chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: External ear pain, Limb discomfort, Nasopharyngitis, Paraesthesia
Clinical narrative: Cold; External ear pain; Facial paresthesia; Arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), EXTERNAL EAR PAIN (External ear pain), PARAESTHESIA (Facial paresthesia) and LIMB DISCOMFORT (Arm discomfort) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-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). In November 2021, the patient experienced EXTERNAL EAR PAIN (External ear pain), PARAESTHESIA (Facial paresthesia) and LIMB DISCOMFORT (Arm discomfort). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) had not resolved and EXTERNAL EAR PAIN (External ear pain), PARAESTHESIA (Facial paresthesia) and LIMB DISCOMFORT (Arm discomfort) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. There was no reported medical history.  No treatment and concomitant medication provided.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: Feeling unwell; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Feeling unwell) 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 Ulcerative colitis.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) had resolved.            No concomitant medication information was provided. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Laryngitis, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; LOW FEVER; Laryngitis; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGITIS (Laryngitis), PAIN IN EXTREMITY (SORE ARM) and PYREXIA (LOW FEVER) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 12-Nov-2021, the patient experienced LARYNGITIS (Laryngitis). On an unknown date, the patient experienced PAIN IN EXTREMITY (SORE ARM) and PYREXIA (LOW FEVER). At the time of the report, LARYNGITIS (Laryngitis), PAIN IN EXTREMITY (SORE ARM) and PYREXIA (LOW FEVER) outcome was unknown.            No concomitant products were reported.  On unknown dates, the patient experienced sore arm and low fever. On 12/Nov/2021, the patient experienced laryngitis. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On Feb-2021, patient received 1st dose covid-19 vaccine manufactured by moderna, lot number unknown, expiration date unknown. On Mar 2021, patient received 2nd dose covid-19 vaccine manufactured by moderna, lot number unknown, expiration date unknown. On unknown date, patient received booster dose covid-19 vaccine manufactured by moderna, lot number unknown, expiration date unknown.  Causality for humira (adalimumab) The reporter's causality for the event(s) of laryngitis, sore arm and low fever was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Unevaluable event
Clinical narrative: Unevaluable event; PATIENT WAS IN BED FOR 18 HRS and NOT FEELING WELL; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) and MALAISE (PATIENT WAS IN BED FOR 18 HRS and NOT FEELING WELL) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event) and MALAISE (PATIENT WAS IN BED FOR 18 HRS and NOT FEELING WELL). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) and MALAISE (PATIENT WAS IN BED FOR 18 HRS and NOT FEELING WELL) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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. The patient was in bed for 18 hrs after taken the second COVID vaccination shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.
Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: Injection site pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a non-health professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INJECTION SITE PAIN (Injection site pain) in a 30-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 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 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) Solution for injection in pre-filled pen. On 15-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and INJECTION SITE PAIN (Injection site pain) had resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Skin disorder
Clinical narrative: Skin disorder/ Spots on middle of back; had really high fevers after second covid vaccine.; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (Skin disorder/ Spots on middle of back) and PYREXIA (had really high fevers after second covid vaccine.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's relevant medical history was not reported.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received first 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 PYREXIA (had really high fevers after second covid vaccine.). On an unknown date, the patient experienced SKIN DISORDER (Skin disorder/ Spots on middle of back). In 2021, PYREXIA (had really high fevers after second covid vaccine.) had resolved. At the time of the report, SKIN DISORDER (Skin disorder/ Spots on middle of back) had not resolved.            Concomitant Drugs were not reported.  The patient had reported that she had really high fevers after second COVID vaccine. She had spot in middle of her back.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna
Sex: F
Vaccine: COVID19, UNK
Symptoms: Accidental overdose, No adverse event
