chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Myalgia, Nausea
Clinical narrative: Fevers, Tachycardia, Myalgias, Nausea, and Vomiting: requiring ED visit 2 L NS, 8 mg SL Zofran, Acetaminophen 500 mg,  and Toradol 15 mg.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, Tachycardia, Troponin, Urine analysis, Vomiting
Clinical narrative: Fevers, Tachycardia, Myalgias, Nausea, and Vomiting: requiring ED visit 2 L NS, 8 mg SL Zofran, Acetaminophen 500 mg,  and Toradol 15 mg.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abnormal sensation in eye, Facial pain, Headache, Injection site pain, Pain in jaw
Clinical narrative: Aching at injection site, 11:30pm beginning. Jaw and face pain- 3:00am day after Hot eyes- 3:00am day after Headache (top of skull)- 3:00am day after  Acetaminophen
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Chills, Feeling cold
Clinical narrative: Chills, can?t get warm, temp 95
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Inappropriate schedule of product administration
Clinical narrative: Abscess; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS (Abscess) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (1 in 2 wk), Solution for injection in pre-filled pen. On an unknown date, the patient experienced ABSCESS (Abscess) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with Surgery (Drainage of abscesses) for Abscess. At the time of the report, ABSCESS (Abscess) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication was reported.   The patient had to drain abscesses. Physician was testing to see if Humira was doing anything for her. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.  Company comment: This is a spontaneous case concerning a 21-year-old female patient with Crohn´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event abscess, on an unknown date after the second dose of mRNA-1273. Clinical findings, abscess location and diagnostic tests details were not provided. It was reported that the patient had to drain abscesses. Events seriousness captured as per IME list. Humira (Adalimumab) was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.  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.; Sender's Comments: Company comment: This is a spontaneous case concerning a 21-year-old female patient with Crohn´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event abscess, on an unknown date after the second dose of mRNA-1273. Clinical findings, abscess location and diagnostic tests details were not provided. It was reported that the patient had to drain abscesses. Events seriousness captured as per IME list. Humira (Adalimumab) was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for 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) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed the event as possibly related to Moderna vaccine and did not provide any causality assessment for the event with Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Hepatic failure
Clinical narrative: liver failure; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC FAILURE (liver failure) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC FAILURE (liver failure) (seriousness criterion medically significant). At the time of the report, HEPATIC FAILURE (liver failure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient was a healthy young women who went into liver failure after her second Moderna dose.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected serious (medically significant) AESI  of Hepatic failure that occurred in the context of mRNA-1273 vaccination(second dose). Latency cannot be assessed since vaccination date was not disclosed. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event and details pertaining to the previous dose was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected serious (medically significant) AESI  of Hepatic failure that occurred in the context of mRNA-1273 vaccination(second dose). Latency cannot be assessed since vaccination date was not disclosed. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event and details pertaining to the previous dose was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 50.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Joint swelling
Clinical narrative: JOINTS SWELL; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (JOINTS SWELL) and ARTHRALGIA (Joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and INFLUENZA VACCINE for Immunization.    No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2021, the patient experienced JOINT SWELLING (JOINTS SWELL) and ARTHRALGIA (Joint pain). The patient was treated with PREDNISONE at an unspecified dose and frequency. In 2021, JOINT SWELLING (JOINTS SWELL) and ARTHRALGIA (Joint pain) had resolved.            Concomitant medication was not reported.  The patient's joints started acting up after the immunizations (flu and COVID) for a few weeks. Patient had joint pain and her joints swelled so bad that she had to take Prednisone.  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: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anxiety, Blood test, Liver disorder, Vaccination site pain
Clinical narrative: Anxiety; sore arm; stage 4 liver disease; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (stage 4 liver disease), ANXIETY (Anxiety) and VACCINATION SITE PAIN (sore arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced LIVER DISORDER (stage 4 liver disease). On an unknown date, the patient experienced ANXIETY (Anxiety) and VACCINATION SITE PAIN (sore arm). The patient was treated with DULOXETINE for Anxiety, at a dose of 30 milligram twice a day. At the time of the report, LIVER DISORDER (stage 4 liver disease) outcome was unknown and ANXIETY (Anxiety) and VACCINATION SITE PAIN (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: stage 4 liver disease.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication was not reported.  He had nausea and vomiting after second dose, then it went away like four hours. 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.   This case was linked to MOD-2021-624828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Event verbatim and lower level term updated.
