chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, COVID-19, Influenza like illness, Myalgia, Spondylitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Hand arthritis), SPONDYLITIS (Back arthritis), COVID-19 (COVID-19), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle soreness) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (Hand arthritis), SPONDYLITIS (Back arthritis), COVID-19 (COVID-19), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle soreness). At the time of the report, ARTHRITIS (Hand arthritis) and SPONDYLITIS (Back arthritis) had not resolved and COVID-19 (COVID-19), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle soreness) had resolved. No concomitant medication information provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication information provided. Company Comment: This is a spontaneous case concerning a 48-year-old patient of unknown gender with medical history of Rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Arthritis, Spondylitis and COVID-19, on unknown date after receiving 3 doses of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the events, clinical course, relevant diagnostic tests and further treatment details were not provided in the case. At the time of the report, the events Arthritis and Spondylitis had not resolved while the event COVID-19 had resolved. Medical history of Rheumatoid arthritis remains a risk factor for the events Arthritis and Spondylitis. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 48-year-old patient of unknown gender with medical history of Rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Arthritis, Spondylitis and COVID-19, on unknown date after receiving 3 doses of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the events, clinical course, relevant diagnostic tests and further treatment details were not provided in the case. At the time of the report, the events Arthritis and Spondylitis had not resolved while the event COVID-19 had resolved. Medical history of Rheumatoid arthritis remains a risk factor for the events Arthritis and Spondylitis. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Furuncle
Clinical narrative: Boils on but and in between legs; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Boils on but and in between legs) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2022, the patient experienced FURUNCLE (Boils on but and in between legs). At the time of the report, FURUNCLE (Boils on but and in between legs) was resolving. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. On an unknown date, the patient had Humira, and it was not working (drug ineffective). The reporter causality of the Humira for the boil and drug ineffective were not reported. It was unknown if the patient was enrolled in a COVID-19 vaccine Trial. Humira formulation reported Solution for injection in pre-filled pen No treatment medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hair growth abnormal, Inappropriate schedule of product administration
Clinical narrative: Hair growth abnormal; Fatigue; one dose adminstered on 09-SEP-2021 and another on 20-SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of HAIR GROWTH ABNORMAL (Hair growth abnormal), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (one dose adminstered on 09-SEP-2021 and another on 20-SEP-2021) in a 21-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 an unknown indication.    No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2022, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (one dose adminstered on 09-SEP-2021 and another on 20-SEP-2021). In 2022, the patient experienced HAIR GROWTH ABNORMAL (Hair growth abnormal) and FATIGUE (Fatigue). At the time of the report, HAIR GROWTH ABNORMAL (Hair growth abnormal) and FATIGUE (Fatigue) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (one dose adminstered on 09-SEP-2021 and another on 20-SEP-2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Headache, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: Headache; Allergy; Exposure to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergy), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis.    The patient's past medical history included Exposure to COVID-19.   On 18-Jul-2022, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In July 2022, the patient experienced HYPERSENSITIVITY (Allergy) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). On 18-Jul-2022, the patient experienced HEADACHE (Headache). At the time of the report, HYPERSENSITIVITY (Allergy), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that there was not have the lot number information, because the packaging was discarded. No treatment medications were reported.
Age: 17.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cardiac disorder, Injury, Palpitations, Psoriasis
Clinical narrative: Heart disorder/Heart Issue; Palpitations/HEART PALPITATIONS; Plaque psoriasis bad flare up that was triggered from injury; Injury; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart disorder/Heart Issue), PALPITATIONS (Palpitations/HEART PALPITATIONS), PSORIASIS (Plaque psoriasis bad flare up that was triggered from injury) and INJURY (Injury) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Patient was diagnosed with plaque psoriasis at about 10 years old.) since 2010.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) 1 dosage form. In 2018, the patient experienced PSORIASIS (Plaque psoriasis bad flare up that was triggered from injury) and INJURY (Injury). On 31-Oct-2021, the patient experienced PALPITATIONS (Palpitations/HEART PALPITATIONS). On an unknown date, the patient experienced CARDIAC DISORDER (Heart disorder/Heart Issue). At the time of the report, CARDIAC DISORDER (Heart disorder/Heart Issue), PSORIASIS (Plaque psoriasis bad flare up that was triggered from injury) and INJURY (Injury) outcome was unknown and PALPITATIONS (Palpitations/HEART PALPITATIONS) had not resolved.            Concomitant medication was not provided. Patient still gets palpitations about every other night on an average. He tried several things for plaque psoriasis. Treatment information was not reported. For drug Skyrizi, the reporter causality was given as not reported for Palpitations and Mfr. causality reported as No reasonable possibility for Palpitations. It was unknown if patient was enrolled in a covid-19 vaccine Trial.
