chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vitamin D deficiency
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VITAMIN D DEFICIENCY (NEEDS MORE VITAMIN D) and VACCINATION SITE PAIN (SORE ARM AFTER VACCINATION) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-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 VITAMIN D DEFICIENCY (NEEDS MORE VITAMIN D) and VACCINATION SITE PAIN (SORE ARM AFTER VACCINATION). At the time of the report, VITAMIN D DEFICIENCY (NEEDS MORE VITAMIN D) and VACCINATION SITE PAIN (SORE ARM AFTER VACCINATION) had resolved. No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the events of NEEDS MORE VITAMIN D and SORE ARM AFTER VACCINATION was not provided. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (AFib) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient of an unknown age and gender  with no reported medical history, who experienced the serious (medically significant) unexpected AESI Atrial fibrillation, on an unknown date after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report. 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.; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender  with no reported medical history, who experienced the serious (medically significant) unexpected AESI Atrial fibrillation, on an unknown date after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: COVID VACCINE SIDE EFFECT/HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (COVID VACCINE SIDE EFFECT/HEADACHE) 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) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   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 HEADACHE (COVID VACCINE SIDE EFFECT/HEADACHE). At the time of the report, HEADACHE (COVID VACCINE SIDE EFFECT/HEADACHE) 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.  The suspect drug daily dose was reported as citrate free.  No treatment medication information was provided.
Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Urticaria
Clinical narrative: PSORIASIS BREAKOUT; HIVES OUTBREAK/BROKE OUT IN HIVES ON ARMS/CHEST AND BACK; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS BREAKOUT) and URTICARIA (HIVES OUTBREAK/BROKE OUT IN HIVES ON ARMS/CHEST AND BACK) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    The patient's past medical history included Hives, Sepsis, Unevaluable reaction and Heart valve operation. Concurrent medical conditions included Drug allergy, Plaque psoriasis and Psoriatic arthritis.   On 02-Sep-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) Citrate free. On an unknown date, the patient experienced PSORIASIS (PSORIASIS BREAKOUT) and URTICARIA (HIVES OUTBREAK/BROKE OUT IN HIVES ON ARMS/CHEST AND BACK). At the time of the report, PSORIASIS (PSORIASIS BREAKOUT) and URTICARIA (HIVES OUTBREAK/BROKE OUT IN HIVES ON ARMS/CHEST AND BACK) had not resolved.            Concomitant medication was not reported.  The patient was on previous medication that led to similar psoriasis or hives breakout that led to sepsis and it leading to heart valve surgeries.   It was not sure if psoriasis or hives breakout could be due to the second vaccine however, he previously took other medication with similar adverse event that led to other severe complications. HUMIRA seemed to be working on his psoriasis arthritis and got better then recurred with worse flare up on feet. Treatment details not reported.  Primary reporter wondered if adverse event could be due to the vaccine, although another medication caused similar adverse event.  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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Live follow-up added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: TREMOR/SHAKING IN BOTH HANDS; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (TREMOR/SHAKING IN BOTH HANDS) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Oct-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 TREMOR (TREMOR/SHAKING IN BOTH HANDS). At the time of the report, TREMOR (TREMOR/SHAKING IN BOTH HANDS) had not resolved.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of TREMOR/SHAKING IN BOTH HANDS with RINVOQ(UPADACITINIB) was a reasonable possibility No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Moderna booster shot and I had a COVID test that came back positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Moderna booster shot and I had a COVID test that came back positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (2nd dose) and Pfizer vaccine (1st dose). Past adverse reactions to the above products included No adverse reaction with Pfizer vaccine and Pfizer vaccine.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced COVID-19 (Moderna booster shot and I had a COVID test that came back positive). At the time of the report, COVID-19 (Moderna booster shot and I had a COVID test that came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2021, SARS-CoV-2 test: (Positive) positive.         No medical history information was reported. 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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (LOW WBC COUNT/White blood cell count low) in a 44-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 and Ankylosing spondylitis. Concurrent medical conditions included Ankylosing spondylitis and Crohn's disease. 