chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on lower parts of body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on lower parts of body) 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.    Concomitant products included IBUPROFEN, TRAMADOL HCL, ALENDRONATE SODIUM, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZID), ATORVASTATIN CALCIUM, IPRATROPIUM BROMIDE, BIMATOPROST (LUMIGAN), SUCRALFATE, TIMOLOL, CODEINE PHOSPHATE, PARACETAMOL (ACETAMINOPHEN AND CODEINE), IPRATROPIUM, AZITHROMYCIN, FLUTICASONE PROPIONATE and METHOTREXATE for an unknown indication.   On 04-Nov-2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced RASH (Rash on lower parts of body). At the time of the report, RASH (Rash on lower parts of body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported by the reporter.  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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Psoriasis
Clinical narrative: PSORIASIS FLARE UP/ DRY SKIN ON SHINS; FELT FATIGUED AND WORN DOWN FROM MODERNA; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS FLARE UP/ DRY SKIN ON SHINS) and FATIGUE (FELT FATIGUED AND WORN DOWN FROM MODERNA) in a 63-year-old male 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.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (FELT FATIGUED AND WORN DOWN FROM MODERNA). On an unknown date, the patient experienced PSORIASIS (PSORIASIS FLARE UP/ DRY SKIN ON SHINS). At the time of the report, PSORIASIS (PSORIASIS FLARE UP/ DRY SKIN ON SHINS) had not resolved and FATIGUE (FELT FATIGUED AND WORN DOWN FROM MODERNA) outcome was unknown.            No concomitant medication was reported. On an unknown date, the patient experienced PSORIASIS FLARE UP/ DRY SKIN ON SHINS. In 2021, the patient experienced FELT FATIGUED AND WORN DOWN FROM MODERNA. Patient had dry skin on shins and felt fatigued and worn down from Moderna vaccines. He agreed to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of PSORIASIS FLARE UP/ DRY SKIN ON SHINS with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event(s) of FELT FATIGUED AND WORN DOWN FROM MODERNA 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Pruritus, Scar
Clinical narrative: Tiredness; Scar; Itching; Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), SCAR (Scar), PRURITUS (Itching) and FATIGUE (Tiredness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 30-May-2021, the patient experienced INFLUENZA (Flu symptoms). On 14-Nov-2021, the patient experienced PRURITUS (Itching). On 09-Dec-2021, the patient experienced SCAR (Scar). On an unknown date, the patient experienced FATIGUE (Tiredness). On 02-Jun-2021, INFLUENZA (Flu symptoms) had resolved. At the time of the report, SCAR (Scar), PRURITUS (Itching) and FATIGUE (Tiredness) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment information was provided.  Patient stated once the 12 weeks between treatments experienced tiredness, itchiness. She stated she as of 09-Dec-2021 had scares but less than normal. She stated after taking the second covid vaccination had flu symptoms.  The reporter's causality for the events of itchiness, tiredness and scares with Skyrizi (risankizumab) was a reasonable possibility and for flu symptoms causality 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: Vaccination site pain
Clinical narrative: COVID BOOSTER CAUSED PATIENT'S ARM TO BE SORE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID BOOSTER CAUSED PATIENT'S ARM TO BE SORE) 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 Ankylosing spondylitis.  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 On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (COVID BOOSTER CAUSED PATIENT'S ARM TO BE SORE). At the time of the report, VACCINATION SITE PAIN (COVID BOOSTER CAUSED PATIENT'S ARM TO BE SORE) had not 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.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK DUE TO MODERNA BOOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICK DUE TO MODERNA BOOOSTER SHOT) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled syringe. In 2021, the patient experienced ILLNESS (SICK DUE TO MODERNA BOOOSTER SHOT). At the time of the report, ILLNESS (SICK DUE TO MODERNA BOOOSTER SHOT) had not resolved.            No concomitant medication was reported. In 2021, the patient experienced SICK DUE TO MODERNA BOOOSTER SHOT. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. No treatment medication was reported.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SICK DUE TO MODERNA BOOOSTER SHOT 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: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Chronic fatigue) in a patient of an unknown age and gender 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 FATIGUE (Chronic fatigue). At the time of the report, FATIGUE (Chronic fatigue) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Peripheral swelling