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: COVID-19, Mental disorder
Clinical narrative: COVID-19; Mental disorder/Mental issue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and MENTAL DISORDER (Mental disorder/Mental issue) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and USTEKINUMAB (STELARA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and USTEKINUMAB (STELARA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and MENTAL DISORDER (Mental disorder/Mental issue). At the time of the report, COVID-19 (COVID-19) and MENTAL DISORDER (Mental disorder/Mental issue) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.  Company Comment:  This is a spontaneous case concerning an adult male patient of unspecified age with concomitant medication of Adalimumab and Ustekinumab as co-suspect drugs, who experienced the unexpected non-serious  adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. The patient also experienced mental disorder described as mental issues. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The co-suspect drugs Adalimumab and Ustekinumab, which are immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult male patient of unspecified age with concomitant medication of Adalimumab and Ustekinumab as co-suspect drugs, who experienced the unexpected non-serious  adverse event of special interest COVID-19, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. The patient also experienced mental disorder described as mental issues. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The co-suspect drugs Adalimumab and Ustekinumab, which are immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: Drug interaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Drug interaction) in a 41-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 an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DRUG INTERACTION (Drug interaction). At the time of the report, DRUG INTERACTION (Drug interaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Reported that on an unknown date, the patient experienced Humira did not work well by itself. Moderna covid-19 vaccine (Elasomeran) was also considered suspect. Reported Causality for Drug ineffective (Humira did not work well by itself) for Moderna COVID-19 vaccine reported as Possible. It was unknown whether patient was enrolled in a COVID-19 vaccine trial. No treatment medication was reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse food reaction, Decreased appetite, Headache, Inflammation
Clinical narrative: Adverse food reaction; Appetite lost; Inflammation; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE FOOD REACTION (Adverse food reaction), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation) and HEADACHE (headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE FOOD REACTION (Adverse food reaction), DECREASED APPETITE (Appetite lost), INFLAMMATION (Inflammation) and HEADACHE (headache). At the time of the report, ADVERSE FOOD REACTION (Adverse food reaction) and INFLAMMATION (Inflammation) was resolving and DECREASED APPETITE (Appetite lost) and HEADACHE (headache) had resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. The reporter's causality for the event(s) of INCREASE IN INFLAMMATION POSSIBLY DUE TO DIET unknown onset, LOSS OF APPETITE, INCREASE IN INFLAMMATION POSSIBLY DUE TO DIET unknown onset and HEADACHES with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Ache; Tiredness; Fever/LOW GRADE FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), FATIGUE (Tiredness) and PYREXIA (Fever/LOW GRADE FEVER) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, 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 PAIN (Ache), FATIGUE (Tiredness) and PYREXIA (Fever/LOW GRADE FEVER). At the time of the report, PAIN (Ache), FATIGUE (Tiredness) and PYREXIA (Fever/LOW GRADE FEVER) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 24.83 out of 25, Very high.         No concomitant medication information provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Immunisation reaction, Nasopharyngitis, Vomiting
Clinical narrative: Cold; Vomiting; Reaction to covid-19 vaccine / Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Reaction to covid-19 vaccine / Vaccination adverse reaction), NASOPHARYNGITIS (Cold) and VOMITING (Vomiting) 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 Crohn's disease.    No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-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) at an unspecified dose. On 31-Aug-2021, the patient experienced IMMUNISATION REACTION (Reaction to covid-19 vaccine / Vaccination adverse reaction). On 09-Apr-2022, the patient experienced VOMITING (Vomiting). In June 2022, the patient experienced NASOPHARYNGITIS (Cold). In June 2022, NASOPHARYNGITIS (Cold) had resolved. At the time of the report, IMMUNISATION REACTION (Reaction to covid-19 vaccine / Vaccination adverse reaction) had resolved and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: High.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were provided by the reporter. Patient had taken Humira drug in the form of Solution for injection in pre filled pen. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I got the adverse effect, getting from Moderna went to the hospital; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I got the adverse effect, getting from Moderna went to the hospital) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 029L208A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I got the adverse effect, getting from Moderna went to the hospital) (seriousness criterion hospitalization). At the time of the report, IMMUNISATION REACTION (I got the adverse effect, getting from Moderna went to the hospital) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Consumer stated that, got the adverse effect from  the Moderna vaccine.   Company Comment:  This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the unexpected serious (hospitalization) event of Immunisation reaction, reported as adverse effect after Moderna vaccination, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient had unspecified side effect from Moderna COVID-19 vaccine, which prompted the patient to go to emergency department. However, it was not mentioned if the patient was admitted in the hospital for more than 24 hours. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the unexpected serious (hospitalization) event of Immunisation reaction, reported as adverse effect after Moderna vaccination, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. It was reported that the patient had unspecified side effect from Moderna COVID-19 vaccine, which prompted the patient to go to emergency department. However, it was not mentioned if the patient was admitted in the hospital for more than 24 hours. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness
Clinical narrative: INCREASED STIFFNESS AFTER COVID VACCINE. MODERNA COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (INCREASED STIFFNESS AFTER COVID VACCINE. MODERNA COVID-19 VACCINE) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (INCREASED STIFFNESS AFTER COVID VACCINE. MODERNA COVID-19 VACCINE). At the time of the report, MUSCULOSKELETAL STIFFNESS (INCREASED STIFFNESS AFTER COVID VACCINE. MODERNA COVID-19 VACCINE) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Vaccination site bruising; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising) in a 54-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.   In July 2022, 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In July 2022, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising). In July 2022, VACCINATION SITE BRUISING (Vaccination site bruising) had resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Device issue, Injection site pain
Clinical narrative: Device issue; Injection site burning; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE ISSUE (Device issue) and INJECTION SITE PAIN (Injection site burning) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Drug allergy.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 22-Jul-2022, the patient experienced DEVICE ISSUE (Device issue) and INJECTION SITE PAIN (Injection site burning). On 22-Jul-2022, DEVICE ISSUE (Device issue) and INJECTION SITE PAIN (Injection site burning) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  No concomitant drugs taken by the patient.  Moderna vaccine was taken 1 in once for all doses.  It was reported that patient had burned skin when humira pen misfire.  No treatment information was provided.   This case was linked to MOD-2022-617503 (Patient Link).   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Rhinorrhoea
Clinical narrative: Sniffles and stuff like that ( not further clarified); She was going to get fourth dose but wasn't able to receive it; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Sniffles and stuff like that ( not further clarified)) and PRODUCT ADMINISTRATION INTERRUPTED (She was going to get fourth dose but wasn't able to receive it) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included C-section. Concurrent medical conditions included Asthma, Multiple sclerosis, Allergy to antibiotic (Bactrim DS), Drug allergy (Cipro), Drug allergy (Sulfa), Drug allergy (Epinephrine), Drug allergy (Naproxen), Drug allergy (Tramadol), Pain, Fatigue and Numbness. Concomitant products included OCRELIZUMAB (OCREVUS), DULOXETINE, OXCARBAZEPINE, BACLOFEN, MODAFINIL, GABAPENTIN, FLECAINIDE and TOPIRAMATE for an unknown indication.   In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced RHINORRHOEA (Sniffles and stuff like that ( not further clarified)) and PRODUCT ADMINISTRATION INTERRUPTED (She was going to get fourth dose but wasn't able to receive it). At the time of the report, RHINORRHOEA (Sniffles and stuff like that ( not further clarified)) and PRODUCT ADMINISTRATION INTERRUPTED (She was going to get fourth dose but wasn't able to receive it) outcome was unknown.            In 2022, the Patient started therapy with Moderna COVID-19 Vaccine for COVID and patient stated that patient was going to get the fourth dose. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2022: Live Follow up received contained patient middle name were added.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose -20-MAR-2021and 2nd dose-02-APR-2022; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -20-MAR-2021and 2nd dose-02-APR-2022) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -20-MAR-2021and 2nd dose-02-APR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -20-MAR-2021and 2nd dose-02-APR-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided          No concomitant medication were reported. No treatment information were provided.   This case was linked to MOD-2022-617420 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Joint swelling
Clinical narrative: Swollen joint; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen joint) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (Swollen joint) and FATIGUE (Fatigue). At the time of the report, JOINT SWELLING (Swollen joint) was resolving and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Patient had reported that swollen joints in hands and knees. Patient was extremely fatigue after a covid. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Frustration tolerance decreased, Psoriasis
Clinical narrative: Psoriasis aggravated; Frustration; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis aggravated) and FRUSTRATION TOLERANCE DECREASED (Frustration) in a 38-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In March 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis aggravated) and FRUSTRATION TOLERANCE DECREASED (Frustration). At the time of the report, PSORIASIS (Psoriasis aggravated) had not resolved and FRUSTRATION TOLERANCE DECREASED (Frustration) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant Drugs Not Reported. Patient psoriasis was worsened since she was late on her shot. They were frustrated. She had a bad reaction to the Moderna COVID vaccine and broke out in psoriasis. She had been on Skyrizi for years and it worked for the psoriasis but without it, she had patches of psoriasis come up. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event(s) of FRUSTRATED and PSORIASIS WORSENING/PSORIASIS PATCHES/BROKE OUT IN PSORIASIS AFTER MODERNA COVID VACCINE was not provided. No treatment were reported.