Sex: F
Vaccine: COVID19
Symptoms: Enzyme level test, Joint range of motion decreased, Pain in extremity
Clinical narrative: COULD NOT RAISE ARM; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (COULD NOT RAISE ARM) and PAIN IN EXTREMITY (SORE ARM) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced JOINT RANGE OF MOTION DECREASED (COULD NOT RAISE ARM) and PAIN IN EXTREMITY (SORE ARM). At the time of the report, JOINT RANGE OF MOTION DECREASED (COULD NOT RAISE ARM) and PAIN IN EXTREMITY (SORE ARM) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Enzyme level test: Enzyme level abnormal and Enzyme level resolved.         Concomitant medication was not reported.  On an unknown date, patient experienced enzymes level was abnormal. On an unknown date, enzymes level was resolved. Patient had sore arm and was not able to raise the arm. Treatment details were unknown.  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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: More aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (More aches and pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (More aches and pain). At the time of the report, PAIN (More aches and pain) was resolving.            No concomitant medications were reported. On an unknown date, the patient experienced more aches and pain. 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.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urticaria
Clinical narrative: Developed welt on abdomen / Was very itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed welt on abdomen / Was very itchy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (Developed welt on abdomen / Was very itchy). At the time of the report, URTICARIA (Developed welt on abdomen / Was very itchy) had not resolved.            No concomitant medication provided. No treatment information mentioned.  Patient developed welts on the abdomen and it was very itchy.  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: Headache, Pain, Vaccination site pain
Clinical narrative: COVID VACCINE CAUSED SORE ARM; HEADACHE; PAIN EVERY DAY; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (PAIN EVERY DAY), VACCINATION SITE PAIN (COVID VACCINE CAUSED SORE ARM) and HEADACHE (HEADACHE) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2019, the patient experienced PAIN (PAIN EVERY DAY). On an unknown date, the patient experienced VACCINATION SITE PAIN (COVID VACCINE CAUSED SORE ARM) and HEADACHE (HEADACHE). At the time of the report, PAIN (PAIN EVERY DAY) had not resolved and VACCINATION SITE PAIN (COVID VACCINE CAUSED SORE ARM) and HEADACHE (HEADACHE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment details were unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Ulcerative colitis.   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. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.            No concomitant medications were reported.  Patient received Humira (1153187).  No treatment medications were reported.  The reporter did not provide any causality assessment for the event with Humira and Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The patient got Moderna with no problem other than sore arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The patient got Moderna with no problem other than sore arms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (The patient got Moderna with no problem other than sore arms). At the time of the report, PAIN IN EXTREMITY (The patient got Moderna with no problem other than sore arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient got Moderna with no problem other than sore arms. No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Immunisation reaction, Joint stiffness, Pyrexia
Clinical narrative: stiffness in ankles; after each of covid-19 vaccine had reaction to vaccine; Diarrhea; tired; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (stiffness in ankles), IMMUNISATION REACTION (after each of covid-19 vaccine had reaction to vaccine), DIARRHOEA (Diarrhea), FATIGUE (tired) and PYREXIA (slight fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced JOINT STIFFNESS (stiffness in ankles), IMMUNISATION REACTION (after each of covid-19 vaccine had reaction to vaccine), DIARRHOEA (Diarrhea), FATIGUE (tired) and PYREXIA (slight fever). At the time of the report, JOINT STIFFNESS (stiffness in ankles) had not resolved and IMMUNISATION REACTION (after each of covid-19 vaccine had reaction to vaccine), DIARRHOEA (Diarrhea), FATIGUE (tired) and PYREXIA (slight fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Dysphonia