Clinical narrative: ARM SWOLLEN AND RED; ARM SWOLLEN AND RED; FELT TIRED; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (ARM SWOLLEN AND RED), ERYTHEMA (ARM SWOLLEN AND RED) and FATIGUE (FELT TIRED) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Previously administered products included for Product used for unknown indication: DOXYCYCLINE, AMOXICILLIN and CODEINE. Past adverse reactions to the above products included Allergy with AMOXICILLIN, CODEINE and DOXYCYCLINE. Concurrent medical conditions included Drug allergy (AMOXICILLIN ALLERGY), Drug allergy (DOXYCYCLINE ALLERGY) and Drug allergy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PERIPHERAL SWELLING (ARM SWOLLEN AND RED), ERYTHEMA (ARM SWOLLEN AND RED) and FATIGUE (FELT TIRED). In 2021, FATIGUE (FELT TIRED) had resolved. At the time of the report, PERIPHERAL SWELLING (ARM SWOLLEN AND RED) and ERYTHEMA (ARM SWOLLEN AND RED) outcome was unknown.            No concomitant medication was reported. In 2021, the patient experienced FELT TIRED and ARM SWOLLEN AND RED. In 2021, the FELT TIRED resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of FELT TIRED with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of ARM SWOLLEN AND RED onset in 2021 and ARM SWOLLEN AND RED onset in 2021 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: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; TIRED/a bit tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (TIRED/a bit tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PANCREATIN (CREON) for Ulcerative colitis.    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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and PANCREATIN (CREON) (Oral) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache) and FATIGUE (TIRED/a bit tired). At the time of the report, HEADACHE (Headache) and FATIGUE (TIRED/a bit tired) outcome was unknown.            No concomitant medication was reported. On an unknown date, patient received first, second and booster dose of COVID-19 vaccine manufactured by Moderna. The patient had a mild headache and was a bit tired after the second dose. For the booster dose, patient had mild body aches and was extremely tired for 12 hours and then energy recovered. The onset happened 12 to 16 hours after the shot. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medication was reported.  Primary reporter declined to be contacted.  Causality for CREON(PANCREATIN): The reporter's causality for the event(s) of HEADACHE and TIRED was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624853.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.  No Medical History information was reported.  On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In October 2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). In 2021, SEIZURE (Seizure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (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.  No concomitant medication information was  provided.  It was reported that In Oct 2021, the patient had a seizure, 3 days after covid injection and was not on Rinvoq.  Patient was admitted for one week. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.  Company comment: This spontaneous case concerns a 73-year-old female patient, with no reported medical history, who experienced the unexpected serious (hospitalization and medically significant) AESI of Seizure after receiving a dose of mRNA-1273 vaccine and co-suspect drug Upadacitinib (unknown indication). The event occurred within a year of administration of mRNA-1273 vaccine. It was reported that patient had seizure, 3 days after vaccination and was hospitalized for one week. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. The co-suspect Upadacitinib could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 73-year-old female patient, with no reported medical history, who experienced the unexpected serious (hospitalization and medically significant) AESI of Seizure after receiving a dose of mRNA-1273 vaccine and co-suspect drug Upadacitinib (unknown indication). The event occurred within a year of administration of mRNA-1273 vaccine. It was reported that patient had seizure, 3 days after vaccination and was hospitalized for one week. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. The co-suspect Upadacitinib could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain
Clinical narrative: Inflammation in hand; Pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation in hand) and PAIN (Pain) in a 61-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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Pain). In December 2021, the patient experienced INFLAMMATION (Inflammation in hand). At the time of the report, INFLAMMATION (Inflammation in hand) and PAIN (Pain) outcome was unknown.            No concomitant medication was reported. In 2021, the patient experienced INFLAMMATION IN HAND and PAIN.   In Dec 2021 patient right hand did not close from inflammation, she was in more pain after vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.   Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of INFLAMMATION IN HAND with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of 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: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Headache
Clinical narrative: FLARE UP; Headache; Fatigue; JOINT PAIN WHEN WEATHER CHANGES; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (JOINT PAIN WHEN WEATHER CHANGES) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP), HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (JOINT PAIN WHEN WEATHER CHANGES). At the time of the report, CONDITION AGGRAVATED (FLARE UP) had not resolved and HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (JOINT PAIN WHEN WEATHER CHANGES) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial  No concomitant and treatment information was provided.  The reporter's causality with Humira (adalimumab) for the event condition aggravated was a reasonable possibility, for the events headache and fatigue was no reasonable possibility and for arthralgia 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: Inappropriate schedule of product administration, Musculoskeletal stiffness, Swelling
