chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Malaise
Clinical narrative: has not been well since her booster/sick from the booster for a week/not able to leave the house, not even to walk the dog more than a short way; digestive issues kept her from leaving the house for 8 days; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (has not been well since her booster/sick from the booster for a week/not able to leave the house, not even to walk the dog more than a short way) and DYSPEPSIA (digestive issues kept her from leaving the house for 8 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect products included non-company products AGALSIDASE BETA for Fabry's disease and VENLAFAXINE HYDROCHLORIDE for Depression and Anxiety.    Concurrent medical conditions included Topical adhesive reaction, Dermatitis contact, Depression, Anxiety, Insomnia, Dizziness (She got dizzy and felt like she had to lie down or shoe would fall over), Pain (it was the pain that she had the last few infusions), Feeling abnormal, Pruritus, Fabry's disease, Panic attack, Nasopharyngitis and Eye disorder. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Premedication.   On 20-Oct-2015, the patient AGALSIDASE BETA (IV drip) dosage was changed to 100 milligram. On 01-Apr-2021, AGALSIDASE BETA (IV drip) dosage was changed to 100 milligram. On 08-Oct-2021, 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, AGALSIDASE BETA (IV drip) 100 milligram and VENLAFAXINE HYDROCHLORIDE (unknown route) at an unspecified dose. On 08-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (has not been well since her booster/sick from the booster for a week/not able to leave the house, not even to walk the dog more than a short way). In October 2021, the patient experienced DYSPEPSIA (digestive issues kept her from leaving the house for 8 days). At the time of the report, MALAISE (has not been well since her booster/sick from the booster for a week/not able to leave the house, not even to walk the dog more than a short way) outcome was unknown and DYSPEPSIA (digestive issues kept her from leaving the house for 8 days) had resolved.            No treatment medications were provided by the reporter  Patient said that she had not been well since her booster shot on Friday (malaise) 08-oct-2021, patient was sick from the booster for a week and digestive issues kept her from leaving the house for 8 days. She had not been able to leave the house, not even to walk the dog more than a short way.  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-2021-624460 (Patient Link).   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depressed mood, Fatigue, Insomnia, Somnolence
Clinical narrative: has not been well since her booster/sick from the booster for a week/not able to leave the house, not even to walk the dog more than a short way; digestive issues kept her from leaving the house for 8 days; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (has not been well since her booster/sick from the booster for a week/not able to leave the house, not even to walk the dog more than a short way) and DYSPEPSIA (digestive issues kept her from leaving the house for 8 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect products included non-company products AGALSIDASE BETA for Fabry's disease and VENLAFAXINE HYDROCHLORIDE for Depression and Anxiety.    Concurrent medical conditions included Topical adhesive reaction, Dermatitis contact, Depression, Anxiety, Insomnia, Dizziness (She got dizzy and felt like she had to lie down or shoe would fall over), Pain (it was the pain that she had the last few infusions), Feeling abnormal, Pruritus, Fabry's disease, Panic attack, Nasopharyngitis and Eye disorder. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Premedication.   On 20-Oct-2015, the patient AGALSIDASE BETA (IV drip) dosage was changed to 100 milligram. On 01-Apr-2021, AGALSIDASE BETA (IV drip) dosage was changed to 100 milligram. On 08-Oct-2021, 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, AGALSIDASE BETA (IV drip) 100 milligram and VENLAFAXINE HYDROCHLORIDE (unknown route) at an unspecified dose. On 08-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (has not been well since her booster/sick from the booster for a week/not able to leave the house, not even to walk the dog more than a short way). In October 2021, the patient experienced DYSPEPSIA (digestive issues kept her from leaving the house for 8 days). At the time of the report, MALAISE (has not been well since her booster/sick from the booster for a week/not able to leave the house, not even to walk the dog more than a short way) outcome was unknown and DYSPEPSIA (digestive issues kept her from leaving the house for 8 days) had resolved.            No treatment medications were provided by the reporter  Patient said that she had not been well since her booster shot on Friday (malaise) 08-oct-2021, patient was sick from the booster for a week and digestive issues kept her from leaving the house for 8 days. She had not been able to leave the house, not even to walk the dog more than a short way.  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-2021-624460 (Patient Link).   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Malaise
