chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Scar, Subcutaneous abscess, Vaccination site pain
Clinical narrative: Scarring under arm pit/groin area; Empty abscess under arm pit/abscess breast area/groin area; Soreness at first covid-19 shot; Leg muscle felt sore; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (Scarring under arm pit/groin area), SUBCUTANEOUS ABSCESS (Empty abscess under arm pit/abscess breast area/groin area), VACCINATION SITE PAIN (Soreness at first covid-19 shot) and MYALGIA (Leg muscle felt sore) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SCAR (Scarring under arm pit/groin area), SUBCUTANEOUS ABSCESS (Empty abscess under arm pit/abscess breast area/groin area), VACCINATION SITE PAIN (Soreness at first covid-19 shot) and MYALGIA (Leg muscle felt sore). At the time of the report, SCAR (Scarring under arm pit/groin area) and SUBCUTANEOUS ABSCESS (Empty abscess under arm pit/abscess breast area/groin area) had not resolved and VACCINATION SITE PAIN (Soreness at first covid-19 shot) and MYALGIA (Leg muscle felt sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of SORENESS AT FIRST COVID-19 SHOT, SCARRING UNDER ARM PIT/GROIN AREA, EMPTY ABSCESS UNDER ARM PIT/ABSCESS BREAST AREA/GROIN AREA and LEG MUSCLE FELT SORE with HUMIRA(ADALIMUMAB) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Headache, Immunisation reaction
Clinical narrative: Vaccination adverse reaction; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In November 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). In November 2021, IMMUNISATION REACTION (Vaccination adverse reaction), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.     Concomitant product use was not provided by the reporter.  In November 2021, the patient had a Moderna booster vaccine. He stated that approximately 12 hours later he experienced chills, headaches, and fatigue. He had no reaction to the first two vaccines. Lasted for approximately 24 hours.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's Causality for Rinvoq (Upadacitinib) for the events of reaction to covid vaccine booster, headaches, fatigue, and chills 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: 29.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Confusional state, Dizziness, Musculoskeletal discomfort, Pyrexia, Road traffic accident
Clinical narrative: Dizziness; Fever; Confused; Discomfort in joints; Motor cycling accident; This spontaneous case was reported by a consumer and describes the occurrence of ROAD TRAFFIC ACCIDENT (Motor cycling accident), DIZZINESS (Dizziness), MUSCULOSKELETAL DISCOMFORT (Discomfort in joints), PYREXIA (Fever) and CONFUSIONAL STATE (Confused) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 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. In May 2021, the patient experienced ROAD TRAFFIC ACCIDENT (Motor cycling accident) and MUSCULOSKELETAL DISCOMFORT (Discomfort in joints). On an unknown date, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever) and CONFUSIONAL STATE (Confused). At the time of the report, ROAD TRAFFIC ACCIDENT (Motor cycling accident) and MUSCULOSKELETAL DISCOMFORT (Discomfort in joints) had not resolved and DIZZINESS (Dizziness), PYREXIA (Fever) and CONFUSIONAL STATE (Confused) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine were provided. There was no reported medical history. For HUMIRA, the reporter causality for the events of Motorcycle accident was no reasonable possibility and for the events of Dizziness, Discomfort in wrist, Fever and Confused 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. No treatment medicine were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Accident at work, Blood iron decreased, Fatigue, Infusion related reaction, Pain
Clinical narrative: Injury at work; Had issues getting blood with veins during iron infusions; Infusion associated discomfort; Pain; Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT AT WORK (Injury at work), BLOOD IRON DECREASED (Had issues getting blood with veins during iron infusions), INFUSION RELATED REACTION (Infusion associated discomfort), PAIN (Pain) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received 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 ACCIDENT AT WORK (Injury at work), BLOOD IRON DECREASED (Had issues getting blood with veins during iron infusions), INFUSION RELATED REACTION (Infusion associated discomfort), PAIN (Pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ACCIDENT AT WORK (Injury at work), BLOOD IRON DECREASED (Had issues getting blood with veins during iron infusions) and FATIGUE (Fatigue) had not resolved, INFUSION RELATED REACTION (Infusion associated discomfort) outcome was unknown and PAIN (Pain) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.     Concomitant product use was not provided by the reporter.  The patient had issues getting blood with veins during iron infusions, fatigued, cut self at work, sore after covid-19 vaccine, iron being low, and arm hurt after covid booster with Humira (Adalimumab).   On unknown dates, the patient experienced had issues getting blood with veins during iron infusions, fatigued, cut self at work, sore after covid-19 vaccine, iron being low, and arm hurt after covid booster. on unknown dates, sore after covid-19 vaccine and arm hurt after covid booster resolved.