chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Lower respiratory tract infection, SARS-CoV-2 test
Clinical narrative: Chest infection; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and LOWER RESPIRATORY TRACT INFECTION (Chest infection) in a 65-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 Small lymphocytic lymphoma (Nodal marginal zone B-cell lymphoma) (Working Formulation).    The patient's past medical history included Chemotherapy and Thoracic duct ligation (Procedure done to repair the ruptured thoracic duct in the lungs).   On 01-Oct-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Chest infection). At the time of the report, COVID-19 (COVID-19) and LOWER RESPIRATORY TRACT INFECTION (Chest infection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         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: Erythema, Pruritus, Rash
Clinical narrative: Redness and rash on skin; Itching after 1 week; Rash on skn; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness and rash on skin), PRURITUS (Itching after 1 week) and RASH (Rash on skn) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ERYTHEMA (Redness and rash on skin), PRURITUS (Itching after 1 week) and RASH (Rash on skn). At the time of the report, ERYTHEMA (Redness and rash on skin), PRURITUS (Itching after 1 week) and RASH (Rash on skn) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient had no allergy to any food or drug and was healthy.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Vaccination site warmth; Tiredness; Vaccination site rash; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), FATIGUE (Tiredness), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    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 July 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) (unknown route) UNK, CF. In 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), FATIGUE (Tiredness), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), FATIGUE (Tiredness), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.            No concomitant and treatment medications were reported. It was reported that daily dose of Humira was citrate free. 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and MYALGIA (Body aches) 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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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) CF, UNK. On an unknown date, the patient experienced FATIGUE (Fatigue) and MYALGIA (Body aches). At the time of the report, FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. It was reported that reporter accidentally submitted an adverse event report to pfizer instead of moderna. The patient actually received the moderna vaccine. No treatment medication were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Embolism
Clinical narrative: Thromboembolic event; This spontaneous case was reported by a consumer and describes the occurrence of EMBOLISM (Thromboembolic event) 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 EMBOLISM (Thromboembolic event) (seriousness criterion medically significant). At the time of the report, EMBOLISM (Thromboembolic event) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Thromboembolic events in younger females exposed to Pfizer Bion Tech Covid 19 vaccines or  Moderna COVID-19 vaccines. No Concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comments  This is a spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious, medically significant AESI of EMBOLISM (Thromboembolic event), unknown days after receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. The report concerns about Thromboembolic events in younger females exposed to Moderna COVID-19 vaccines. Details of risk factors, other co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious, medically significant AESI of EMBOLISM (Thromboembolic event), unknown days after receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. The report concerns about Thromboembolic events in younger females exposed to Moderna COVID-19 vaccines. Details of risk factors, other co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Enzyme level increased, Enzyme level test
Clinical narrative: patient experienced ENZYMES UP; This spontaneous case was reported by a consumer and describes the occurrence of ENZYME LEVEL INCREASED (patient experienced ENZYMES UP) 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) solution for injection for an unknown indication.    No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced ENZYME LEVEL INCREASED (patient experienced ENZYMES UP). At the time of the report, ENZYME LEVEL INCREASED (patient experienced ENZYMES UP) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Enzyme level test: Enzyme level increased.         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: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash, Retching
Clinical narrative: Dry heaves; Loose yellow bowels; Rash on left arm, stomach, under breast; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (Dry heaves), DIARRHOEA (Loose yellow bowels) and RASH (Rash on left arm, stomach, under breast) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   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 RETCHING (Dry heaves), DIARRHOEA (Loose yellow bowels) and RASH (Rash on left arm, stomach, under breast). At the time of the report, RETCHING (Dry heaves) and RASH (Rash on left arm, stomach, under breast) had resolved and DIARRHOEA (Loose yellow bowels) 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.  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: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Stress
Clinical narrative: Condition aggravated; Stress; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated) and STRESS (Stress) in a 31-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 Psoriatic arthritis, Ankylosing spondylitis and Plaque psoriasis.    No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-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 CONDITION AGGRAVATED (Condition aggravated) and STRESS (Stress). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) and STRESS (Stress) outcome was unknown.            No concomitant medications was reported.  On unknown dates, the patient experienced flare up after went through stressing events in life and covid vaccine caused bad reaction/ flare up developed worst condition.  No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Inappropriate schedule of product administration, Peripheral swelling, Vaccination site pain