Clinical narrative: Sleepy; she had been feeling run down lately/ depression; trouble sleeping and could not sleep for more than 4 hours at a time; tired/been tired all the time/ super tired; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleepy), DEPRESSED MOOD (she had been feeling run down lately/ depression), INSOMNIA (trouble sleeping and could not sleep for more than 4 hours at a time) and FATIGUE (tired/been tired all the time/ super tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products AGALSIDASE BETA for Fabry's disease and VENLAFAXINE HYDROCHLORIDE for Depression and Anxiety.    Concurrent medical conditions included Dermatitis contact (Allergic reaction to adhesive) and Fabry's disease. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE for Nausea.   On 20-Oct-2015, the patient AGALSIDASE BETA (Intravenous) dosage was changed to 100 milligram. On 01-Apr-2021, AGALSIDASE BETA (Intravenous) dosage was changed to 100 milligram. In September 2021, AGALSIDASE BETA (Intravenous) dosage was changed to 100 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, AGALSIDASE BETA (Intravenous) 100 milligram and VENLAFAXINE HYDROCHLORIDE (unknown route) at an unspecified dose. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), DEPRESSED MOOD (she had been feeling run down lately/ depression), INSOMNIA (trouble sleeping and could not sleep for more than 4 hours at a time) and FATIGUE (tired/been tired all the time/ super tired). At the time of the report, SOMNOLENCE (Sleepy) outcome was unknown and DEPRESSED MOOD (she had been feeling run down lately/ depression), INSOMNIA (trouble sleeping and could not sleep for more than 4 hours at a time) and FATIGUE (tired/been tired all the time/ super tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Causality for Agalsidase beta was unassessable for pyrexia, cough and rhinorrhea, not related for pruritus, not reported for other events.  Causality for venlafaxine hydrochloride was related for headache, fatigue and not reported for other events.  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-2021-624452 (Patient Link).   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depressed mood, Fatigue, Insomnia, Somnolence
Clinical narrative: Sleepy; she had been feeling run down lately/ depression; trouble sleeping and could not sleep for more than 4 hours at a time; tired/been tired all the time/ super tired; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleepy), DEPRESSED MOOD (she had been feeling run down lately/ depression), INSOMNIA (trouble sleeping and could not sleep for more than 4 hours at a time) and FATIGUE (tired/been tired all the time/ super tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products AGALSIDASE BETA for Fabry's disease and VENLAFAXINE HYDROCHLORIDE for Depression and Anxiety.    Concurrent medical conditions included Dermatitis contact (Allergic reaction to adhesive) and Fabry's disease. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE for Nausea.   On 20-Oct-2015, the patient AGALSIDASE BETA (Intravenous) dosage was changed to 100 milligram. On 01-Apr-2021, AGALSIDASE BETA (Intravenous) dosage was changed to 100 milligram. In September 2021, AGALSIDASE BETA (Intravenous) dosage was changed to 100 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, AGALSIDASE BETA (Intravenous) 100 milligram and VENLAFAXINE HYDROCHLORIDE (unknown route) at an unspecified dose. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), DEPRESSED MOOD (she had been feeling run down lately/ depression), INSOMNIA (trouble sleeping and could not sleep for more than 4 hours at a time) and FATIGUE (tired/been tired all the time/ super tired). At the time of the report, SOMNOLENCE (Sleepy) outcome was unknown and DEPRESSED MOOD (she had been feeling run down lately/ depression), INSOMNIA (trouble sleeping and could not sleep for more than 4 hours at a time) and FATIGUE (tired/been tired all the time/ super tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Causality for Agalsidase beta was unassessable for pyrexia, cough and rhinorrhea, not related for pruritus, not reported for other events.  Causality for venlafaxine hydrochloride was related for headache, fatigue and not reported for other events.  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-2021-624452 (Patient Link).   Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Headache, Pyrexia, Tremor