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for Humira (Adalimumab) for the events of had issues getting blood with veins during iron infusions, fatigued, cut self at work, sore after covid-19 vaccine, iron being low, and arm hurt after covid booster causality was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injury at work; Had issues getting blood with veins during iron infusions; Infusion associated discomfort; Pain; Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT AT WORK (Injury at work), BLOOD IRON DECREASED (Had issues getting blood with veins during iron infusions), INFUSION RELATED REACTION (Infusion associated discomfort), PAIN (Pain) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received 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 ACCIDENT AT WORK (Injury at work), BLOOD IRON DECREASED (Had issues getting blood with veins during iron infusions), INFUSION RELATED REACTION (Infusion associated discomfort), PAIN (Pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ACCIDENT AT WORK (Injury at work), BLOOD IRON DECREASED (Had issues getting blood with veins during iron infusions) and FATIGUE (Fatigue) had not resolved, INFUSION RELATED REACTION (Infusion associated discomfort) outcome was unknown and PAIN (Pain) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.     Concomitant product use was not provided by the reporter.  The patient had issues getting blood with veins during iron infusions, fatigued, cut self at work, sore after covid-19 vaccine, iron being low, and arm hurt after covid booster with Humira (Adalimumab).   On unknown dates, the patient experienced had issues getting blood with veins during iron infusions, fatigued, cut self at work, sore after covid-19 vaccine, iron being low, and arm hurt after covid booster. on unknown dates, sore after covid-19 vaccine and arm hurt after covid booster resolved.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for Humira (Adalimumab) for the events of had issues getting blood with veins during iron infusions, fatigued, cut self at work, sore after covid-19 vaccine, iron being low, and arm hurt after covid booster causality was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 91.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Unevaluable event
Clinical narrative: Unevaluable event; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Surgery (The patient had a fissure and needed surgery in Apr-2021. He had a previous surgery in that area.). Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion medically significant). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) had resolved.            The patient had a fissure and needed surgery in Apr-2021. He had a previous surgery in that area. On an unknown date, the patient experienced FISSURE.. No concomitant medication information was reported. No treatment medication information was reported. Formulation of Humira was reported as Solution for injection in pre-filled pen.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns an elderly male patient aged 91 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Unevaluable event that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient had a fissure and needed surgery in April 2021. No further information on clinical course, investigations and treatment received was available in the report. Patient had received initial two doses of mRNA-1273 at an interval of 31 days. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly male patient aged 91 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Unevaluable event that occurred on an unknown date in the context of mRNA-1273 vaccination. Patient had a fissure and needed surgery in April 2021. No further information on clinical course, investigations and treatment received was available in the report. Patient had received initial two doses of mRNA-1273 at an interval of 31 days. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Colonoscopy, Diarrhoea
Clinical narrative: third covid 19 vaccine caused chills and diarrhea increased; third covid 19 vaccine caused chills and diarrhea increased; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (third covid 19 vaccine caused chills and diarrhea increased) and CHILLS (third covid 19 vaccine caused chills and diarrhea increased) in a 61-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 Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form 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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (third covid 19 vaccine caused chills and diarrhea increased) and CHILLS (third covid 19 vaccine caused chills and diarrhea increased). At the time of the report, DIARRHOEA (third covid 19 vaccine caused chills and diarrhea increased) had not resolved and CHILLS (third covid 19 vaccine caused chills and diarrhea increased) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: 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: M
Vaccine: COVID19, UNK
Symptoms: Illness, Pain in extremity