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 14-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 01-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 WHITE BLOOD CELL COUNT DECREASED (LOW WBC COUNT/White blood cell count low). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (LOW WBC COUNT/White blood cell count low) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, White blood cell count: 3.1 No unit. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication were reported. The reporters causality for the event(s) of LOW WBC COUNT with HUMIRA(ADALIMUMAB) was a reasonable possibility. No treatment medication were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Headache, Nausea
Clinical narrative: SICK TO STOMACH; STOMACH ACHE; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (SICK TO STOMACH), ABDOMINAL PAIN UPPER (STOMACH ACHE), HEADACHE (Headache) and NAUSEA (Nausea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced ABDOMINAL DISCOMFORT (SICK TO STOMACH), ABDOMINAL PAIN UPPER (STOMACH ACHE), HEADACHE (Headache) and NAUSEA (Nausea). In 2021, ABDOMINAL PAIN UPPER (STOMACH ACHE), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (SICK TO STOMACH) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of SICK TO STOMACH was not provided. The reporters causality for the events of HEADACHE and STOMACH ACHE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: UNWELL; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (UNWELL) and FATIGUE (TIRED) in a 49-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 an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 08-Sep-2021, the patient experienced MALAISE (UNWELL) and FATIGUE (TIRED). At the time of the report, MALAISE (UNWELL) and FATIGUE (TIRED) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of TIRED and UNWELL was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Ageusia, Anosmia, Injection site bruising, Injection site haemorrhage, Injection site swelling
Clinical narrative: Joint lock; Injection site bruising; Injection site bleeding; Injection site swelling; Loss of smell; Loss of taste; Joint range of motion decreased; Neck pain; Cold; This spontaneous case was reported by a consumer and describes the occurrence of JOINT LOCK (Joint lock), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), NECK PAIN (Neck pain), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) in a 62-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 Ulcerative colitis.    No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In April 2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) and NECK PAIN (Neck pain). In 2021, the patient experienced NASOPHARYNGITIS (Cold). On 14-Sep-2021, the patient experienced INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE HAEMORRHAGE (Injection site bleeding) and INJECTION SITE SWELLING (Injection site swelling). In September 2021, the patient experienced ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). On an unknown date, the patient experienced JOINT LOCK (Joint lock). At the time of the report, JOINT LOCK (Joint lock), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) and NECK PAIN (Neck pain) had not resolved, ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown and INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE HAEMORRHAGE (Injection site bleeding), NASOPHARYNGITIS (Cold) and INJECTION SITE SWELLING (Injection site swelling) was resolving.            No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed all the events as possibly related to Moderna vaccine.  The reporter assessed the events of injection site bruising and injection site bleeding as reasonably possible to Humira and did not provide any causality assessment for the rest of the events with Humira.  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: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Joint lock, Joint range of motion decreased, Nasopharyngitis, Neck pain
Clinical narrative: Joint lock; Injection site bruising; Injection site bleeding; Injection site swelling; Loss of smell; Loss of taste; Joint range of motion decreased; Neck pain; Cold; This spontaneous case was reported by a consumer and describes the occurrence of JOINT LOCK (Joint lock), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), NECK PAIN (Neck pain), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) in a 62-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 Ulcerative colitis.    No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In April 2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) and NECK PAIN (Neck pain). In 2021, the patient experienced NASOPHARYNGITIS (Cold). On 14-Sep-2021, the patient experienced INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE HAEMORRHAGE (Injection site bleeding) and INJECTION SITE SWELLING (Injection site swelling). In September 2021, the patient experienced ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). On an unknown date, the patient experienced JOINT LOCK (Joint lock). At the time of the report, JOINT LOCK (Joint lock), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) and NECK PAIN (Neck pain) had not resolved, ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown and INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE HAEMORRHAGE (Injection site bleeding), NASOPHARYNGITIS (Cold) and INJECTION SITE SWELLING (Injection site swelling) was resolving.            