chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 39-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 Crohn's disease.    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 ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            No concomitant medication information was provided. 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, UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm for all three covid-19 vaccine; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for all three covid-19 vaccine) and PAIN (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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for all three covid-19 vaccine) and PAIN (Pain). At the time of the report, PAIN IN EXTREMITY (Sore arm for all three covid-19 vaccine) had resolved and PAIN (Pain) outcome was unknown. Not Provided          The patient reported that RINVOQ was not working and needed to use another medication for the full effect of her feeling well. She found out that she was not supposed to take out RINVOQ pills to stored them in her weekly pill box so they were not as effective. If she would have kept them in stored bottle. She immediately changed that.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hip fracture
Clinical narrative: BROKE HIP; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (BROKE HIP) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In February 2021, the patient experienced HIP FRACTURE (BROKE HIP) (seriousness criterion medically significant). In 2021, the patient experienced FATIGUE (TIRED). In 2021, HIP FRACTURE (BROKE HIP) had resolved. At the time of the report, FATIGUE (TIRED) had not resolved.            Concomitant Drugs Not Reported. 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.  Company comment-This spontaneous case concerns an elderly female patient aged 69 years with relevant medical history of RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (medically significant) event of Hip fracture that occurred on an unknown date (in Feb.2021) after first dose of mRNA-1273 vaccination. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. Patients elderly age and relevant medical history could be  risk factors to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns an elderly female patient aged 69 years with relevant medical history of RHEUMATOID ARTHRITIS reported, who experienced the unexpected serious (medically significant) event of Hip fracture that occurred on an unknown date (in Feb.2021) after first dose of mRNA-1273 vaccination. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. Patients elderly age and relevant medical history could be  risk factors to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Upset stomach/Upset stomach after covid vaccine booster dose; Feeling abnormal/Felt a bit off since covid vaccine booster dose; Fatigue/Fatigue after covid vaccine booster dose; Pain in arm/Arm soreness after covid vaccine booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach/Upset stomach after covid vaccine booster dose), FEELING ABNORMAL (Feeling abnormal/Felt a bit off since covid vaccine booster dose), FATIGUE (Fatigue/Fatigue after covid vaccine booster dose) and PAIN IN EXTREMITY (Pain in arm/Arm soreness after covid vaccine booster dose) 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 Psoriatic 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) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach/Upset stomach after covid vaccine booster dose), FEELING ABNORMAL (Feeling abnormal/Felt a bit off since covid vaccine booster dose), FATIGUE (Fatigue/Fatigue after covid vaccine booster dose) and PAIN IN EXTREMITY (Pain in arm/Arm soreness after covid vaccine booster dose). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach/Upset stomach after covid vaccine booster dose), FEELING ABNORMAL (Feeling abnormal/Felt a bit off since covid vaccine booster dose), FATIGUE (Fatigue/Fatigue after covid vaccine booster dose) and PAIN IN EXTREMITY (Pain in arm/Arm soreness after covid vaccine booster dose) outcome was unknown.            No concomitant medications were reported. No treatment drugs 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pneumonia, Stomatitis
Clinical narrative: Sores mouth; Fever blister; Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and ORAL HERPES (Fever blister). On an unknown date, the patient experienced STOMATITIS (Sores mouth). At the time of the report, PNEUMONIA (Pneumonia), STOMATITIS (Sores mouth) and ORAL HERPES (Fever blister) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  The reporters causality for events with HUMIRA was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment: This spontaneous case concerns a 69 year old female patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Pneumonia, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received the second dose from the same vaccine on an unknown date. No information on exact date of the events and vaccination schedule, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concomitant adalimumab could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69 year old female patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Pneumonia, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received the second dose from the same vaccine on an unknown date. No information on exact date of the events and vaccination schedule, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concomitant adalimumab could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Chills, Hepatic steatosis, Pain