Clinical narrative: Soreness in hand; Got second vaccine for COVID and got sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in hand) and ILLNESS (Got second vaccine for COVID and got sick) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in hand) and ILLNESS (Got second vaccine for COVID and got sick). At the time of the report, PAIN IN EXTREMITY (Soreness in hand) had not resolved and ILLNESS (Got second vaccine for COVID and got sick) had resolved. No concomitant medication provided. No treatment information mentioned. Patient experienced soreness in hands on an unknown date. He got the second COVID vaccine and got sick for one week.  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, Injection site pain, Vaccination site reaction
Clinical narrative: Some side effect; Pain at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Some side effect), INJECTION SITE PAIN (Pain at injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Some side effect), INJECTION SITE PAIN (Pain at injection site) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE REACTION (Some side effect), INJECTION SITE PAIN (Pain at injection site) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Pyrexia, White blood cell count, White blood cell count increased
Clinical narrative: White blood cell count high; Fever; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product 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 On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second 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 WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and PYREXIA (Fever). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (White blood cell count high) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High and diagnosed with fever. On an unknown date, White blood cell count: High.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Patient had high white blood count. She had fever after third vaccine. The reported events were related to covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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: Psoriasis
Clinical narrative: Plaque psoriasis spots on left knee, above upper left thigh, left elbow and on tailbone; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis spots on left knee, above upper left thigh, left elbow and on tailbone) 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 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) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis spots on left knee, above upper left thigh, left elbow and on tailbone). At the time of the report, PSORIASIS (Plaque psoriasis spots on left knee, above upper left thigh, left elbow and on tailbone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient experienced possible lack of effect towards suspect Humira and got plaque psoriasis spots on left knee, above upper left thigh, left elbow and on tail bone.  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: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Back pain, Balance disorder, Fatigue, Pain
Clinical narrative: Balance disorder; Weakness generalised; Pain; Back pain; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness), BALANCE DISORDER (Balance disorder), ASTHENIA (Weakness generalised) and BACK PAIN (Back pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness) and BACK PAIN (Back pain). On 04-Oct-2021, the patient experienced PAIN (Pain). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder) and ASTHENIA (Weakness generalised). On 05-Oct-2021, PAIN (Pain) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness), BALANCE DISORDER (Balance disorder), ASTHENIA (Weakness generalised) and BACK PAIN (Back pain) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the events of Back pain, Tiredness, Balance disorder, Weakness generalized and pain was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.  Reporter did not allow further contact  Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Significant follow up contains New event PAIN, updated Moderna vaccine administration date and updated event causality with Moderna vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Balance disorder; Weakness generalised; Pain; Back pain; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness), BALANCE DISORDER (Balance disorder), ASTHENIA (Weakness generalised) and BACK PAIN (Back pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness) and BACK PAIN (Back pain). On 04-Oct-2021, the patient experienced PAIN (Pain). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder) and ASTHENIA (Weakness generalised). On 05-Oct-2021, PAIN (Pain) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness), BALANCE DISORDER (Balance disorder), ASTHENIA (Weakness generalised) and BACK PAIN (Back pain) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the events of Back pain, Tiredness, Balance disorder, Weakness generalized and pain was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.  Reporter did not allow further contact  Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Significant follow up contains New event PAIN, updated Moderna vaccine administration date and updated event causality with Moderna vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Skin reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN REACTION (Skin reaction) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Skin reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, SKIN REACTION (Skin reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. She had the moderna covid 19 vaccine on September and got a bad skin reaction to it. Her doctor told her to start the whole series over with the Pfizer Biontech COVID 19 vaccine instead so in november she got her first dose and she had the appointment for the second dose yesterday 27 Dec 2021. patient was not immunocompromised. She did not feel comfortable administering a third dose of covid vaccine to the patient. 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: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant and Treatment Drug was provided by reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin lesion