Age: 45.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Intraocular pressure increased
Clinical narrative: Elevated eye pressure; FELT WEIRD; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (FELT WEIRD) and INTRAOCULAR PRESSURE INCREASED (Elevated eye pressure) in a 45-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 Panuveitis.    Concurrent medical conditions included Panuveitis.   In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. In December 2021, the patient experienced FEELING ABNORMAL (FELT WEIRD). On an unknown date, the patient experienced INTRAOCULAR PRESSURE INCREASED (Elevated eye pressure). At the time of the report, FEELING ABNORMAL (FELT WEIRD) had resolved and INTRAOCULAR PRESSURE INCREASED (Elevated eye pressure) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No Concomitant medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No Treatment medication reported.
Age: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Device issue, Injection site pain
Clinical narrative: Device issue / appears not to released needle; Strong burning sensation / pain during injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Strong burning sensation / pain during injection) and DEVICE ISSUE (Device issue / appears not to released needle) in a 78-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 Plaque psoriasis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (40 mg,1 in 2 wk). On 01-Apr-2022, the patient experienced INJECTION SITE PAIN (Strong burning sensation / pain during injection). On an unknown date, the patient experienced DEVICE ISSUE (Device issue / appears not to released needle). In 2022, INJECTION SITE PAIN (Strong burning sensation / pain during injection) had resolved. At the time of the report, DEVICE ISSUE (Device issue / appears not to released needle) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient had taken the Humira drug in the form of Solution for injection in pre filled pen. No treatment information was provided.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Ulcer
Clinical narrative: painful focal labial ulcerations 2 days after the Covid booster was provided; Revaccination with different COVID-19 vaccine; interchange of vaccine products; This spontaneous case was reported by a physician and describes the occurrence of ULCER (painful focal labial ulcerations 2 days after the Covid booster was provided), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Comirnaty (Dose 2) and Comirnaty (Dose 1). Past adverse reactions to the above products included No adverse event with Comirnaty and Comirnaty.    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 ULCER (painful focal labial ulcerations 2 days after the Covid booster was provided), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, ULCER (painful focal labial ulcerations 2 days after the Covid booster was provided), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness/very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness/very tired) 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 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 FATIGUE (Tiredness/very tired). At the time of the report, FATIGUE (Tiredness/very tired) 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.  Patient got co-suspect Humira in solution for injection in pre-filled pen.  No concomitant medication was reported by reporter.  Patient got Moderna booster on an unknown date.  The reporter causality for the event with respect to Humira was reasonable possibility.  No treatment medication was reported by reporter.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Injection site nodule, Wrong technique in product usage process
Clinical narrative: Injection site nodule; Wrong injection technique; First dose on 1-jan-2021 and second dose on 1-apr-2021; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (Injection site nodule), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wrong injection technique) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-jan-2021 and second dose on 1-apr-2021) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Jan-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE NODULE (Injection site nodule), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wrong injection technique) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-jan-2021 and second dose on 1-apr-2021). At the time of the report, INJECTION SITE NODULE (Injection site nodule), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Wrong injection technique) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 1-jan-2021 and second dose on 1-apr-2021) outcome was unknown.            There was no reported medical history. The patient took skyrizi shot and it was stuck in leg but able to get medication, this went too far of an angle and pulling at the skin. No concomitant medication were reported. No treatment information were provided. The reporter's causality for the events of SKYRIZI PEN stuck in pen with needle odd angle and developed a knot after SKYRIZI SHOT was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dizziness, Immunisation reaction, Skin fissures