Clinical narrative: HOARSNESS OF VOICE; COUGH CAME BACK; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (HOARSNESS OF VOICE) and COUGH (COUGH CAME BACK) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In October 2021, the patient experienced COUGH (COUGH CAME BACK). On an unknown date, the patient experienced DYSPHONIA (HOARSNESS OF VOICE). At the time of the report, DYSPHONIA (HOARSNESS OF VOICE) and COUGH (COUGH CAME BACK) was resolving.            No relevant concomitant medications were reported.   The reporter's causality for the events of HOARSNESS OF VOICE and COUGH CAME BACK with HUMIRA(ADALIMUMAB) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Vaccination adverse reaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Ongoing. On an unknown date, the patient experienced DRUG INTERACTION (Vaccination adverse reaction). At the time of the report, DRUG INTERACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication use information was not provided by reporter.  On an unknown date, the patient experienced not saw best results from humira/humira was helping and felt it should be doing more.   It was unknown if patient was enrolled in a covid-19 vaccine trial.   Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE RESPONSE FOR A COUPLE OF DAYS.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (FLU LIKE RESPONSE FOR A COUPLE OF DAYS.) in a 67-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.    Concurrent medical conditions included Ankylosing spondylitis.   In September 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) Citrate Free. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (FLU LIKE RESPONSE FOR A COUPLE OF DAYS.). At the time of the report, INFLUENZA LIKE ILLNESS (FLU LIKE RESPONSE FOR A COUPLE OF DAYS.) outcome was unknown.            No relevant concomitant medications were reported.   The reporter's causality for the events of flu like response for a couple of days was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Lumbar spinal stenosis, Sleep disorder, Spondylitis, Vaccination site pain
Clinical narrative: spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis; sleeping was problem; spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis; had covid vaccine in left arm and it hurt; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), SPONDYLITIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis), SLEEP DISORDER (sleeping was problem), LUMBAR SPINAL STENOSIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis) and VACCINATION SITE PAIN (had covid vaccine in left arm and it hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 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) 1 dosage form. In December 2020, the patient experienced COVID-19 (COVID-19). In February 2021, the patient experienced VACCINATION SITE PAIN (had covid vaccine in left arm and it hurt). On an unknown date, the patient experienced SPONDYLITIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis), SLEEP DISORDER (sleeping was problem) and LUMBAR SPINAL STENOSIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis). At the time of the report, COVID-19 (COVID-19), SPONDYLITIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis), SLEEP DISORDER (sleeping was problem), LUMBAR SPINAL STENOSIS (spinal stenosis L 5 sitting the l1 on back and it giving lot of arthritis) and VACCINATION SITE PAIN (had covid vaccine in left arm and it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The causality for the Humira was reported as Not reported.   The treatment medication was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash pruritic
Clinical narrative: ITCHY RED RASH; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (ITCHY RED RASH) in a 60-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 June 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced RASH PRURITIC (ITCHY RED RASH). In 2021, RASH PRURITIC (ITCHY RED RASH) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache; Chills; Generalized aching; Fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), COVID-19 (COVID-19), PAIN (Generalized aching), PYREXIA (Fever) and HEADACHE (Headache) in a 52-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 31-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) Citrate Free. In December 2020, the patient experienced COVID-19 (COVID-19). On 31-Aug-2021, the patient experienced CHILLS (Chills), PAIN (Generalized aching) and PYREXIA (Fever). On 02-Sep-2021, the patient experienced HEADACHE (Headache). At the time of the report, CHILLS (Chills), COVID-19 (COVID-19) and HEADACHE (Headache) outcome was unknown and PAIN (Generalized aching) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine were reported. No known allergies were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the events of Chills, COVID-19, Headache was not provided and for the events of Generalized aching and Fever 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. No treatment medicine were reported.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: Productive cough; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Productive cough) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-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) 40 milligram every two months. In 2021, the patient experienced PRODUCTIVE COUGH (Productive cough). At the time of the report, PRODUCTIVE COUGH (Productive cough) was resolving.      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 unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive) 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 Ulcerative colitis.    The patient's past medical history included Ulcerative colitis.