chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa. No Medical History information was reported. On 22-Jul-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) at an unspecified dose. On 23-Sep-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving. It was unknown if patient was enrolled in a COVID-19 vaccine trial. 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. Company comment: This is a spontaneous case reported by a consumer, concerning a 42-year-old female patient with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 approximately 2 months after receiving the second dose of mRNA-1273 Vaccine in the Covid 19 vaccination series. Patient previously received the 1 dose  of mRNA1273 vaccine on an unknown date. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for Hidradenitis suppurativa, Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of Covid 19 was resolving. Ongoing Covid 19 pandemia and use of Adalimumab could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 42-year-old female patient with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 approximately 2 months after receiving the second dose of mRNA-1273 Vaccine in the Covid 19 vaccination series. Patient previously received the 1 dose  of mRNA1273 vaccine on an unknown date. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for Hidradenitis suppurativa, Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of Covid 19 was resolving. Ongoing Covid 19 pandemia and use of Adalimumab could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Seasonal affective disorder
Clinical narrative: Seasonal depression; Not feel well; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL AFFECTIVE DISORDER (Seasonal depression) and MALAISE (Not feel well) 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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-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 SEASONAL AFFECTIVE DISORDER (Seasonal depression) and MALAISE (Not feel well). At the time of the report, SEASONAL AFFECTIVE DISORDER (Seasonal depression) and MALAISE (Not feel well) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Therapeutic product effect decreased
Clinical narrative: Flu like symptoms; Drug effect decreased; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) 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 Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patient reported events of non-serious lack of effect / humira was no longer working and flu like symptoms with HUMIRA (ADALIMUMAB).  On unknown dates, the patient experienced lack of effect/humira was no longer working and flu like symptoms. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of lack of effect/humira was no longer working and flu like symptoms was not provided.  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: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills
Clinical narrative: Chills; Chills; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CHILLS (Chills) and the second episode of CHILLS (Chills) 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) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received 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) at an unspecified dose. In 2021, the patient experienced the first episode of CHILLS (Chills). On 05-Nov-2021, the patient experienced the second episode of CHILLS (Chills). On 06-Nov-2021, last episode of CHILLS (Chills) had resolved. 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 03-Dec-2021: Suspect booster regimen added. Chill after booster dose added as event.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Burning at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burning at injection site) 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 VACCINATION SITE PAIN (Burning at injection site). At the time of the report, VACCINATION SITE PAIN (Burning at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 vaccine trial. 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), HEADACHE (Headache) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced MALAISE (Feeling sick), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, MALAISE (Feeling sick), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. It was unknown if patient was enrolled in a COVID-19 vaccine trial. 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. This case was linked to MOD-2021-624364 (Patient Link).
Sex: U
Vaccine: COVID19, UNK
Symptoms: Impaired healing, Pain in extremity
Clinical narrative: Slow healing/difficulties with sores healing; Sore places on finger and leg; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED HEALING (Slow healing/difficulties with sores healing) and PAIN IN EXTREMITY (Sore places on finger and leg) in an adult patient of an unknown gender 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-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) Citrate free. On an unknown date, the patient experienced IMPAIRED HEALING (Slow healing/difficulties with sores healing) and PAIN IN EXTREMITY (Sore places on finger and leg). At the time of the report, IMPAIRED HEALING (Slow healing/difficulties with sores healing) and PAIN IN EXTREMITY (Sore places on finger and leg) had not resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Swelling in both knees after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in both knees after vaccination) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form 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. On an unknown date, the patient experienced JOINT SWELLING (Swelling in both knees after vaccination). At the time of the report, JOINT SWELLING (Swelling in both knees after vaccination) was resolving.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Illness, Lymphadenopathy, Mobility decreased
Clinical narrative: Sickness; Mobility decreased; Psoriasis flare-up; Chills; Lymphadenopathy axillary; Tiredness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), MOBILITY DECREASED (Mobility decreased), PSORIASIS (Psoriasis flare-up), CHILLS (Chills) and LYMPHADENOPATHY (Lymphadenopathy axillary) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concomitant products included METHOTREXATE for an unknown indication.   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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness), MOBILITY DECREASED (Mobility decreased), PSORIASIS (Psoriasis flare-up), CHILLS (Chills), LYMPHADENOPATHY (Lymphadenopathy axillary), FATIGUE (Tiredness) and PYREXIA (Fever). At the time of the report, ILLNESS (Sickness) had resolved, MOBILITY DECREASED (Mobility decreased), CHILLS (Chills), LYMPHADENOPATHY (Lymphadenopathy axillary), FATIGUE (Tiredness) and PYREXIA (Fever) was resolving and PSORIASIS (Psoriasis flare-up) outcome 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 treatment medication was provided.   This case was linked to MOD-2021-624374.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Pyrexia