Clinical narrative: Seems like it gave COVID; Fissures of skin/cracking of skin on fingers near cuticles; Little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Seems like it gave COVID), SKIN FISSURES (Fissures of skin/cracking of skin on fingers near cuticles) and DIZZINESS (Little dizzy) in a 60-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 an unknown indication.    Concomitant products included COVID-19 VACCINE for COVID-19 vaccination.   In June 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. In 2022, the patient experienced SKIN FISSURES (Fissures of skin/cracking of skin on fingers near cuticles) and DIZZINESS (Little dizzy). In June 2022, the patient experienced IMMUNISATION REACTION (Seems like it gave COVID). At the time of the report, IMMUNISATION REACTION (Seems like it gave COVID), SKIN FISSURES (Fissures of skin/cracking of skin on fingers near cuticles) and DIZZINESS (Little dizzy) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No known allergies were reported.  The reporter's causality for the event(s) of received Imbruvica, it seems like it gave COVID, little dizzy and cracking of skin on fingers near cuticles was not reported.  No treatment details were provided
Age: 46.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Crohn's disease, Gastrointestinal inflammation, Nausea, Pain
Clinical narrative: Groggy; Energy decreased/Low energy; Intestinal inflammation/Inflammation in intestines; Ache/Achy; Nausea; Crohn's aggravated/Crohn's flare ups; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's aggravated/Crohn's flare ups), SOMNOLENCE (Groggy), ASTHENIA (Energy decreased/Low energy), GASTROINTESTINAL INFLAMMATION (Intestinal inflammation/Inflammation in intestines) and PAIN (Ache/Achy) in a 46-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 (HUMIRA) for Crohn's disease.    Patient had no known allergies and no other relevant medical history.  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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In July 2022, the patient experienced CROHN'S DISEASE (Crohn's aggravated/Crohn's flare ups). On an unknown date, the patient experienced SOMNOLENCE (Groggy), ASTHENIA (Energy decreased/Low energy), GASTROINTESTINAL INFLAMMATION (Intestinal inflammation/Inflammation in intestines), PAIN (Ache/Achy) and NAUSEA (Nausea). At the time of the report, CROHN'S DISEASE (Crohn's aggravated/Crohn's flare ups) had not resolved and SOMNOLENCE (Groggy), ASTHENIA (Energy decreased/Low energy), GASTROINTESTINAL INFLAMMATION (Intestinal inflammation/Inflammation in intestines), PAIN (Ache/Achy) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported.  On an unknown date, patient underwent colonoscopy and results were not provided.  No treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Causality for Humira The reporter's causality for the event(s) of Crohn's flare ups, groggy, low energy, inflammation in intestines, achy and nausea was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Somnolence
Clinical narrative: Groggy; Energy decreased/Low energy; Intestinal inflammation/Inflammation in intestines; Ache/Achy; Nausea; Crohn's aggravated/Crohn's flare ups; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's aggravated/Crohn's flare ups), SOMNOLENCE (Groggy), ASTHENIA (Energy decreased/Low energy), GASTROINTESTINAL INFLAMMATION (Intestinal inflammation/Inflammation in intestines) and PAIN (Ache/Achy) in a 46-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 (HUMIRA) for Crohn's disease.    Patient had no known allergies and no other relevant medical history.  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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In July 2022, the patient experienced CROHN'S DISEASE (Crohn's aggravated/Crohn's flare ups). On an unknown date, the patient experienced SOMNOLENCE (Groggy), ASTHENIA (Energy decreased/Low energy), GASTROINTESTINAL INFLAMMATION (Intestinal inflammation/Inflammation in intestines), PAIN (Ache/Achy) and NAUSEA (Nausea). At the time of the report, CROHN'S DISEASE (Crohn's aggravated/Crohn's flare ups) had not resolved and SOMNOLENCE (Groggy), ASTHENIA (Energy decreased/Low energy), GASTROINTESTINAL INFLAMMATION (Intestinal inflammation/Inflammation in intestines), PAIN (Ache/Achy) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported.  On an unknown date, patient underwent colonoscopy and results were not provided.  No treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Causality for Humira The reporter's causality for the event(s) of Crohn's flare ups, groggy, low energy, inflammation in intestines, achy and nausea was not provided.