Clinical narrative: Third COVID shot got chills and sore and fatty liver; Third COVID shot got chills and sore and fatty liver; Third COVID shot got chills and sore and fatty liver; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC STEATOSIS (Third COVID shot got chills and sore and fatty liver), PAIN (Third COVID shot got chills and sore and fatty liver) and CHILLS (Third COVID shot got chills and sore and fatty liver) 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.    Previously administered products included for Product used for unknown indication: ALTACE, PRAVACHOL, FOSAMAX and CIPRO. Past adverse reactions to the above products included Drug allergy with CIPRO; and No adverse event with ALTACE, FOSAMAX and PRAVACHOL. Concurrent medical conditions included Drug allergy, Drug allergy, Allergy, Protein allergy, Drug allergy and Drug allergy.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced HEPATIC STEATOSIS (Third COVID shot got chills and sore and fatty liver), PAIN (Third COVID shot got chills and sore and fatty liver) and CHILLS (Third COVID shot got chills and sore and fatty liver). At the time of the report, HEPATIC STEATOSIS (Third COVID shot got chills and sore and fatty liver) was resolving and PAIN (Third COVID shot got chills and sore and fatty liver) and CHILLS (Third COVID shot got chills and sore and fatty liver) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Fatty liver.         IT was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient past medication was penicillin for unknown indication.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Device issue, Fatigue, Vaccination site pain
Clinical narrative: Device issue; Vaccination site pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE ISSUE (Device issue), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) in a 22-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 Crohn's disease.    No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-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 syringe. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue). On an unknown date, the patient experienced DEVICE ISSUE (Device issue). In 2021, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) had resolved. At the time of the report, DEVICE ISSUE (Device issue) had resolved.            No concomitant medication information was provided. 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.   This case was linked to MOD-2021-622914.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Left wrist pain which drastically affected.; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Left wrist pain which drastically affected.) and PYREXIA (Fever) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (Fever). In September 2021, the patient experienced ARTHRALGIA (Left wrist pain which drastically affected.). In 2021, PYREXIA (Fever) had resolved. At the time of the report, ARTHRALGIA (Left wrist pain which drastically affected.) had not resolved.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of LEFT WRIST PAIN WHICH DRASTICALLY AFFECTED was not provided. 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.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching; hives and welps from head to toe; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (Itching) and URTICARIA (hives and welps from head to toe) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 07-Aug-2021, the patient experienced PRURITUS (Itching) and URTICARIA (hives and welps from head to toe). At the time of the report, PRURITUS (Itching) and URTICARIA (hives and welps from head to toe) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; On 05 Mar 2021, she received first dose of COVID-19 vaccine manufactured by Moderna. On 21 Apr 2021, she received second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 05 Mar 2021, she received first dose of COVID-19 vaccine manufactured by Moderna. On 21 Apr 2021, she received second dose) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-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) Citrate Free. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 05 Mar 2021, she received first dose of COVID-19 vaccine manufactured by Moderna. On 21 Apr 2021, she received second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 05 Mar 2021, she received first dose of COVID-19 vaccine manufactured by Moderna. On 21 Apr 2021, she received second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications was reported. No treatment medications 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.   This case was linked to MOD-2021-622911.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness, Nausea
Clinical narrative: Stiffness in shoulders that moves from one shoulder to other.; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in shoulders that moves from one shoulder to other.) and NAUSEA (Nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 MUSCULOSKELETAL STIFFNESS (Stiffness in shoulders that moves from one shoulder to other.) and NAUSEA (Nausea). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in shoulders that moves from one shoulder to other.) and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of STIFFNESS IN SHOULDERS THAT MOVES FROM ONE SHOULDER TO OTHER with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of NAUSEA 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: Myocardial infarction
Clinical narrative: He had 2 heart attacks; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (He had 2 heart attacks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  The patient's past medical history included Coronary artery disease. 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 MYOCARDIAL INFARCTION (He had 2 heart attacks) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (He had 2 heart attacks) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant products were reported. No treatment information was reported by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a male patient, with relevant medical history of coronary artery disease, who received a dose of mRNA-1273 vaccine and experienced the serious medically significant unexpected AESI of myocardial infarction. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further clinical information regarding have been provided for medical review. Patient´s mentioned medical history remains as risk factor for the event. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, with relevant medical history of coronary artery disease, who received a dose of mRNA-1273 vaccine and experienced the serious medically significant unexpected AESI of myocardial infarction. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further clinical information regarding have been provided for medical review. Patient´s mentioned medical history remains as risk factor for the event. The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Light headedness and dizzy spells; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness and dizzy spells) and PAIN IN EXTREMITY (Arm soreness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Light headedness and dizzy spells) and PAIN IN EXTREMITY (Arm soreness). At the time of the report, DIZZINESS (Light headedness and dizzy spells) and PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event(s) of LIGHT HEADEDNESS AND DIZZY SPELLS and ARM SORENESS with RINVOQ was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Chills, Pain