Clinical narrative: Got full dose instead of half dose; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Got full dose instead of half dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product SUNITINIB MALATE (SUTENT) for Secondary malignant neoplasm of kidney.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and SUNITINIB MALATE (SUTENT) (unknown route) 37.5 milligram. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Got full dose instead of half dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Got full dose instead of half dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Got full dose instead of half dose).    Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flare up) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis and Hysterectomy (Patient had hysterectomy's surgery) in April 2021. Previously administered products included for Drug use for unknown indication: Humira. Past adverse reactions to the above products included No adverse event with Humira.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ARTHRITIS (Arthritis flare up). At the time of the report, ARTHRITIS (Arthritis flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient had hysterectomy's surgery in April 2021, one week after her birthday and that was recovered, stopped humira for 3 weeks prior to and after surgery. She took Moderna injection and 3 days after shot her arthritis had serious flareup. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 40-year-old female patient with relevant medical history of arthritis, who experienced the unexpected, non-serious  adverse event of special interest Arthritis (reported as Arthritis flare up) 3  days after receiving the first dose of mRNA-1273 vaccine.  Outcome of the event was reported as unknown. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of arthritis remains a confounder as arthritis is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 40-year-old female patient with relevant medical history of arthritis, who experienced the unexpected, non-serious  adverse event of special interest Arthritis (reported as Arthritis flare up) 3  days after receiving the first dose of mRNA-1273 vaccine.  Outcome of the event was reported as unknown. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of arthritis remains a confounder as arthritis is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 19.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs were not reported.  The reporter's causality for the event of sinus infection with Humira(Adalimumab) was no reasonable possibility.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity received in the Moderna were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: FELT SICK; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (FELT SICK) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Ankylosing spondylitis.    Concurrent medical conditions included Psoriatic arthritis and Ankylosing spondylitis.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (FELT SICK). At the time of the report, MALAISE (FELT SICK) had not resolved.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of FELT SICK was not provided.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Pain
Clinical narrative: Generalized aching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching) 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 UPADACITINIB (RINVOQ) 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Generalized aching) and HEADACHE (Headache). At the time of the report, PAIN (Generalized aching) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient experienced Achy body AND Headache after vaccination which was resolved on   On an unknown date. 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  received in the Moderna were missed to be booked-in  No treatment information was reported.
Age: 28.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chest discomfort, Oropharyngeal pain
Clinical narrative: Sore throat; Chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and CHEST DISCOMFORT (Chest tightness) in a 28-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.    No Medical History information was reported.   On 15-Oct-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) at an unspecified dose. In October 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and CHEST DISCOMFORT (Chest tightness). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and CHEST DISCOMFORT (Chest tightness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   In October 2021, the patient experienced sore throat and tightened chest. Moderna vaccine was also considered suspect.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Psoriasis, SARS-CoV-2 test, Tryptase
Clinical narrative: Localized itching/ ITCHING TORSO; PSORIASIS SCALY SPOTS COMING; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Localized itching/ ITCHING TORSO) and PSORIASIS (PSORIASIS SCALY SPOTS COMING) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    The patient's past medical history included Alcohol use (ALCOHOL USE (Stopped February 2020)) in February 2020, COVID-19 in November 2020, Tobacco user (TOBACCO USE (Stopped February 2020)) in February 2020 and Colonoscopy. Previously administered products included for Psoriasis: HUMIRA. Past adverse reactions to the above products included No adverse reaction with HUMIRA. Concurrent medical conditions included Itching since 2019. Concomitant products included PREDNISONE for Itching.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient experienced PRURITUS (Localized itching/ ITCHING TORSO) and PSORIASIS (PSORIASIS SCALY SPOTS COMING). At the time of the report, PRURITUS (Localized itching/ ITCHING TORSO) had resolved and PSORIASIS (PSORIASIS SCALY SPOTS COMING) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Tryptase: HIGH LEVELS OF TRIPTASE. In November 2020, SARS-CoV-2 test: (Positive) Positive.            Patient reports Itching torso and Psoriasis scaly spots coming back with SKYRIZI. The patient had a relevant medical history of Itching torso and Psoriasis scaly spots  The patient stated she got COVID 19 on Thanksgiving 2020.  She had the high levels of Triptaste in her blood and that could be Masto-cytosis, but she stated she had this problem prior to Skyrizi and it had not worsened since starting SkyRizi.  She stated her psoriasis had cleared up and after taking the first round of the Moderna her Psoriasis came back.  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 information was reported.