Clinical narrative: Low back pain; HANDS SWOLLEN; Injection site burning; LEFT HIP PAIN; 2nd dose of moderna vaccine taken on 01 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Low back pain), PERIPHERAL SWELLING (HANDS SWOLLEN), VACCINATION SITE PAIN (Injection site burning), ARTHRALGIA (LEFT HIP PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of moderna vaccine taken on 01 Feb 2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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) (unknown route) UNK, CF. On 01-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of moderna vaccine taken on 01 Feb 2021). On an unknown date, the patient experienced BACK PAIN (Low back pain), PERIPHERAL SWELLING (HANDS SWOLLEN), VACCINATION SITE PAIN (Injection site burning) and ARTHRALGIA (LEFT HIP PAIN). At the time of the report, BACK PAIN (Low back pain), PERIPHERAL SWELLING (HANDS SWOLLEN), VACCINATION SITE PAIN (Injection site burning), ARTHRALGIA (LEFT HIP PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of moderna vaccine taken on 01 Feb 2021) outcome was unknown.            No concomitant or treatment medication provided There was no reason possibility of events with HUMIRA This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Device issue, Pyrexia
Clinical narrative: Humira pen misfire and the medicine dribbled outside leg with humira (adalimumab); Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and DEVICE ISSUE (Humira pen misfire and the medicine dribbled outside leg with humira (adalimumab)) in a 69-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 Colitis ulcerative.    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. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, CF. In 2021, the patient experienced PYREXIA (Low grade fever). On an unknown date, the patient experienced DEVICE ISSUE (Humira pen misfire and the medicine dribbled outside leg with humira (adalimumab)). In 2021, PYREXIA (Low grade fever) had resolved. At the time of the report, DEVICE ISSUE (Humira pen misfire and the medicine dribbled outside leg with humira (adalimumab)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: Low grade fever.         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
Clinical narrative: Vaccination adverse reactions; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reactions). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. It was reported that patient experienced some adverse reactions with the Moderna vaccine.  The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Nasopharyngitis, Throat irritation
Clinical narrative: Dry spots on the ankles; Scratchy throat; Cold-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry spots on the ankles), THROAT IRRITATION (Scratchy throat) and NASOPHARYNGITIS (Cold-like symptoms) in a 52-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.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In May 2021, the patient received second 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 THROAT IRRITATION (Scratchy throat) and NASOPHARYNGITIS (Cold-like symptoms). On an unknown date, the patient experienced DRY SKIN (Dry spots on the ankles). At the time of the report, DRY SKIN (Dry spots on the ankles) outcome was unknown and THROAT IRRITATION (Scratchy throat) and NASOPHARYNGITIS (Cold-like symptoms) had resolved.            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: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Herpes zoster
Clinical narrative: COVID-19; Shingles; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and HERPES ZOSTER (Shingles) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and HERPES ZOSTER (Shingles). At the time of the report, COVID-19 (COVID-19) was resolving and HERPES ZOSTER (Shingles) had resolved.            No concomitant product was reported. Patient stated that when she started Rinvoq she got the shingles, she thought COVID caused more fatigue even after recovery. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Sore arm with vaccine; A bit of body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm with vaccine) and MYALGIA (A bit of body aches) in a 28-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 Ankylosing spondylitis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-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) CF. In 2021, the patient experienced VACCINATION SITE PAIN (Sore arm with vaccine) and MYALGIA (A bit of body aches). In 2021, VACCINATION SITE PAIN (Sore arm with vaccine) and MYALGIA (A bit of body aches) had 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.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Synovial cyst
Clinical narrative: Ganglion cyst on right hand; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (Ganglion cyst on right hand) 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 an unknown indication.    No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-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 SYNOVIAL CYST (Ganglion cyst on right hand). At the time of the report, SYNOVIAL CYST (Ganglion cyst on right hand) had not resolved.            No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality for the event(s) of GANGLION CYST ON RIGHT HAND with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: FELT REALLY TIRED; Headaches; Nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (FELT REALLY TIRED), HEADACHE (Headaches), NAUSEA (Nausea) and PAIN IN EXTREMITY (Sore arm) 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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced FATIGUE (FELT REALLY TIRED), HEADACHE (Headaches), NAUSEA (Nausea) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (FELT REALLY TIRED), HEADACHE (Headaches), NAUSEA (Nausea) and PAIN IN EXTREMITY (Sore arm) had resolved.            No concomitant and treatment medications provided. There was no reasonable possibility of events with Humira. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not 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.  Company Comment: This spontaneous case concerns a 49-year-old, female patient with a concurrent condition of psoriatic arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with an unknown event's onset date. Interval between doses 1 and 2 was 34 days apart. Outcome of the event was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying condition of psoriatic arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 49-year-old, female patient with a concurrent condition of psoriatic arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with an unknown event's onset date. Interval between doses 1 and 2 was 34 days apart. Outcome of the event was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying condition of psoriatic arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Muscular weakness, Psoriasis, Skin exfoliation