No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed all the events as possibly related to Moderna vaccine.  The reporter assessed the events of injection site bruising and injection site bleeding as reasonably possible to Humira and did not provide any causality assessment for the rest of the events with Humira.  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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scratch, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: THAT EVENING SHE GOT ITCHY AND SCRATCHY; THAT EVENING SHE GOT ITCHY AND SCRATCHY; HER ARM WAS RED AND INFLAMED; HER ARM WAS RED AND INFLAMED; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (THAT EVENING SHE GOT ITCHY AND SCRATCHY), PRURITUS (THAT EVENING SHE GOT ITCHY AND SCRATCHY), VACCINATION SITE ERYTHEMA (HER ARM WAS RED AND INFLAMED) and VACCINATION SITE INFLAMMATION (HER ARM WAS RED AND INFLAMED) in a 74-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 Uveitis.    Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 2, ROA : Intramuscular.), COVID-19 Vaccine (Dose 1 and ROA : Intramuscular.). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced SCRATCH (THAT EVENING SHE GOT ITCHY AND SCRATCHY), PRURITUS (THAT EVENING SHE GOT ITCHY AND SCRATCHY), VACCINATION SITE ERYTHEMA (HER ARM WAS RED AND INFLAMED) and VACCINATION SITE INFLAMMATION (HER ARM WAS RED AND INFLAMED). At the time of the report, SCRATCH (THAT EVENING SHE GOT ITCHY AND SCRATCHY) outcome was unknown and PRURITUS (THAT EVENING SHE GOT ITCHY AND SCRATCHY), VACCINATION SITE ERYTHEMA (HER ARM WAS RED AND INFLAMED) and VACCINATION SITE INFLAMMATION (HER ARM WAS RED AND INFLAMED) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of PATIENT RECEIVED BOOSTER VACCINE/THAT EVENING SHE GOT ITCHY AND SCRATCHY, PATIENT RECEIVED BOOSTER VACCINE/HER ARM WAS RED AND INFLAMED onset in 2021 and PATIENT RECEIVED BOOSTER VACCINE/HER ARM WAS RED AND INFLAMED onset in 2021 was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: COLD LIKE SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (COLD LIKE SYMPTOMS) in a 26-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 an unknown indication. No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-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 NASOPHARYNGITIS (COLD LIKE SYMPTOMS). At the time of the report, NASOPHARYNGITIS (COLD LIKE SYMPTOMS) had not resolved. It was unknown if patient was enrolled in a COVID-19 vaccine Trial. No concomitant medication were reported. The reporters causality for the events of COLD LIKE SYMPTOMS with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment medication were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Nausea
Clinical narrative: Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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) Citerate free, Solution for injection in pre-filled pen. On 04-Apr-2021, the patient experienced CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills) and NAUSEA (Nausea) was resolving.            The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PAIN (Pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced COVID-19 (COVID-19) and PAIN (Pain). At the time of the report, COVID-19 (COVID-19) and PAIN (Pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Event outcome updated. New event added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue/tired with second shot of covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/tired with second shot of covid vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue/tired with second shot of covid vaccine). At the time of the report, FATIGUE (Fatigue/tired with second shot of covid vaccine) had not resolved.            No relevant concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19 vaccine trial.  The reporter causality for the event fatigue/tired with second shot of covid vaccine with humira was reported as not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Rhinorrhoea, Vaccination site pain
Clinical narrative: Severe flu-like symptoms; Kept having a lot of mucus/lot of mucus from their nostrils; Her husband and her both got sick; Arm was sore; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Severe flu-like symptoms), RHINORRHOEA (Kept having a lot of mucus/lot of mucus from their nostrils), ILLNESS (Her husband and her both got sick) and VACCINATION SITE PAIN (Arm was sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Severe flu-like symptoms), RHINORRHOEA (Kept having a lot of mucus/lot of mucus from their nostrils), ILLNESS (Her husband and her both got sick) and VACCINATION SITE PAIN (Arm was sore). At the time of the report, INFLUENZA LIKE ILLNESS (Severe flu-like symptoms), RHINORRHOEA (Kept having a lot of mucus/lot of mucus from their nostrils), ILLNESS (Her husband and her both got sick) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter reported about the Pfizer COVID-19 vaccine booster shot which she said she had received. She said her arm was sore the first day but a few days after that she had severe flu-like symptoms and kept having a lot of mucus. Reporter said her husband and her both got sick, her husband had received Moderna. She said they both were getting a lot of mucus from their nostrils and can't figure out what was going on. Reporter said she doesn't know if that was one of the side effects or if the booster dose was more stronger. Reporter said her husband's symptoms were the same as hers.  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: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia
Clinical narrative: muscle pain in legs; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain in legs) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-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 July 2021, the patient experienced MYALGIA (muscle pain in legs). In July 2021, MYALGIA (muscle pain in legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Action taken with co-suspect UPADACITINIB (RINVOQ) was reported as drug withdrwan with respect to the event. Patient could not determine if it was from the vaccine or the Rinvoq. Patient stopped taking Rinvoq in Jul 2021 for about a month. She started back the Rinvoq on 31 Aug 2021 and would see if it came back or not. Primary reporter contact for lot number information was not available for the first regimen of Rinvoq.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for the event(s) of muscle pain in legs with RINVOQ(UPADACITINIB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Live follow-up received additional causality of co-suspect drug was updated to reasonable possibility from not provided and co-suspect drug stop date of second regimen was added.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak). At the time of the report, ASTHENIA (felt weak) had resolved.            No relevant concomitant medications were reported.   She got weak after the booster shot, she does not know the side effects she had but knows it is after the Moderna shot. She only knows she felt weak for several hours and then was fine.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site swelling
Clinical narrative: Got dose of Moderna/ arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Got dose of Moderna/ arm got swollen) in a 64-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 Psoriatic arthritis and Ulcerative colitis.    The patient's medical history was not reported.  Concomitant products included METHOTREXATE from November 2021 to an unknown date for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-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) Solution for injection in pre-filled pen. In 2021, the patient experienced VACCINATION SITE SWELLING (Got dose of Moderna/ arm got swollen). In 2021, VACCINATION SITE SWELLING (Got dose of Moderna/ arm got swollen) had resolved.            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 received in the Moderna were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain got worse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain got worse) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Joint pain. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Joint pain.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ARTHRALGIA (joint pain got worse). At the time of the report, ARTHRALGIA (joint pain got worse) outcome was unknown.            Patient reported that she missed XELJANZ doses for 4 weeks in feb-2021 and got Moderna Booster last week & as per MD she stopped taking the XELJANZ for 1 week after the vaccine and resumed therapy. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Incomplete course of vaccination
Clinical narrative: pretty bad severe allergic reaction; Incomplete course of vaccination; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (pretty bad severe allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (pretty bad severe allergic reaction) (seriousness criteria hospitalization and medically significant) and INCOMPLETE COURSE OF VACCINATION (Incomplete course of vaccination). At the time of the report, ANAPHYLACTIC REACTION (pretty bad severe allergic reaction) and INCOMPLETE COURSE OF VACCINATION (Incomplete course of vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported.  The patient received 1st dose of MODERNA COVID 19 vaccine in January 2021 , She had a pretty bad severe allergic reaction from the dose and was hospitalized. She was not able to get the 2nd dose due to severe reactions. She wants to complete the series to avoid discrimination and asking if she can have the 2nd dose as Pfizer. She spoke with the pharmacist and told her that she can still have the 2nd dose even if she had severe reactions   No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna  were missed to be booked-in.   This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced an expected, medically significant event of Anaphylactic reaction after receiving a 1st dose of mRNA-1273 vaccine that led to hospitalization. Exact onset latency of the event severe allergic reaction relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Patient did not receive a 2nd dose of mRNA-1273 vaccine due to severe reactions with the 1st dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced an expected, medically significant event of Anaphylactic reaction after receiving a 1st dose of mRNA-1273 vaccine that led to hospitalization. Exact onset latency of the event severe allergic reaction relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Patient did not receive a 2nd dose of mRNA-1273 vaccine due to severe reactions with the 1st dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dermatitis atopic, Erythema, Pruritus, Swelling