Clinical narrative: Swelling; STIFFNESS IN BETWEEN; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (STIFFNESS IN BETWEEN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, citrate free. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (STIFFNESS IN BETWEEN). At the time of the report, SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (STIFFNESS IN BETWEEN) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            NO KNOWN ALLERGIES. No concomitant drugs taken. On an unknown date, the patient experienced SWELLING AND STIFFNESS IN BETWEEN. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SWELLING AND STIFFNESS IN BETWEEN unknown onset and SWELLING AND STIFFNESS IN BETWEEN unknown onset with HUMIRA(ADALIMUMAB) 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cortisol, Gastrooesophageal reflux disease, Vaccination site pain
Clinical narrative: DRINKING COFFEE GAVE ACID REFLUX; SORE ARM AFTER COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (DRINKING COFFEE GAVE ACID REFLUX) and VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (DRINKING COFFEE GAVE ACID REFLUX). In 2021, VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (DRINKING COFFEE GAVE ACID REFLUX) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cortisol: elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported. On unknown dates, the patient experienced CORTISONE LEVELS ON BLOODWORK WERE  ELEVATED and DRINKING COFFEE GAVE ACID REFLUX. In 2021, the patient experienced SORE ARM AFTER COVID VACCINE. In 2021, the SORE ARM AFTER COVID VACCINE resolved. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of CORTISONE LEVELS ON BLOODWORK WERE ELEVATED was not provided. The reporter's causality for the event(s) of SORE ARM AFTER COVID VACCINE and DRINKING COFFEE GAVE ACID REFLUX with HUMIRA(ADALIMUMAB) was no reasonable possibility.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous case was reported by a consumer and describes the occurrence of 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.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (FEVER). At the time of the report, PYREXIA (FEVER) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient had no relevant medical history. The patient's other relavant history information reported was no known allergies and no concomitant drugs taken.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 03-Nov-2021, the patient experienced PYREXIA (Fever). On 03-Nov-2021, PYREXIA (Fever) had resolved.            Concomitant Drugs were not reported, as patient had no concomitant drugs taken.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Pyrexia, Skin disorder
Clinical narrative: Itching; Headache; Skin disorder/BUMP UNDER ARMPITS; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), SKIN DISORDER (Skin disorder/BUMP UNDER ARMPITS), PYREXIA (Fever) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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) (Subcutaneous) Citrate Free. On 29-Oct-2021, the patient experienced SKIN DISORDER (Skin disorder/BUMP UNDER ARMPITS) and PYREXIA (Fever). On an unknown date, the patient experienced PRURITUS (Itching) and HEADACHE (Headache). At the time of the report, PRURITUS (Itching) and HEADACHE (Headache) was resolving, SKIN DISORDER (Skin disorder/BUMP UNDER ARMPITS) outcome was unknown and PYREXIA (Fever) had resolved.            The reporter's causality for the event(s) of itchiness, bump under armpits and headache with Humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of fever with Humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Psoriasis, Pyrexia
Clinical narrative: Ache; FEVER; PSORIASIS FLARE UPS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), PYREXIA (FEVER) and PSORIASIS (PSORIASIS FLARE UPS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.  No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Ache), PYREXIA (FEVER) and PSORIASIS (PSORIASIS FLARE UPS). At the time of the report, PAIN (Ache), PYREXIA (FEVER) and PSORIASIS (PSORIASIS FLARE UPS) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (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.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Rhinorrhoea, Throat irritation
Clinical narrative: Runny nose; Scratchy throat; Loss of voice; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), THROAT IRRITATION (Scratchy throat) and APHONIA (Loss of voice) 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 Rheumatoid arthritis.    No Medical History information was reported.   On 07-Sep-2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 03-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 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced RHINORRHOEA (Runny nose), THROAT IRRITATION (Scratchy throat) and APHONIA (Loss of voice). In 2021, RHINORRHOEA (Runny nose), THROAT IRRITATION (Scratchy throat) and APHONIA (Loss of voice) 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.