Clinical narrative: COULD NOT STAND UP; Shaking; Fever; Headache; Chills; This spontaneous case was reported by a patient and describes the occurrence of DYSSTASIA (COULD NOT STAND UP), TREMOR (Shaking), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 34-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 Crohn's disease.    The patient's past medical history included Colonic fistula (FISTULA IN COLON/HAD SOME DRAINING, FISTULA IN COLON/HAD SOME DRAINING and SURGERY TO REMOVE THE COLON FISTULA DRAINAGE DUE TO THE INFECTION ON THE SITE.) on 01-Sep-2017 and Drain placement (FISTULA IN COLON/HAD SOME DRAINING, FISTULA IN COLON/HAD SOME DRAINING and SURGERY TO REMOVE THE COLON FISTULA DRAINAGE DUE TO THE INFECTION ON THE SITE.) on 28-Sep-2017. Concurrent medical conditions included Crohn's disease.   On 28-Nov-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg,1 in 1 wk,Citrate Free. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSSTASIA (COULD NOT STAND UP), TREMOR (Shaking), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). In 2021, DYSSTASIA (COULD NOT STAND UP), TREMOR (Shaking) and PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of CHILLS, FEVER onset in 2021, HEADACHE and FEVER onset in 2021 with HUMIRA was no reasonable possibility.  AbbVie's opinion is that there is no reasonable possibility that the events of CHILLS, COULD NOT STAND UP, FEVER onset in 2021, HEADACHE, SHAKING and FEVER onset in 2021 are related to HUMIRA.  Treatment details were not given.  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-2021-622087 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING GOOD; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (NOT FEELING GOOD) in a 64-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 Hidradenitis suppurativa.  No Medical History information was reported.   On 01-Aug-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 August 2021, the patient experienced MALAISE (NOT FEELING GOOD). In August 2021, MALAISE (NOT FEELING GOOD) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site swelling; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 73-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.  In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second 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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PRURITUS (Vaccination site pruritus). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had not resolved.  No concomitant medication information was reported. No treatment medication 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia, Unevaluable event, Urticaria
Clinical narrative: Hives; Diarrhea; Headache; Fever; Unevaluable event; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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. In 2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event). On an unknown date, the patient experienced URTICARIA (Hives) and DIARRHOEA (Diarrhea). At the time of the report, URTICARIA (Hives) had not resolved, DIARRHOEA (Diarrhea) outcome was unknown and HEADACHE (Headache), PYREXIA (Fever) and UNEVALUABLE EVENT (Unevaluable event) had resolved.            There was no reported medical history. Daily dose for HUMIRA was reported as Citrate Free. For HUMIRA, the reporter causality for the events of Hives, Diarrahea, Headache, Fever and Congestion was not provided. 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. No treatment medicine was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: A key stuck to her arm where she got Moderna; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (A key stuck to her arm where she got Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2021, 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 (A key stuck to her arm where she got Moderna). At the time of the report, IMMUNISATION REACTION (A key stuck to her arm where she got Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. It was reported that her ex-boyfriend called earlier to report and the patient did not have a reference number for previous report. A key stuck to her arm where she got the Moderna COVID shot. It stuck to arm where she had needle, and the other arm, it fell off. Ex-boyfriend got the Pfizer COVID vaccine and tried it and the key did not stick to his arm. She wanted to know why is the key sticking to her arm where she got the shot.  No treatment medication was reported. This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: He was still breast feeding and patient was fully Moderna vaccinated; No adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (He was still breast feeding and patient was fully Moderna vaccinated) and NO ADVERSE EVENT (No adverse 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (He was still breast feeding and patient was fully Moderna vaccinated) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (He was still breast feeding and patient was fully Moderna vaccinated) had resolved and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.            "He is still breast feeding and my wife is fully Moderna vaccinated. If it is at all of interest to see if he has the antibodies which some limited research has said is very likely, we'd be happy to discuss conducting a trial for that as well". No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A female patient of an unknown age reported to be fully vaccinated with mRNA-1273 vaccine and wanted to known If it was at all of interest to see if her son, who was still breast feeding, has the antibodies which some limited research has said is very likely. No adverse event was reported. Vaccination dates were not provided. 