Clinical narrative: Generalized aching/Heavy body aches due to covid vaccination; Chills/Cold shakes due to covid vaccination; COVID-19/Contracted covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/Contracted covid-19), PAIN (Generalized aching/Heavy body aches due to covid vaccination) and CHILLS (Chills/Cold shakes due to covid vaccination) in a 50-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2020, the patient experienced COVID-19 (COVID-19/Contracted covid-19). On an unknown date, the patient experienced PAIN (Generalized aching/Heavy body aches due to covid vaccination) and CHILLS (Chills/Cold shakes due to covid vaccination). At the time of the report, COVID-19 (COVID-19/Contracted covid-19) and PAIN (Generalized aching/Heavy body aches due to covid vaccination) had resolved and CHILLS (Chills/Cold shakes due to covid vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On unknown dates, the patient experienced cold shakes due to covid vaccination and heavy body aches due to covid vaccination. In November 2020, the patient experienced contracted covid-19. On unknown dates, heavy body aches due to covid vaccination and contracted covid-19 resolved. Moderna vaccine was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Vaccination site rash
Clinical narrative: Vaccination site rash/red raised itchy tender rash; Cramps of upper extremities/muscle spasms in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash/red raised itchy tender rash) and MUSCLE SPASMS (Cramps of upper extremities/muscle spasms in the arm) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Hidradenitis suppurativa symptoms).   On 19-Jun-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram. On 03-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 17-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash/red raised itchy tender rash) and MUSCLE SPASMS (Cramps of upper extremities/muscle spasms in the arm). At the time of the report, VACCINATION SITE RASH (Vaccination site rash/red raised itchy tender rash) had not resolved and MUSCLE SPASMS (Cramps of upper extremities/muscle spasms in the arm) outcome was unknown. Not Provided      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. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fall, Headache, Insomnia, Musculoskeletal discomfort
Clinical narrative: stomach bothers her; can't straighten up her back; weight loss; walker user; hard time sleeping; fell; sever pain in leg; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach bothers her), MUSCULOSKELETAL DISCOMFORT (can't straighten up her back), WEIGHT DECREASED (weight loss), WALKING AID USER (walker user) and INSOMNIA (hard time sleeping) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ABDOMINAL DISCOMFORT (stomach bothers her), MUSCULOSKELETAL DISCOMFORT (can't straighten up her back), WEIGHT DECREASED (weight loss), WALKING AID USER (walker user), INSOMNIA (hard time sleeping), FALL (fell), PAIN IN EXTREMITY (sever pain in leg) and HEADACHE (headaches). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) in 2021 at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (stomach bothers her), MUSCULOSKELETAL DISCOMFORT (can't straighten up her back), WEIGHT DECREASED (weight loss), WALKING AID USER (walker user), PAIN IN EXTREMITY (sever pain in leg) and HEADACHE (headaches) had not resolved and INSOMNIA (hard time sleeping) and FALL (fell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported Patient received an unspecified pill for leg pain. This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Walking aid user, Weight decreased
Clinical narrative: stomach bothers her; can't straighten up her back; weight loss; walker user; hard time sleeping; fell; sever pain in leg; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach bothers her), MUSCULOSKELETAL DISCOMFORT (can't straighten up her back), WEIGHT DECREASED (weight loss), WALKING AID USER (walker user) and INSOMNIA (hard time sleeping) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ABDOMINAL DISCOMFORT (stomach bothers her), MUSCULOSKELETAL DISCOMFORT (can't straighten up her back), WEIGHT DECREASED (weight loss), WALKING AID USER (walker user), INSOMNIA (hard time sleeping), FALL (fell), PAIN IN EXTREMITY (sever pain in leg) and HEADACHE (headaches). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) in 2021 at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (stomach bothers her), MUSCULOSKELETAL DISCOMFORT (can't straighten up her back), WEIGHT DECREASED (weight loss), WALKING AID USER (walker user), PAIN IN EXTREMITY (sever pain in leg) and HEADACHE (headaches) had not resolved and INSOMNIA (hard time sleeping) and FALL (fell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported Patient received an unspecified pill for leg pain. This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasal congestion, Pain, Vaccination site pain
Clinical narrative: Cough; stuffy nose; body aches; Sore arm; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough), NASAL CONGESTION (stuffy nose), PAIN (body aches), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 096b21a and 032b21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced COUGH (Cough), NASAL CONGESTION (stuffy nose), PAIN (body aches), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue). At the time of the report, COUGH (Cough), NASAL CONGESTION (stuffy nose), PAIN (body aches), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue) had not resolved.            No concomitant medication was reported No treatment medication was reported. Patient had not tested positive for COVID-19 since the vaccination. Patient had not received any other vaccine within 4 weeks prior to COVID-19 vaccine.  This case was identified as a part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation.
