chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 30-Mar-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received First dose of Pfizer on 9th of March and on 30th of March, also received two doses of the Moderna vaccine on April 29th and May 26th).    Concomitant medication was not reported.  On 09-Mar-2021 patient received first dose of Pfizer vaccine and on 30-Mar-2021 received second dose. Again patient received Moderna vaccine on 29-Apr-2021 and 26-May-2021. Dose details were unknown. Treatment details were 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.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site bruising, Injection site haemorrhage, Vaccination site pain
Clinical narrative: Fatigue; Vaccination site pain; Headache; Injection site bruising; Injection site bleeding; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain), HEADACHE (Headache), INJECTION SITE BRUISING (Injection site bruising) and INJECTION SITE HAEMORRHAGE (Injection site bleeding) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain), HEADACHE (Headache), INJECTION SITE BRUISING (Injection site bruising) and INJECTION SITE HAEMORRHAGE (Injection site bleeding). At the time of the report, FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache) outcome was unknown and INJECTION SITE BRUISING (Injection site bruising) and INJECTION SITE HAEMORRHAGE (Injection site bleeding) had resolved.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was not available. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrointestinal disorder, Headache, Inappropriate schedule of product administration, Urinary tract disorder
Clinical narrative: Unspecified disorder of intestine; Uropathy; Feels bad; Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 36 days; Headache; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), URINARY TRACT DISORDER (Uropathy), FEELING ABNORMAL (Feels bad), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 36 days) and HEADACHE (Headache) in a 47-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 Crohn's disease.    Concurrent medical conditions included Crohn's disease aggravated.   On 15-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. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 36 days). In 2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), URINARY TRACT DISORDER (Uropathy) and FEELING ABNORMAL (Feels bad). At the time of the report, GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), URINARY TRACT DISORDER (Uropathy), FEELING ABNORMAL (Feels bad), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 36 days), HEADACHE (Headache) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.   On unknown dates, the patient experienced bowel issues, urine issues and it seemed like when took Humira felts good until the fifth or sixth day before next injection and next injection felts bad all over again. In 2021, the patient had two covid vaccine and had sore arm at injection site and had two covid vaccine and had headache. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Unspecified disorder of intestine; Uropathy; Feels bad; Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 36 days; Headache; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), URINARY TRACT DISORDER (Uropathy), FEELING ABNORMAL (Feels bad), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 36 days) and HEADACHE (Headache) in a 47-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 Crohn's disease.    Concurrent medical conditions included Crohn's disease aggravated.   On 15-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. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 36 days). In 2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), URINARY TRACT DISORDER (Uropathy) and FEELING ABNORMAL (Feels bad). At the time of the report, GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), URINARY TRACT DISORDER (Uropathy), FEELING ABNORMAL (Feels bad), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 36 days), HEADACHE (Headache) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.   On unknown dates, the patient experienced bowel issues, urine issues and it seemed like when took Humira felts good until the fifth or sixth day before next injection and next injection felts bad all over again. In 2021, the patient had two covid vaccine and had sore arm at injection site and had two covid vaccine and had headache. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third 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 FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, FATIGUE (Fatigue) outcome was unknown and ARTHRALGIA (Joint pain) was resolving.            Doctor told her to stop taking Rinvoq before taking booster injection for Covid 19. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold like symptoms after getting Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold like symptoms after getting Moderna booster) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    No Medical History information was reported.   On 11-Dec-2015, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram once a day. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient 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. On 05-Nov-2021, the patient experienced NASOPHARYNGITIS (Cold like symptoms after getting Moderna booster). At the time of the report, NASOPHARYNGITIS (Cold like symptoms after getting Moderna booster) was resolving.            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, Psoriasis
Clinical narrative: Flu like symptoms; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and PSORIASIS (Psoriasis flare-up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    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 28-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PSORIASIS (Psoriasis flare-up). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PSORIASIS (Psoriasis flare-up) was resolving.            No concomitant medication information was provided. The patient still got flair ups, she had caused mild flu like symptoms for a day. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: SPOTS ONCE COMPLETED THE COVID VACCINE MODERNA; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (SPOTS ONCE COMPLETED THE COVID VACCINE MODERNA) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    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) UNK, Citrate Free. On an unknown date, the patient experienced VACCINATION SITE REACTION (SPOTS ONCE COMPLETED THE COVID VACCINE MODERNA). At the time of the report, VACCINATION SITE REACTION (SPOTS ONCE COMPLETED THE COVID VACCINE MODERNA) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Stiffness; Pain; Pain in toes; Stiffness in hands in mornings; Minimal hip pain (P1 joint); This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain), PAIN IN EXTREMITY (Pain in toes), MUSCULOSKELETAL STIFFNESS (Stiffness in hands in mornings) and ARTHRALGIA (Minimal hip pain (P1 joint)) 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 Psoriatic arthritis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain), PAIN IN EXTREMITY (Pain in toes), MUSCULOSKELETAL STIFFNESS (Stiffness in hands in mornings) and ARTHRALGIA (Minimal hip pain (P1 joint)). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) and PAIN (Pain) outcome was unknown and PAIN IN EXTREMITY (Pain in toes), MUSCULOSKELETAL STIFFNESS (Stiffness in hands in mornings) and ARTHRALGIA (Minimal hip pain (P1 joint)) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. The reporter did not provide any causality assessment for the events of limbs stiffness, pain in toe and pain in hip with Humira. The reporter assessed the events of pain and stiffness to be not reasonably possible to Humira. The reporter did not provide any causality assessment for the events of limbs stiffness, pain in toe and pain in hip with Moderna vaccine. The reporter assessed the events of pain and stiffness to be possibly related to Moderna vaccine. 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: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) 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 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) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the event with Humira and assessed the event as not related to Moderna vaccine.  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: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Vaccination site pruritus/Itchiness at the inejction site after moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Vaccination site pruritus/Itchiness at the inejction site after moderna booster) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 in 10 D. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus/Itchiness at the inejction site after moderna booster). At the time of the report, VACCINATION SITE PRURITUS (Vaccination site pruritus/Itchiness at the inejction site after moderna booster) had resolved. Not Provided          No concomitant medications were reported.   On an unknown date, the patient experienced itchiness at the inejction site after Moderna booster. On an unknown date, itchiness at the inejction site after Moderna booster resolved. Moderna vaccine was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. On an unknown date, she received COVID-19 Vaccine manufactured by Moderna. On an unknown date, she received COVID-19 vaccine booster manufactured by Moderna.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Vaccination site urticaria
Clinical narrative: Psoriasis flare-up; Vaccination site urticaria; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and VACCINATION SITE URTICARIA (Vaccination site urticaria) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate to severe chronic plaque psoriasis).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE URTICARIA (Vaccination site urticaria). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). In 2021, VACCINATION SITE URTICARIA (Vaccination site urticaria) had resolved. At the time of the report, PSORIASIS (Psoriasis flare-up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  Concomitant medications details were not reported.  It was reported that the patient had flare up, bad reaction to covid vaccine broke out in hives in 2021. Patient's physician advised to not take second shot.   Primary reporter does not had the lot number information, because the packaging was discarded for Skyrizi.  The reporter's causality for the events of Vaccination site urticaria and Psoriasis flare-up was reported as Reasonable possibility for Skyrizi.  No treatment information 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.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Feeling abnormal, Hernia, Hernia pain, Hypertension
Clinical narrative: HERNIA ON CHEST; FEELING AWFUL; PAIN FROM THE HERNIA; High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HERNIA (HERNIA ON CHEST), FEELING ABNORMAL (FEELING AWFUL), HERNIA PAIN (PAIN FROM THE HERNIA) and HYPERTENSION (High blood pressure) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for 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 On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced HERNIA (HERNIA ON CHEST), FEELING ABNORMAL (FEELING AWFUL), HERNIA PAIN (PAIN FROM THE HERNIA) and HYPERTENSION (High blood pressure). At the time of the report, HERNIA (HERNIA ON CHEST), HERNIA PAIN (PAIN FROM THE HERNIA) and HYPERTENSION (High blood pressure) had not resolved and FEELING ABNORMAL (FEELING AWFUL) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High.         No concomitant and treatment 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: Immunisation reaction, Product administered to patient of inappropriate age
Clinical narrative: Vaccination related malaise; Vaccine administered to patient of adolescent male patient; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination related malaise) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient of adolescent male patient) in an adolescent 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.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination related malaise) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient of adolescent male patient). At the time of the report, IMMUNISATION REACTION (Vaccination related malaise) was resolving and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to patient of adolescent male patient) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On an unknown date, the patient experienced did not feel well from covid Injection. Moderna vaccine was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Moderna.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain, SARS-CoV-2 antibody test
Clinical narrative: Inflammation; Pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) and PAIN (Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    Concomitant products included PREDNISONE for an unknown indication.   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 INFLAMMATION (Inflammation) and PAIN (Pain). At the time of the report, INFLAMMATION (Inflammation) and PAIN (Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown dates, the patient experienced inflammation and it was systemic so deals with it all in body, slept twenty hours because it was the only thing. Patient do to bear pain was dealing with and had all three covid vaccines still had no antibodies in system. Moderna vaccine was also considered suspect.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  On an unknown date, patient received covid-19 vaccine manufactured moderna.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Psoriasis
