth areas in her tongue, and she had a feeling that her throat was closing up and difficulty in swallowing. It was like someone switched the saliva, switch of yeast infection, loose some sleep, patches on tongue.  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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Rash, Vomiting
Clinical narrative: Vomiting/could not hold food down; Skin breakout; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), RASH (Skin breakout) and VOMITING (Vomiting/could not hold food down) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    There was no reported medical history.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced ILLNESS (Sickness). In December 2021, the patient experienced RASH (Skin breakout). On an unknown date, the patient experienced VOMITING (Vomiting/could not hold food down). At the time of the report, ILLNESS (Sickness), RASH (Skin breakout) and VOMITING (Vomiting/could not hold food down) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.   Skyrizi did not worked for patient.  The patient felt sick after second Covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of illness with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event of rash with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the events of vomiting and drug ineffective was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart issues; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart issues) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 28-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC DISORDER (Heart issues). At the time of the report, CARDIAC DISORDER (Heart issues) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event of heart issues with Humira (adalimumab) was no reasonable possibility. The reporter assessed event heart issues was possibly related to Moderna Covid-19 vaccine.  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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Headache, Vaccination site pain
Clinical narrative: STOMACH WOOZY; ARM HURT AFTER COVID 19 VACCINATION; Headache; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC DISORDER (STOMACH WOOZY), VACCINATION SITE PAIN (ARM HURT AFTER COVID 19 VACCINATION) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-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) (Oral) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (ARM HURT AFTER COVID 19 VACCINATION) and HEADACHE (Headache). On an unknown date, the patient experienced GASTRIC DISORDER (STOMACH WOOZY). At the time of the report, GASTRIC DISORDER (STOMACH WOOZY), VACCINATION SITE PAIN (ARM HURT AFTER COVID 19 VACCINATION) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. On unknown dates, the patient experienced STOMACH WOOZY and ARM WAS HURTING WITH SHINGLE SHOT. In 2021, the patient experienced ARM HURT AFTER COVID 19 VACCINATION and HEADACHE.. In 2021, the patients arm was hurt and had slight headache after taking covid 19 vaccination. She had shingle shot and few side effects like arm was hurting, stomach woozy and also had a headache. 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 STOMACH WOOZY, ARM HURT AFTER COVID 19 VACCINATION, ARM WAS HURTING WITH SHINGLE SHOT and HEADACHE 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: Back disorder, Cough
Clinical narrative: Back trouble due to work she used to do; Cough; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Back trouble due to work she used to do) and COUGH (Cough) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    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) Daily dose: Citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced BACK DISORDER (Back trouble due to work she used to do) and COUGH (Cough). At the time of the report, BACK DISORDER (Back trouble due to work she used to do) had not resolved and COUGH (Cough) had resolved.            Concomitant drugs were not reported.  The patient had received the Booster dose of Moderna COVID-19 vaccine.  The reporter's causality for the events of back trouble due to work she used to do and cough with Humira(Adalimumab) was no reasonable possibility.  Treatment medications were not provided.  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: F
Vaccine: COVID19
Symptoms: Dry skin
Clinical narrative: Dry skin; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry skin) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DRY SKIN (Dry skin). At the time of the report, DRY SKIN (Dry skin) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  No concomitant medications were reported.  The patient reported that, the hands dried out due to sanitizer and was given cream for treatment  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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Initial insomnia, Rash
Clinical narrative: Trouble falling asleep; Dry mouth; headache; Skin breakout; This spontaneous case was reported by a consumer and describes the occurrence of INITIAL INSOMNIA (Trouble falling asleep), DRY MOUTH (Dry mouth), HEADACHE (headache) and RASH (Skin breakout) in a 75-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 Plaque psoriasis.    No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INITIAL INSOMNIA (Trouble falling asleep), DRY MOUTH (Dry mouth), HEADACHE (headache) and RASH (Skin breakout). At the time of the report, INITIAL INSOMNIA (Trouble falling asleep), DRY MOUTH (Dry mouth) and HEADACHE (headache) had not resolved and RASH (Skin breakout) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site urticaria, Pain
Clinical narrative: Injection site pruritus; Pain during injection; Injection site urticaria; Fatigue; ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), INJECTION SITE PRURITUS (Injection site pruritus), FATIGUE (Fatigue), INJECTION SITE PAIN (Pain during injection) and INJECTION SITE URTICARIA (Injection site urticaria) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In March 2021, the patient experienced PAIN (ache) and FATIGUE (Fatigue). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE PAIN (Pain during injection) and INJECTION SITE URTICARIA (Injection site urticaria). At the time of the report, PAIN (ache) and INJECTION SITE PAIN (Pain during injection) outcome was unknown and INJECTION SITE PRURITUS (Injection site pruritus), FATIGUE (Fatigue) and INJECTION SITE URTICARIA (Injection site urticaria) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  On unknown dates, the patient experienced painful injection and itchy welt at injection site. In 2021, the patient experienced fatigue and achiness. In March 2021, the patient experienced fatigue and achiness. In March 2021, the fatigue and achiness resolved. In August 2021, the patient experienced fatigue and achiness.   In 2021, the fatigue and achiness resolved. On an unknown date, ITCHY welt at injection site resolved.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of fatigue onset in March 2021, fatigue onset in 2021, fatigue onset in August 2021, painful injection, itchy welt at injection site unknown onset, itchy welt at injection site unknown onset, achiness onset in March 2021, achiness onset in 2021 and achiness onset in August 2021 with Humira was not provided.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Reporter did not allow further contact