Clinical narrative: Sickness; Mobility decreased; Psoriasis flare-up; Chills; Lymphadenopathy axillary; Tiredness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), MOBILITY DECREASED (Mobility decreased), PSORIASIS (Psoriasis flare-up), CHILLS (Chills) and LYMPHADENOPATHY (Lymphadenopathy axillary) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concomitant products included METHOTREXATE for an unknown indication.   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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness), MOBILITY DECREASED (Mobility decreased), PSORIASIS (Psoriasis flare-up), CHILLS (Chills), LYMPHADENOPATHY (Lymphadenopathy axillary), FATIGUE (Tiredness) and PYREXIA (Fever). At the time of the report, ILLNESS (Sickness) had resolved, MOBILITY DECREASED (Mobility decreased), CHILLS (Chills), LYMPHADENOPATHY (Lymphadenopathy axillary), FATIGUE (Tiredness) and PYREXIA (Fever) was resolving and PSORIASIS (Psoriasis flare-up) outcome 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 treatment medication was provided.   This case was linked to MOD-2021-624374.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Inflammation, Pain
Clinical narrative: Inflammation; Pain; On 02 Jul 2021, patient received 1st dose and on 08 Aug 2021, patient received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), PAIN (Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 02 Jul 2021, patient received 1st dose and on 08 Aug 2021, patient received 2nd dose) in a 45-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 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-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) CF. On an unknown date, the patient experienced INFLAMMATION (Inflammation), PAIN (Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 02 Jul 2021, patient received 1st dose and on 08 Aug 2021, patient received 2nd dose). At the time of the report, INFLAMMATION (Inflammation) and PAIN (Pain) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 02 Jul 2021, patient received 1st dose and on 08 Aug 2021, patient received 2nd dose) outcome was unknown.            Concomitant products were not provided. Treatment medication were not 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Herpes zoster
Clinical narrative: Shingles; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and COVID-19 (COVID-19) 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.    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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced HERPES ZOSTER (Shingles) and COVID-19 (COVID-19). At the time of the report, HERPES ZOSTER (Shingles) and COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  On an unknown date, patient experienced Shingles and COVID-19. The patient had a breakthrough case of covid after being vaccinated. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dysgeusia, Osteoporosis, Spinal fracture, Vaccination site pain
Clinical narrative: Broken or cracked back; Terrible sandpaper taste in mouth; Bones was thinning out; Sore arm from COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL FRACTURE (Broken or cracked back) in a 55-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 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Sore arm from COVID-19 vaccine). On an unknown date, the patient experienced SPINAL FRACTURE (Broken or cracked back) (seriousness criterion medically significant), DYSGEUSIA (Terrible sandpaper taste in mouth) and OSTEOPOROSIS (Bones was thinning out). At the time of the report, SPINAL FRACTURE (Broken or cracked back), DYSGEUSIA (Terrible sandpaper taste in mouth), OSTEOPOROSIS (Bones was thinning out) and VACCINATION SITE PAIN (Sore arm from COVID-19 vaccine) outcome was unknown.            It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  No concomitant product reported by reporter. No treatment medication 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.  Company Comment: This is a spontaneous case concerning a 55-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Spinal fracture, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Spinal fracture, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) 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.   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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) had resolved.            Concomitant medication was not reported.  The patient was sick for a few days after taking the Moderna COVID booster. Patient received all three doses of vaccine from Moderna. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: Inappropriate schedule of vaccine administered; Flare up of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Flare up of pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 59-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 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 03-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In September 2021, the patient experienced PAIN (Flare up of pain). In September 2021, PAIN (Flare up of pain) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant medication was not reported.  Patient had a flare up of pain after taking her 2nd covid vaccine. Treatment details were not 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: RASH ON THE LEG; This spontaneous case was reported by a consumer and describes the occurrence of RASH (RASH ON THE LEG) 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.    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 RASH (RASH ON THE LEG). At the time of the report, RASH (RASH ON THE LEG) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  On an unknown date, patient experienced rash on leg after vaccination. Treatment details were not 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.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: The side effect she had, she had the moderna; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (The side effect she had, she had the moderna) 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 IMMUNISATION REACTION (The side effect she had, she had the moderna). At the time of the report, IMMUNISATION REACTION (The side effect she had, she had the moderna) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication details were provided. No treatment medication details were provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: 1st shot I took was Moderna and the 2nd shot was; 1st shot I took was Moderna and the 2nd shot was; No Adverse event; This spontaneous case was reported by a patient and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st shot I took was Moderna and the 2nd shot was), COVID-19 IMMUNISATION (1st shot I took was Moderna and the 2nd shot was) and NO ADVERSE EVENT (No Adverse event) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st shot I took was Moderna and the 2nd shot was), COVID-19 IMMUNISATION (1st shot I took was Moderna and the 2nd shot was) and NO ADVERSE EVENT (No Adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st shot I took was Moderna and the 2nd shot was), COVID-19 IMMUNISATION (1st shot I took was Moderna and the 2nd shot was) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pruritus