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. A female patient of an unknown age reported to be fully vaccinated with mRNA-1273 vaccine and wanted to known If it was at all of interest to see if her son, who was still breast feeding, has the antibodies which some limited research has said is very likely. No adverse event was reported. Vaccination dates were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 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 PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) 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 psoriatic arthritis.  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 reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that Patient experienced psoriatic arthritis and on an unknown date, patient also received RISANKIZUMAB (SKYRIZI) for moderate to severe chronic plaque Psoriasis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that Patient experienced psoriatic arthritis and on an unknown date, patient also received RISANKIZUMAB (SKYRIZI) for moderate to severe chronic plaque Psoriasis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cervical radiculopathy, Skin disorder
Clinical narrative: NERVE PAIN IN NECK INCREASED; SPOT ON BACK/RIB CAGE AND HIP; VERYSORE SHOULDER; This spontaneous case was reported by a consumer and describes the occurrence of CERVICAL RADICULOPATHY (NERVE PAIN IN NECK INCREASED), SKIN DISORDER (SPOT ON BACK/RIB CAGE AND HIP) and ARTHRALGIA (VERYSORE SHOULDER) 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.    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) Citrate Free. On an unknown date, the patient experienced CERVICAL RADICULOPATHY (NERVE PAIN IN NECK INCREASED), SKIN DISORDER (SPOT ON BACK/RIB CAGE AND HIP) and ARTHRALGIA (VERYSORE SHOULDER). At the time of the report, CERVICAL RADICULOPATHY (NERVE PAIN IN NECK INCREASED), SKIN DISORDER (SPOT ON BACK/RIB CAGE AND HIP) and ARTHRALGIA (VERYSORE SHOULDER) had resolved.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the events of SPOT ON BACK/RIB CAGE AND HIP, NERVE PAIN IN NECK INCREASED and VERY SORE SHOULDER was not provided. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pericarditis, Somnolence
Clinical narrative: Pericarditis; Somnolence; Pain; Tired out; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SOMNOLENCE (Somnolence), PAIN (Pain) and FATIGUE (Tired out). At the time of the report, PERICARDITIS (Pericarditis) had resolved and SOMNOLENCE (Somnolence), PAIN (Pain) and FATIGUE (Tired out) outcome was unknown.            No concomitant medications were reported.  On unknown dates, the patient experienced pericarditis and covid-19 injection which made to felt wore out and hurt and the patient slept for 24 hours.   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.   Company comment: This spontaneous case concerns a 67 year old male patient with concurrent condition of Plaque psoriasis, who experienced the expected, serious (medically significant) AESI of  Pericarditis, unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine, 1 month ago with no reported adverse events. No information on risk factors, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Co suspect adalimumab could be confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67 year old male patient with concurrent condition of Plaque psoriasis, who experienced the expected, serious (medically significant) AESI of  Pericarditis, unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine, 1 month ago with no reported adverse events. No information on risk factors, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Co suspect adalimumab could be confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fall, Gait disturbance, Muscle fatigue, Pyrexia
Clinical narrative: muscle weakness/muscle fatigue; just fallen while trying to beach the paddle board; shaky legs; walking has slowed; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (muscle weakness/muscle fatigue), FALL (just fallen while trying to beach the paddle board), TREMOR (shaky legs), GAIT DISTURBANCE (walking has slowed) and PYREXIA (fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ALGLUCOSIDASE ALFA (LUMIZYME) powder and solvent for concentrate for solution for infusion for Pompe's disease.    No Medical History information was reported.   On 12-Dec-2006, the patient started ALGLUCOSIDASE ALFA (LUMIZYME) (Intravenous) 1500 milligram once a week. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (muscle weakness/muscle fatigue), FALL (just fallen while trying to beach the paddle board), TREMOR (shaky legs), GAIT DISTURBANCE (walking has slowed), PYREXIA (fever) and CHILLS (chills). At the time of the report, MUSCLE FATIGUE (muscle weakness/muscle fatigue), FALL (just fallen while trying to beach the paddle board) and TREMOR (shaky legs) outcome was unknown and GAIT DISTURBANCE (walking has slowed), PYREXIA (fever) and CHILLS (chills) had resolved.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. It was reported that patient was being excited about the new drug as can see slow regression over time. Patient was discussed regression previously with HCP and states that Enzyme replacement therapy has probably flattened the progression of muscle weakness. Patient also talks about limitations and modifications were in order to paddle board. Patient reported that cannot push up and stand on knees and has to board from the shore in a standing position, backing up and sliding the feet gently as the stability of the board decreases as it moves from being grounded to floating. It was reported that patient also talks about having just fallen while trying to beach the paddle board. Patient talks about the muscle fatigue and shaky legs after paddle boarding for a while and the need to be extremely careful while stepping off the board onto the shore. No treatment medications were reported.   This case was linked to MOD-2021-624488 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: muscle weakness/muscle fatigue; just fallen while trying to beach the paddle board; shaky legs; walking has slowed; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (muscle weakness/muscle fatigue), FALL (just fallen while trying to beach the paddle board), TREMOR (shaky legs), GAIT DISTURBANCE (walking has slowed) and PYREXIA (fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ALGLUCOSIDASE ALFA (LUMIZYME) powder and solvent for concentrate for solution for infusion for Pompe's disease.    No Medical History information was reported.   On 12-Dec-2006, the patient started ALGLUCOSIDASE ALFA (LUMIZYME) (Intravenous) 1500 milligram once a week. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (muscle weakness/muscle fatigue), FALL (just fallen while trying to beach the paddle board), TREMOR (shaky legs), GAIT DISTURBANCE (walking has slowed), PYREXIA (fever) and CHILLS (chills). At the time of the report, MUSCLE FATIGUE (muscle weakness/muscle fatigue), FALL (just fallen while trying to beach the paddle board) and TREMOR (shaky legs) outcome was unknown and GAIT DISTURBANCE (walking has slowed), PYREXIA (fever) and CHILLS (chills) had resolved.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. It was reported that patient was being excited about the new drug as can see slow regression over time. Patient was discussed regression previously with HCP and states that Enzyme replacement therapy has probably flattened the progression of muscle weakness. Patient also talks about limitations and modifications were in order to paddle board. Patient reported that cannot push up and stand on knees and has to board from the shore in a standing position, backing up and sliding the feet gently as the stability of the board decreases as it moves from being grounded to floating. It was reported that patient also talks about having just fallen while trying to beach the paddle board. Patient talks about the muscle fatigue and shaky legs after paddle boarding for a while and the need to be extremely careful while stepping off the board onto the shore. No treatment medications were reported.   This case was linked to MOD-2021-624488 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medication 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: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pyrexia, Sinusitis
Clinical narrative: Fatigue extreme; Fever; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), FATIGUE (Fatigue extreme) and PYREXIA (Fever) 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 RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-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 startedRINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue extreme) and PYREXIA (Fever). On an unknown date, the patient experienced SINUSITIS (Sinus infection). In September 2021, FATIGUE (Fatigue extreme) and PYREXIA (Fever) had resolved. At the time of the report, SINUSITIS (Sinus infection) had resolved.            No concomitant medication was reported.   