Clinical narrative: Cold; Psoriasis flare-up; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PSORIASIS (Psoriasis flare-up) and PAIN IN EXTREMITY (Pain in arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    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 29-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and PSORIASIS (Psoriasis flare-up). At the time of the report, NASOPHARYNGITIS (Cold) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown and PSORIASIS (Psoriasis flare-up) had not resolved.            The patient experienced sore arm after second moderna vaccine shot. Skyrizi lost strength after six weeks and patient had break out on various places on the body. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information 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: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) 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 Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Generalized aching; Tiredness; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 30-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 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 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. On 09-Sep-2021, the patient experienced PAIN (Generalized aching), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (Generalized aching), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events with Humira.  The reporter assessed all the events as probably related to the Moderna vaccine.  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-2021-623900 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication information was provided. Patient states she had fatigue and sore arm after her moderna covid-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness at injection site; Swelling at injection site; Dose-1 on 28-AUG-2021 Dose-2 on 13-SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 on 28-AUG-2021 Dose-2 on 13-SEP-2021), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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) Citrate free. On 13-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 on 28-AUG-2021 Dose-2 on 13-SEP-2021). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 on 28-AUG-2021 Dose-2 on 13-SEP-2021) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved with sequelae.            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: Arthralgia, Dizziness, Joint dislocation
Clinical narrative: Joint dislocation/hip popped out of socket and it popped back in when stood up; Felt faint; Shoulder pain/left shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT DISLOCATION (Joint dislocation/hip popped out of socket and it popped back in when stood up), DIZZINESS (Felt faint) and ARTHRALGIA (Shoulder pain/left shoulder pain) 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 Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced JOINT DISLOCATION (Joint dislocation/hip popped out of socket and it popped back in when stood up), DIZZINESS (Felt faint) and ARTHRALGIA (Shoulder pain/left shoulder pain). At the time of the report, JOINT DISLOCATION (Joint dislocation/hip popped out of socket and it popped back in when stood up) had resolved and DIZZINESS (Felt faint) and ARTHRALGIA (Shoulder pain/left shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On unknown dates, the patient experienced hip popped out of socket, almost passed out and it popped back in when stood up and left shoulder pain. Covid-19 vaccine  Moderna vaccine was also considered suspect.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.  The patient's past medical history included Anxiety and Depression.  On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.     No concomitant medication information was reported. No treatment medication information was reported. In Jun-2021, the patient experienced exacerbation of anxiety and depression and in Aug-2021, the patient experienced fever. Patient had Electrical stimulation therapy. 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-2021-624195.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bone scan, Fall, Immunisation reaction, Ultrasound Doppler
Clinical narrative: Vaccination adverse reaction; Fell; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell) and IMMUNISATION REACTION (Vaccination adverse reaction) in a 63-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) tablet for Rheumatoid arthritis.    The patient's past medical history included Ex-alcohol user (DRINKS WHISKEY, BOURBON AND RHUM EVERYDAY FOR AT LEAST TWO GLASSES) from 1973 to 1983. Concurrent medical conditions included Type II diabetes mellitus, Nodule, Allergy to animal dander (CAT HAIR ALLERGY MANIFESTATED BY HIVES), Tobacco user (A PACK OF CIGARETTE A DAY) since 1973, Anxiety, Blood cholesterol abnormal, Rheumatoid arthritis, Liver disorder and Panic attacks. Concomitant products included AMITRIPTYLINE for Anxiety, ALPRAZOLAM (XANAX) for Anxiety and Panic attacks, EZETIMIBE and ROSUVASTATIN for Blood cholesterol abnormal, FOLIC ACID for Liver disorder, METHOTREXATE for Rheumatoid arthritis, INSULIN DETEMIR (LEVEMIR), INSULIN ASPART, EMPAGLIFLOZIN (JARDIANCE) and GLIMEPIRIDE for Type II diabetes mellitus.   In 2019, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FALL (Fell). On 01-Feb-2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). In 2021, IMMUNISATION REACTION (Vaccination adverse reaction) had resolved. At the time of the report, FALL (Fell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Ultrasound Doppler: Poor blood circulation in legs. On 16-Dec-2021, Bone scan: Result not reported.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of covid vaccination reaction after first dose and Fell with RINVOQ(UPADACITINIB) was no reasonable possibility.  Treatment medications were 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.   This case was linked to MOD-2021-624168 (Patient Link).   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: felt super tired; Sore arm after received covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after received covid vaccine) and FATIGUE (felt super tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm after received covid vaccine). In September 2021, the patient experienced FATIGUE (felt super tired). In 2021, VACCINATION SITE PAIN (Sore arm after received covid vaccine) had resolved. At the time of the report, FATIGUE (felt super tired) had not resolved.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624295 (Patient Link).