Clinical narrative: Two lesions on cheek; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Two lesions on cheek) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SKIN LESION (Two lesions on cheek). At the time of the report, SKIN LESION (Two lesions on cheek) had not resolved.            No concomitant medication provided. No treatment information mentioned.  Patient had two lesions, one on right cheek and the other on left for a week in 2021. Prescription was delayed due to this.   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: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, Cough, Nasal congestion, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Temperature was 100.8; Sneezing; Blowing his Nose; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), NASAL CONGESTION (Blowing his Nose), COUGH (Coughing) and PYREXIA (Temperature was 100.8) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016A201) for COVID-19 prophylaxis.    Co-suspect product included non-company product TAFAMIDIS (VYNDAMAX) capsule for an unknown indication.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient started TAFAMIDIS (VYNDAMAX) (unknown route) 61 milligram once a day. On 14-Oct-2021, the patient experienced SNEEZING (Sneezing), NASAL CONGESTION (Blowing his Nose) and COUGH (Coughing). On 15-Oct-2021, the patient experienced PYREXIA (Temperature was 100.8). At the time of the report, SNEEZING (Sneezing), NASAL CONGESTION (Blowing his Nose), COUGH (Coughing) and PYREXIA (Temperature was 100.8) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2021, Body temperature: 108. On an unknown date, SARS-CoV-2 antibody test: Results not available.   No concomitant medication details were provided.   Reporter stated that patient thinks, was not sure, but thinks, that he may have Covid.  Caller states she wonders if he should continue taking the medication, Vyndamax Caller states the patient started taking Vyndamax and he has had no reaction of any kind. He takes the medication after breakfast around 09:30 and he has no side effects. Patient was outside for a while, and he started sneezing and blowing his nose so caller thought maybe it was allergies. Caller states he woke up today and he was doing the same thing, so she took his temperature and it was 100.8 and it was a little lower than that before. Caller states he hasn't taken Tylenol or anything like that. Caller states she talked to her Sister, who is a nurse, and she said that no doctor was going to want to see him if he has those symptoms, unless he can verify that he doesn't have Covid.  Caller stated that he has had the Covid Shot and the Flu Shot and he had no reactions to those.  Caller stated he had the Moderna shot for the Covid. Caller states they went and got a test today and they should have those results within 24 hours or on Sunday. Caller states he is just a little tired.   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: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Sneezing
Clinical narrative: Temperature was 100.8; Sneezing; Blowing his Nose; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), NASAL CONGESTION (Blowing his Nose), COUGH (Coughing) and PYREXIA (Temperature was 100.8) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016A201) for COVID-19 prophylaxis.    Co-suspect product included non-company product TAFAMIDIS (VYNDAMAX) capsule for an unknown indication.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient started TAFAMIDIS (VYNDAMAX) (unknown route) 61 milligram once a day. On 14-Oct-2021, the patient experienced SNEEZING (Sneezing), NASAL CONGESTION (Blowing his Nose) and COUGH (Coughing). On 15-Oct-2021, the patient experienced PYREXIA (Temperature was 100.8). At the time of the report, SNEEZING (Sneezing), NASAL CONGESTION (Blowing his Nose), COUGH (Coughing) and PYREXIA (Temperature was 100.8) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2021, Body temperature: 108. On an unknown date, SARS-CoV-2 antibody test: Results not available.   No concomitant medication details were provided.   Reporter stated that patient thinks, was not sure, but thinks, that he may have Covid.  Caller states she wonders if he should continue taking the medication, Vyndamax Caller states the patient started taking Vyndamax and he has had no reaction of any kind. He takes the medication after breakfast around 09:30 and he has no side effects. Patient was outside for a while, and he started sneezing and blowing his nose so caller thought maybe it was allergies. Caller states he woke up today and he was doing the same thing, so she took his temperature and it was 100.8 and it was a little lower than that before. Caller states he hasn't taken Tylenol or anything like that. Caller states she talked to her Sister, who is a nurse, and she said that no doctor was going to want to see him if he has those symptoms, unless he can verify that he doesn't have Covid.  Caller stated that he has had the Covid Shot and the Flu Shot and he had no reactions to those.  Caller stated he had the Moderna shot for the Covid. Caller states they went and got a test today and they should have those results within 24 hours or on Sunday. Caller states he is just a little tired.   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, UNK