Sex: F
Vaccine: COVID19
Symptoms: Hysterectomy, Neoplasm, Pain
Clinical narrative: Tumor; Hysterectomy; Pain; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM (Tumor) and HYSTERECTOMY (Hysterectomy) 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 Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NEOPLASM (Tumor) (seriousness criterion medically significant), HYSTERECTOMY (Hysterectomy) (seriousness criterion medically significant) and PAIN (Pain). At the time of the report, NEOPLASM (Tumor) had not resolved and HYSTERECTOMY (Hysterectomy) and PAIN (Pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant Medication use information was not provided by reporter.  On unknown dates, the patient experienced tumor and sore from covid vaccine. On an unknown date patient had Hysterectomy.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality of humira for the event(s) of tumor was no reasonable possibility and for sore from covid vaccine was not provided.  Treatment Medication use information was not provided 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.  Company comment.  This spontaneous case concerns an adult female patient, with no relevant medical history, who received a dose of mRNA-1273 and experienced the non  serious unexpected medically significant events of neoplasm and hysterectomy. Vaccination date and onset date of the events were not reported; hence latency and temporal association cannot be properly assessed. No further clinical information regarding have been provided for medical reviewing. Co-suspect product included Adalimumab. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient, with no relevant medical history, who received a dose of mRNA-1273 and experienced the non  serious unexpected medically significant events of neoplasm and hysterectomy. Vaccination date and onset date of the events were not reported; hence latency and temporal association cannot be properly assessed. No further clinical information regarding have been provided for medical reviewing. Co-suspect product included Adalimumab. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Scarlet fever, Skin plaque
Clinical narrative: Scarlet fever; Hands were covered with plaques and had not improved much; This spontaneous case was reported by a consumer and describes the occurrence of SCARLET FEVER (Scarlet fever) and SKIN PLAQUE (Hands were covered with plaques and had not improved much) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    No Medical History information was reported.   In 2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCARLET FEVER (Scarlet fever) and SKIN PLAQUE (Hands were covered with plaques and had not improved much). In 2021, SCARLET FEVER (Scarlet fever) had resolved. At the time of the report, SKIN PLAQUE (Hands were covered with plaques and had not improved much) had not resolved.            No concomitant medication information was reported.  On unknown dates, the patient experienced hands were covered with plaques and had not improved much on skyrizi and scarlet fever. On 06 Apr 2021,the patient had scarlet fever.  No treatment medication was reported.  In 2021, the scarlet fever was resolved. On an unknown date, Scarlet fever was resolved.  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.   This case was linked to MOD-2021-117685 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Fatigue, Pyrexia
Clinical narrative: Dizzy; Fatigue extreme/extremely tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FATIGUE (Fatigue extreme/extremely tired) and PYREXIA (Fever) 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 Ankylosing spondylitis.    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 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced DIZZINESS (Dizzy), FATIGUE (Fatigue extreme/extremely tired) and PYREXIA (Fever). At the time of the report, DIZZINESS (Dizzy), FATIGUE (Fatigue extreme/extremely tired) and PYREXIA (Fever) had resolved.            Concomitant product use was not provided by the reporter. 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   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Non-Significant live Follow Up Appended and no new information added.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Spinal operation
Clinical narrative: back surgery; BODY FELT ACHY; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (back surgery) in a 52-year-old male 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 Hidradenitis.    Concurrent medical conditions included Hidradenitis suppurativa.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced MYALGIA (BODY FELT ACHY). On an unknown date, the patient experienced SPINAL OPERATION (back surgery) (seriousness criterion medically significant). In February 2021, MYALGIA (BODY FELT ACHY) had resolved. At the time of the report, SPINAL OPERATION (back surgery) was resolving.            No concomitant medications were reported. No treatment medications information were provided. On an unknown date, patient had back surgery, a spinal operation NOS.   Somewhere in JAN2021, the patient felt like flu and event resolved.   Reporters causality for event 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.  Company comment: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of spinal operation 11 months after the second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623688 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow up contains significant information.  Seriousness criteria , event Information and narrative  updated.; Sender's Comments: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of spinal operation 11 months after the second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICKNESS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    It was unknown if the patient was enrolled in covid-19 vaccine trial.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced ILLNESS (SICKNESS). At the time of the report, ILLNESS (SICKNESS) 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.  The concomitant medication was not reported.  The reporter causality for the events with respect to Rinviq was provided as no reasonable possibility.  The treatment medication was not provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Bronchitis, Chest pain, Dysphonia
Clinical narrative: Knee effusion; Hoarse voice; Feeling hot; Anxiety; Bronchitis; Chest pain; Breathing difficult; Weakness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT EFFUSION (Knee effusion), DYSPHONIA (Hoarse voice), FEELING HOT (Feeling hot), ANXIETY (Anxiety) and BRONCHITIS (Bronchitis) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    It was unknown if the patient was enrolled in an clinical trials.  Concurrent medical conditions included Rheumatoid arthritis.   In August 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced JOINT EFFUSION (Knee effusion), DYSPHONIA (Hoarse voice), FEELING HOT (Feeling hot), ANXIETY (Anxiety), BRONCHITIS (Bronchitis), CHEST PAIN (Chest pain), DYSPNOEA (Breathing difficult), ASTHENIA (Weakness) and PYREXIA (Fever). The patient was treated with ALPRAZOLAM (XANAX) at a dose of 1 dosage form. At the time of the report, JOINT EFFUSION (Knee effusion) had not resolved and DYSPHONIA (Hoarse voice), FEELING HOT (Feeling hot), ANXIETY (Anxiety), BRONCHITIS (Bronchitis), CHEST PAIN (Chest pain), DYSPNOEA (Breathing difficult), ASTHENIA (Weakness) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (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.  The concomitant medication was not reported.  The causality for the events Knee effusion with respect to Humira was reported as reasonable possibility. The causality for the events Weakness,Feeling hot, Fever, Chest pain,Breathing difficult with respect to Humira was reported as No reasonable possibility.  The causality for the events Anxiety, Bronchitis with respect to Humira was reported as not reported.