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-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) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19 virus test positive). At the time of the report, COVID-19 (COVID-19 virus test positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment-This spontaneous case concerns an elderly female patient aged 73 years with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (reported as COVID-19 virus test positive ) on unknown date (in 2021) in the context of mRNA-1273 vaccination.  Patient had received first and second dose of same vaccine at an interval of 28 days in 2021. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was resolving at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly female patient aged 73 years with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (reported as COVID-19 virus test positive ) on unknown date (in 2021) in the context of mRNA-1273 vaccination.  Patient had received first and second dose of same vaccine at an interval of 28 days in 2021. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was resolving at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Influenza like illness, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Flu like symptoms; Cold; Ear pain; Throat pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), NASOPHARYNGITIS (Cold), EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Throat pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 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) 1 dosage form. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), NASOPHARYNGITIS (Cold), EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Throat pain). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), NASOPHARYNGITIS (Cold), EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Throat pain) 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.  The reporter causality for the Humira for the events was reported as no reasonable possibility.  The treatment medication was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eye injury, Eye pain, Vaccination site pain, Wound infection
Clinical narrative: Unspecified laceration of eye; Sore eye; Wound infection; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), EYE INJURY (Unspecified laceration of eye), EYE PAIN (Sore eye) and WOUND INFECTION (Wound infection) 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 Rheumatoid arthritis.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced EYE INJURY (Unspecified laceration of eye), EYE PAIN (Sore eye) and WOUND INFECTION (Wound infection). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and EYE PAIN (Sore eye) had not resolved and EYE INJURY (Unspecified laceration of eye) and WOUND INFECTION (Wound infection) outcome was unknown.            No concomitant medicine were reported. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  For HUMIRA, the reporter causality for the events of Vaccination site pain, Eye injury, Eye pain and Wound infection was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were reported.   Reporter did not allow further contact
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: AFTER FIRST AND BOOSTER VACCINE DID NOT FEEL WELL; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (AFTER FIRST AND BOOSTER VACCINE DID NOT FEEL WELL) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (AFTER FIRST AND BOOSTER VACCINE DID NOT FEEL WELL). In 2021, IMMUNISATION REACTION (AFTER FIRST AND BOOSTER VACCINE DID NOT FEEL WELL) had resolved.            No relevant concomitant medications were reported.   The reporter's causality for the event of after first and booster vaccine did not feel well with skyrizi(risankizumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623129 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site erythema
Clinical narrative: COVID BOOSTER SHOT MADE ARM RED; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (COVID BOOSTER SHOT MADE ARM RED) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (COVID BOOSTER SHOT MADE ARM RED). At the time of the report, VACCINATION SITE ERYTHEMA (COVID BOOSTER SHOT MADE ARM RED) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: SECOND VACCINE KNOCKED PATIENT DOWN; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (SECOND VACCINE KNOCKED PATIENT DOWN) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate To Severe Chronic Plaque Psoriasis).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (SECOND VACCINE KNOCKED PATIENT DOWN). In 2021, IMMUNISATION REACTION (SECOND VACCINE KNOCKED PATIENT DOWN) had resolved.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the second vaccine knocked the patient down completely for a week.  The reporter's causality for the event of Vaccination adverse reaction was reported as no reasonable possibility for Skyrizi.  No treatment medication were 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.   This case was linked to MOD-2021-623127 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: ARM HURTS FROM COVID BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-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 2021, the patient experienced VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER). At the time of the report, VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER) was resolving.            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 information was provided   This case was linked to MOD-2021-624331 (Patient Link).