Symptoms: Ear infection, Sinusitis
Clinical narrative: Sinus infection; Ear infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) and EAR INFECTION (Ear infection) 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 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SINUSITIS (Sinus infection) and EAR INFECTION (Ear infection). At the time of the report, SINUSITIS (Sinus infection) and EAR INFECTION (Ear infection) had resolved.            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.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; received both doses of the Moderna covid vaccine 21 days apart back in April; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received both doses of the Moderna covid vaccine 21 days apart back in April) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received both doses of the Moderna covid vaccine 21 days apart back in April). 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 both doses of the Moderna covid vaccine 21 days apart back in April) and NO ADVERSE EVENT (No adverse event) 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, UNK
Symptoms: Headache, Injection site urticaria, Pain, Vaccination site pain
Clinical narrative: achy after covid vaccine; sore arm after covid vaccine; hives at injeciton site the day after the injection; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy after covid vaccine), VACCINATION SITE PAIN (sore arm after covid vaccine), INJECTION SITE URTICARIA (hives at injeciton site the day after the injection) and HEADACHE (headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (achy after covid vaccine), VACCINATION SITE PAIN (sore arm after covid vaccine), INJECTION SITE URTICARIA (hives at injeciton site the day after the injection) and HEADACHE (headache). At the time of the report, PAIN (achy after covid vaccine), VACCINATION SITE PAIN (sore arm after covid vaccine), INJECTION SITE URTICARIA (hives at injeciton site the day after the injection) and HEADACHE (headache) 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.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Adverse events that were noted as Minor; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Adverse events that were noted as Minor) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Adverse events that were noted as Minor). At the time of the report, IMMUNISATION REACTION (Adverse events that were noted as Minor) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, SARS-CoV-2 test, Sinusitis
Clinical narrative: she has a sinus infection and it has gone into her chest; had such a terrible reaction; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (she has a sinus infection and it has gone into her chest) and IMMUNISATION REACTION (had such a terrible reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (she has a sinus infection and it has gone into her chest) and IMMUNISATION REACTION (had such a terrible reaction). At the time of the report, SINUSITIS (she has a sinus infection and it has gone into her chest) and IMMUNISATION REACTION (had such a terrible reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient had such a terrible reaction and doctor advised her not to get the second one.  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: 57.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rash, Somnolence, Swollen tongue, Tongue discolouration, Vaccination complication
Clinical narrative: swollen tongue; Sleepiness; swollen tongue, with raised white puffy lines; vaccination complication; Rash; This spontaneous case was reported by a patient and describes the occurrence of SWOLLEN TONGUE (swollen tongue), SOMNOLENCE (Sleepiness), TONGUE DISCOLOURATION (swollen tongue, with raised white puffy lines), VACCINATION COMPLICATION (vaccination complication) and RASH (Rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Prophylactic vaccination.    No medial history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   In 2009, the patient received dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) (unknown route) .5 milliliter. 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 SWOLLEN TONGUE (swollen tongue), SOMNOLENCE (Sleepiness), TONGUE DISCOLOURATION (swollen tongue, with raised white puffy lines), VACCINATION COMPLICATION (vaccination complication) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SWOLLEN TONGUE (swollen tongue), SOMNOLENCE (Sleepiness), TONGUE DISCOLOURATION (swollen tongue, with raised white puffy lines), VACCINATION COMPLICATION (vaccination complication) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.