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy in thumb and some toes; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in thumb and some toes) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in thumb and some toes) (seriousness criterion medically significant). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in thumb and some toes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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 elderly male patient of unknown age with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of neuropathy peripheral an unknown time after a dose of mRNA-1273. The patient was treated with acetaminophen. Information regarding clinical evaluation and diagnostic tests has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly male patient of unknown age with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of neuropathy peripheral an unknown time after a dose of mRNA-1273. The patient was treated with acetaminophen. Information regarding clinical evaluation and diagnostic tests has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fibromyalgia, Vaccination site pain
Clinical narrative: Fibromyalgia; Both COVID vaccines caused pain; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia) and VACCINATION SITE PAIN (Both COVID vaccines caused pain) in a 58-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.    Concurrent medical conditions included Rheumatoid arthritis.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced VACCINATION SITE PAIN (Both COVID vaccines caused pain). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia). In 2021, VACCINATION SITE PAIN (Both COVID vaccines caused pain) had resolved. At the time of the report, FIBROMYALGIA (Fibromyalgia) outcome was unknown.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 58-year-old female patient, with concurrent medical condition of rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of fibromyalgia. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious event of vaccination site pain. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Female gender and concurrent medical condition of rheumatoid arthritis represent risk factors for developing fibromyalgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-623066 (Patient Link).; Sender's Comments: This is a spontaneous case reported by a consumer. A 58-year-old female patient, with concurrent medical condition of rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of fibromyalgia. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious event of vaccination site pain. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Female gender and concurrent medical condition of rheumatoid arthritis represent risk factors for developing fibromyalgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Psoriatic arthritis, Ankylosing spondylitis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis, Ankylosing spondylitis and Plaque psoriasis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, 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., ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported.   The reporter's causality for the event of headache with humira was not provided. The reporter's causality for the events of fever and chills with humira(adalimumab) was no reasonable possibility.  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   No treatment information was provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, Arthralgia, Chills, Muscle fatigue, Musculoskeletal stiffness
Clinical narrative: Muscle fatigue; Stiffness; Chills; Fever; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), CHILLS (Chills), PYREXIA (Fever) and ARTHRALGIA (Aching joints) 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 Crohn's disease and 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) at an unspecified dose. On an unknown date, the patient experienced MUSCLE FATIGUE (Muscle fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), CHILLS (Chills), PYREXIA (Fever) and ARTHRALGIA (Aching joints). At the time of the report, MUSCLE FATIGUE (Muscle fatigue), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Stiffness) and ARTHRALGIA (Aching joints) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication were provided The reporter's causality for the event(s) of Lab work showed too many antibodies following Covid  vaccination 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
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: Muscle fatigue; Stiffness; Chills; Fever; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), CHILLS (Chills), PYREXIA (Fever) and ARTHRALGIA (Aching joints) 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 Crohn's disease and 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) at an unspecified dose. On an unknown date, the patient experienced MUSCLE FATIGUE (Muscle fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), CHILLS (Chills), PYREXIA (Fever) and ARTHRALGIA (Aching joints). At the time of the report, MUSCLE FATIGUE (Muscle fatigue), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Stiffness) and ARTHRALGIA (Aching joints) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication were provided The reporter's causality for the event(s) of Lab work showed too many antibodies following Covid  vaccination 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