Patient had sinus infection for two weeks. On 30 Aug 2021, she had a covid booster shot. She stated that she ran a mild fever and felt very fatigued for about a day after. It was unknown if patient was enrolled in a covid-19 vaccine trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Osteoarthritis, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Osteoarthritis; CARPAL TUNNEL; AFTER LAST BOOSTER SHOT ARM GOT HOT; AFTER LAST BOOSTER SHOT ARM WAS ITCHING; AFTER LAST BOOSTER SHOT ARM WAS SORE; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL), VACCINATION SITE WARMTH (AFTER LAST BOOSTER SHOT ARM GOT HOT), VACCINATION SITE PRURITUS (AFTER LAST BOOSTER SHOT ARM WAS ITCHING) and VACCINATION SITE PAIN (AFTER LAST BOOSTER SHOT ARM WAS SORE) 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 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 OSTEOARTHRITIS (Osteoarthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL), VACCINATION SITE WARMTH (AFTER LAST BOOSTER SHOT ARM GOT HOT), VACCINATION SITE PRURITUS (AFTER LAST BOOSTER SHOT ARM WAS ITCHING) and VACCINATION SITE PAIN (AFTER LAST BOOSTER SHOT ARM WAS SORE). At the time of the report, OSTEOARTHRITIS (Osteoarthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL), VACCINATION SITE WARMTH (AFTER LAST BOOSTER SHOT ARM GOT HOT), VACCINATION SITE PRURITUS (AFTER LAST BOOSTER SHOT ARM WAS ITCHING) and VACCINATION SITE PAIN (AFTER LAST BOOSTER SHOT ARM WAS SORE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Concomitant medication and treatment information was not provided.  The reporter's causality for the event of osteoarthritis 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Depression, Nasal congestion, Productive cough
Clinical narrative: He was feeling depressed; Productive cough; having chills off; Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), DEPRESSION (He was feeling depressed), PRODUCTIVE COUGH (Productive cough) and CHILLS (having chills off) in a 64-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.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE ).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In November 2021, the patient experienced NASAL CONGESTION (Nasal congestion), PRODUCTIVE COUGH (Productive cough) and CHILLS (having chills off). On an unknown date, the patient experienced DEPRESSION (He was feeling depressed). At the time of the report, NASAL CONGESTION (Nasal congestion) was resolving, DEPRESSION (He was feeling depressed) had not resolved and PRODUCTIVE COUGH (Productive cough) and CHILLS (having chills off) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment medications were provided.  It was reported that patient was having chills off and on but never checked to see if he had a fever. He was feeling depressed but denied any thought of harming or suicide himself.  The reporter's causality for the evens of nasal congestion, depression, chills and productive cough with Rinvoq(upadacitinib) 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: F
Vaccine: COVID19
Symptoms: Dyspepsia, Fatigue, Feeding disorder, Headache, Insomnia
Clinical narrative: Stiffness; Indigestion; HARD TIME SLEEPING; Pain; COULD NOT EAT FOR A DAY AND HALF; Headache; Tiredness; BOOSTER MODERNA VACCINE CAUSES SORENESS AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), DYSPEPSIA (Indigestion), INSOMNIA (HARD TIME SLEEPING), PAIN (Pain) and FEEDING DISORDER (COULD NOT EAT FOR A DAY AND HALF) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    Concurrent medical conditions included Panuveitis (non-infectious intermediate, posterior and panuveitis).   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. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), DYSPEPSIA (Indigestion), INSOMNIA (HARD TIME SLEEPING), PAIN (Pain), FEEDING DISORDER (COULD NOT EAT FOR A DAY AND HALF), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (BOOSTER MODERNA VACCINE CAUSES SORENESS AT INJECTION SITE). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), DYSPEPSIA (Indigestion), INSOMNIA (HARD TIME SLEEPING), PAIN (Pain), FEEDING DISORDER (COULD NOT EAT FOR A DAY AND HALF), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (BOOSTER MODERNA VACCINE CAUSES SORENESS AT INJECTION SITE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication and treatment information was provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Vaccination site pain
Clinical narrative: Stiffness; Indigestion; HARD TIME SLEEPING; Pain; COULD NOT EAT FOR A DAY AND HALF; Headache; Tiredness; BOOSTER MODERNA VACCINE CAUSES SORENESS AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), DYSPEPSIA (Indigestion), INSOMNIA (HARD TIME SLEEPING), PAIN (Pain) and FEEDING DISORDER (COULD NOT EAT FOR A DAY AND HALF) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    Concurrent medical conditions included Panuveitis (non-infectious intermediate, posterior and panuveitis).   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. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), DYSPEPSIA (Indigestion), INSOMNIA (HARD TIME SLEEPING), PAIN (Pain), FEEDING DISORDER (COULD NOT EAT FOR A DAY AND HALF), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (BOOSTER MODERNA VACCINE CAUSES SORENESS AT INJECTION SITE). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), DYSPEPSIA (Indigestion), INSOMNIA (HARD TIME SLEEPING), PAIN (Pain), FEEDING DISORDER (COULD NOT EAT FOR A DAY AND HALF), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (BOOSTER MODERNA VACCINE CAUSES SORENESS AT INJECTION SITE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication and treatment information was provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in