Clinical narrative: Flaking skin; Arthritis aggravated symptoms overall/ hips, shoulders; Psoriasis developing on the scalp; Weakness in extremity/Weakness in the hands, forearms; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Flaking skin), ARTHRITIS (Arthritis aggravated symptoms overall/ hips, shoulders), PSORIASIS (Psoriasis developing on the scalp) and MUSCULAR WEAKNESS (Weakness in extremity/Weakness in the hands, forearms) 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 Plaque psoriasis.    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 SKIN EXFOLIATION (Flaking skin), ARTHRITIS (Arthritis aggravated symptoms overall/ hips, shoulders), PSORIASIS (Psoriasis developing on the scalp) and MUSCULAR WEAKNESS (Weakness in extremity/Weakness in the hands, forearms). At the time of the report, SKIN EXFOLIATION (Flaking skin) and PSORIASIS (Psoriasis developing on the scalp) was resolving, ARTHRITIS (Arthritis aggravated symptoms overall/ hips, shoulders) had not resolved and MUSCULAR WEAKNESS (Weakness in extremity/Weakness in the hands, forearms) outcome was unknown.        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 medication information was provided.  Primary reporter contact for lot number information was unsuccessful.   The reporter's causality for the event(s) of FLAKY SKIN, PSORIASIS DEVELOPING ON THE SCALP and WEAKNESS IN THE HANDS, FOREARMS was not provided. The reporter's causality for the event(s) of INCREASED ARTHRITIS SYMPTOMS OVERALL/HIPS, SHOULDERS with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, SARS-CoV-2 test: positive, positive and positive.         The patient had not taken medications at all. He was active.  The patient had no taste or no smell. He was exposed to someone at work that had COVID.  This case was identified as part of a r etrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 59-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 6 days after receiving the third (booster) dose of the mRNA-1273 vaccine. It was reported that the patient was at 90% normal and had no taste or no smell. The patient tested positive for SARS-CoV-2 twice via COVID-19 rapid antigen tests and once via Polymerase Chain Reaction test. Treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: Live Follow Up Appended. Patient demographics added. On 17-Jan-2022: Live follow up - Moderna suspect dose details and laboratory test date added.; Sender's Comments: This spontaneous case concerns a 59-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 6 days after receiving the third (booster) dose of the mRNA-1273 vaccine. It was reported that the patient was at 90% normal and had no taste or no smell. The patient tested positive for SARS-CoV-2 twice via COVID-19 rapid antigen tests and once via Polymerase Chain Reaction test. Treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site swelling
Clinical narrative: Swelling in arm/Bump after COVID booster vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling in arm/Bump after COVID booster vaccine) 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.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling in arm/Bump after COVID booster vaccine). At the time of the report, VACCINATION SITE SWELLING (Swelling in arm/Bump after COVID booster vaccine) was resolving.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-091154, MOD-2021-624453 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Osteoporosis
Clinical narrative: Osteoporosis; Sick with covid booster shot; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOPOROSIS (Osteoporosis) and ILLNESS (Sick with covid booster shot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced ILLNESS (Sick with covid booster shot). On an unknown date, the patient experienced OSTEOPOROSIS (Osteoporosis). At the time of the report, OSTEOPOROSIS (Osteoporosis) was resolving and ILLNESS (Sick with covid booster shot) outcome 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site 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 Rheumatoid arthritis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.   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 VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided          On an unknown date, the patient experienced Injection site pain from COVID-19 Vaccination. 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: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Dizzy; Nausea; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced DIZZINESS (Dizzy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizzy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) 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. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication provided. No treatment information mentioned.  Patient experienced fatigue.  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: Asthenia, Bedridden, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: felt very weak; bedridden; felt like heck; Fever; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt very weak), BEDRIDDEN (bedridden), FEELING ABNORMAL (felt like heck), PYREXIA (Fever) and FATIGUE (exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt very weak), BEDRIDDEN (bedridden), FEELING ABNORMAL (felt like heck), PYREXIA (Fever) and FATIGUE (exhaustion). At the time of the report, ASTHENIA (felt very weak), BEDRIDDEN (bedridden), FEELING ABNORMAL (felt like heck), PYREXIA (Fever) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  The reporter said that a lady who got Moderna who said that she has the same thing happen to her. No further details provided about the lady who took Moderna.   Treatment medication 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.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Significant live follow up was added with new events.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Thrombosis
Clinical narrative: Clot blood; Lots of other conditions; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot blood) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 THROMBOSIS (Clot blood) (seriousness criterion medically significant) and IMMUNISATION REACTION (Lots of other conditions). At the time of the report, THROMBOSIS (Clot blood) and IMMUNISATION REACTION (Lots of other conditions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of thrombosis and an unexpected, non-serious event. The events occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient had a blood clot and 'lots of other conditions' (unspecified). No further details were provided. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of thrombosis and an unexpected, non-serious event. The events occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient had a blood clot and 'lots of other conditions' (unspecified). No further details were provided. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.