Clinical narrative: flareups after getting a covid-19 shot/ dermatitis re-appeared; skin redness; Itching; Swelling; This spontaneous case was reported by a patient and describes the occurrence of DERMATITIS ATOPIC (flareups after getting a covid-19 shot/ dermatitis re-appeared), ERYTHEMA (skin redness), PRURITUS (Itching) and SWELLING (Swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis.    The patient's past medical history included Atopic dermatitis.   In 2019, the patient started DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, DUPILUMAB (DUPIXENT) (unknown route) dosage was changed to at an unspecified dose. In 2021, the patient experienced DERMATITIS ATOPIC (flareups after getting a covid-19 shot/ dermatitis re-appeared), ERYTHEMA (skin redness), PRURITUS (Itching) and SWELLING (Swelling). At the time of the report, DERMATITIS ATOPIC (flareups after getting a covid-19 shot/ dermatitis re-appeared) had not resolved and ERYTHEMA (skin redness), PRURITUS (Itching) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's family history and concomitant medication were not provided.  It was mentioned that patient said she originally started on dupixent in 2019 and stopped taking the medication in 2020 after her atopic dermatitis got better. She restarted the medication after her dermatitis re-appeared after taking a COVID shot. Patient restarted dupixent on 29-Aug-2021. She said that her face has been more red and swollen. She also mentioned that she had gotten a sample of medication from her doctor's office. The last dose of medication was 09-Nov-2021. Patient was wondering if she should be taken her next injection and if it was common to have a flare up after taking a COVID injection.  It was not reported if the patient received a corrective treatment for the events.  It was mentioned that a product technical complaint was initiated on 16-Nov-2021 for dupilumab (lot/batch number: 1L135A, expiry date: 28-Feb-024) with global PTC number.  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: Pharyngeal mass, Procedural pain, Psoriasis
Clinical narrative: Some psorias has developed on hands and feet; Tooth pain after filling; Lump in throat; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Some psorias has developed on hands and feet), PROCEDURAL PAIN (Tooth pain after filling) and PHARYNGEAL MASS (Lump in throat) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe ).   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 PSORIASIS (Some psorias has developed on hands and feet), PROCEDURAL PAIN (Tooth pain after filling) and PHARYNGEAL MASS (Lump in throat). At the time of the report, PSORIASIS (Some psorias has developed on hands and feet), PROCEDURAL PAIN (Tooth pain after filling) and PHARYNGEAL MASS (Lump in throat) outcome was unknown.        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 Tooth pain after filling, Lump in throat and Some psorias has developed on hands and feet 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.
Age: 32.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: Fatigue; First dose on 18-Oct-2021 and Second dose on 09-Nov-2021; Patient was administered Moderna vaccine subcutaneously; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2021 and Second dose on 09-Nov-2021) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient was administered Moderna vaccine subcutaneously) in a 32-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 Crohn's disease.    No Medical History information was reported.   On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 18-Oct-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient was administered Moderna vaccine subcutaneously). On 09-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2021 and Second dose on 09-Nov-2021). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Oct-2021 and Second dose on 09-Nov-2021) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient was administered Moderna vaccine subcutaneously) outcome was unknown.            Concomitant drugs were not reported.  On 18-Oct-2021 and 09-Nov-2021, patient was administered Moderna vaccine subcutaneously (Inappropriate route of vaccination).  On unknown date, the patient experienced "taking over the counter mushrooms which was a natural" with Humira, it was not recovered/resolved yet.  On unknown date vaccine had caused fatigue.  Treatment medications were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity received in the Moderna  were missed to be booked-in.