Clinical narrative: leg and foot cramps; skin itching all over/itchy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (leg and foot cramps) and PRURITUS (skin itching all over/itchy) in an 83-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) injection for Asthma.    Concurrent medical conditions included Asthma.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) 1 day. On an unknown date, the patient experienced MUSCLE SPASMS (leg and foot cramps) and PRURITUS (skin itching all over/itchy). At the time of the report, MUSCLE SPASMS (leg and foot cramps) and PRURITUS (skin itching all over/itchy) was resolving.            Concomitant products were not provided. Treatment medication were not reported. Consumer reports leg cramps and foot cramps, skin itching all over after starting Dupixent. 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: COVID-19
Clinical narrative: I was diagnosed with COVID-19 yesterday, December 17; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I was diagnosed with COVID-19 yesterday, December 17) 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 17-Dec-2021, the patient experienced COVID-19 (I was diagnosed with COVID-19 yesterday, December 17). At the time of the report, COVID-19 (I was diagnosed with COVID-19 yesterday, December 17) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    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, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication 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. No treatment medication was provided.  Company comment  This is a spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19, unknown days after  receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Patient previously received a dose of Pfizer vaccine and a dose of Janssen vaccines on unknown dates. Interchange of vaccine products was noted. Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was unknown. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19, unknown days after  receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Patient previously received a dose of Pfizer vaccine and a dose of Janssen vaccines on unknown dates. Interchange of vaccine products was noted. Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of covid 19 was unknown. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile colitis
Clinical narrative: colitis difficile (c-diff); This spontaneous case was reported by a consumer and describes the occurrence of CLOSTRIDIUM DIFFICILE COLITIS (colitis difficile (c-diff)) 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 CLOSTRIDIUM DIFFICILE COLITIS (colitis difficile (c-diff)) (seriousness criterion medically significant). At the time of the report, CLOSTRIDIUM DIFFICILE COLITIS (colitis difficile (c-diff)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported.  Treatment details 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.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Clostridium difficile colitis, which occurred after an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Clostridium difficile colitis, which occurred after an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, Headache, Hot flush, Pyrexia
Clinical narrative: Flashes after COVID-19 vaccine; Headache after COVID-19 vaccine; Fever after COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Flashes after COVID-19 vaccine), HEADACHE (Headache after COVID-19 vaccine) and PYREXIA (Fever after COVID-19 vaccination) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 27-Feb-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. In 2021, the patient experienced HOT FLUSH (Flashes after COVID-19 vaccine), HEADACHE (Headache after COVID-19 vaccine) and PYREXIA (Fever after COVID-19 vaccination). At the time of the report, HOT FLUSH (Flashes after COVID-19 vaccine), HEADACHE (Headache after COVID-19 vaccine) and PYREXIA (Fever after COVID-19 vaccination) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Good on antibodies.         No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events was not related with Humira. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of 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 ADALIMUMAB (HUMIRA) solution for injection 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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. It was reported that pain returned when dose was missed. 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 where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Limb operation, Pain in extremity
Clinical narrative: surgery on leg; Pain in other leg; This spontaneous case was reported by a consumer and describes the occurrence of LIMB OPERATION (surgery on leg) in a 63-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 UPADACITINIB (RINVOQ) 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced LIMB OPERATION (surgery on leg) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in other leg). At the time of the report, LIMB OPERATION (surgery on leg) was resolving and PAIN IN EXTREMITY (Pain in other leg) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown dates, the patient had surgery on leg. The patient was recovering from surgery on her leg. 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.  Company comment: This spontaneous case concerns a 63-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of limb operation an unknown time after a dose of mRNA-1273. The medical history of rheumatoid arthritis could be a risk factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as recovering. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of limb operation an unknown time after a dose of mRNA-1273. The medical history of rheumatoid arthritis could be a risk factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as recovering. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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) 40 milligram. On 20-Sep-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) outcome was unknown.            No concomitant 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 No treatment information was reported.