Age: 30.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eye inflammation
Clinical narrative: Eye inflamed/ Inflammed blood vessels around right eye.; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (Eye inflamed/ Inflammed blood vessels around right eye.) in a 30-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 Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose: Citrate free. On 09-Dec-2021, the patient experienced EYE INFLAMMATION (Eye inflamed/ Inflammed blood vessels around right eye.). At the time of the report, EYE INFLAMMATION (Eye inflamed/ Inflammed blood vessels around right eye.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs were not reported.  The reporter's causality for the event of inflammed blood vessels around right eye with Moderna vaccine was Probable.  The reporter's causality for the event of inflammed blood vessels around right eye with HUMIRA(Adalimumab)was no reasonable possibility.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of 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: Psoriasis
Clinical narrative: Psoriasis flare-up; This spontaneous case was reported by a non-health professional and describes the occurrence of PSORIASIS (Psoriasis flare-up) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 16-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 an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. 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 medication provided. No treatment information mentioned.  The patient got the covid vaccine five days before injecting Skyrizi and experienced a psoriasis flare and that her skin had not cleared since.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19, UNK
Symptoms: Furuncle, Pain, Vaccination site pain
Clinical narrative: Blood Boil; Sharp pain; Sore arm for few arms at the injection site after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Blood Boil), PAIN (Sharp pain) and VACCINATION SITE PAIN (Sore arm for few arms at the injection site after vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    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 FURUNCLE (Blood Boil), PAIN (Sharp pain) and VACCINATION SITE PAIN (Sore arm for few arms at the injection site after vaccine). At the time of the report, FURUNCLE (Blood Boil) and PAIN (Sharp pain) was resolving and VACCINATION SITE PAIN (Sore arm for few arms at the injection site after vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19
Clinical narrative: COVID-19; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and ARTHRALGIA (Aching joints) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF, UNK. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF, UNK. On an unknown date, the patient experienced COVID-19 (COVID-19) and ARTHRALGIA (Aching joints). At the time of the report, COVID-19 (COVID-19) outcome was unknown and ARTHRALGIA (Aching joints) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event Aching joints with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Nasopharyngitis
Clinical narrative: COVID-19; PATIENT VACCINATED AND STATED THAT IT WAS LIKE A BAD COLD; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and NASOPHARYNGITIS (PATIENT VACCINATED AND STATED THAT IT WAS LIKE A BAD COLD) in a 29-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 Crohn's disease.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced NASOPHARYNGITIS (PATIENT VACCINATED AND STATED THAT IT WAS LIKE A BAD COLD). In August 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved and NASOPHARYNGITIS (PATIENT VACCINATED AND STATED THAT IT WAS LIKE A BAD COLD) outcome 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. Reporter causality for COVID-19 was not related and not reported for Nasopharyngitis with Humira.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Immunodeficiency, Pyrexia
Clinical narrative: Immunocompromised; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunocompromised) in a 37-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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunocompromised) (seriousness criterion medically significant), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, IMMUNODEFICIENCY (Immunocompromised) outcome was unknown and FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.            No concomitant medications were reported. The patient experienced immunocompromised, fatigue, Fever after COVID-19 vaccine. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as solution for injection in pre-filled pen. The reporter causality for the events of immunocompromised, fatigue, Fever was  assessed as Not Reported for cosuspect humira. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns a 37  year  old, female patient, in treatment with Adalimumab for Rheumatoid arthritis, who received two doses of mRNA  1273 vaccine, and experienced the unexpected, serious medically significant event of immunodeficiency. Event onset date was not reported; hence latency and temporal association cannot be properly assessed. No further details were provided for medical reviewing. Co  suspect product Adalimumab, and Rheumatoid arthritis remains as contributors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 37  year  old, female patient, in treatment with Adalimumab for Rheumatoid arthritis, who received two doses of mRNA  1273 vaccine, and experienced the unexpected, serious medically significant event of immunodeficiency. Event onset date was not reported; hence latency and temporal association cannot be properly assessed. No further details were provided for medical reviewing.  product Adalimumab, and Rheumatoid arthritis remains as contributors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Feeling wiped out; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling wiped out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for CLL.    No Medical History information was reported.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VENETOCLAX (VENCLEXTA) (Oral) 200 milligram once a day. On 15-Dec-2021, the patient experienced FATIGUE (Feeling wiped out). At the time of the report, FATIGUE (Feeling wiped out) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Sex: F
Vaccine: COVID19, UNK
Symptoms: Contusion, Joint swelling
Clinical narrative: LEFT KNEE SWELLING; BRUISE ON WRIST with SKYRIZI (RISANKIZUMAB); This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (LEFT KNEE SWELLING) and CONTUSION (BRUISE ON WRIST with SKYRIZI (RISANKIZUMAB)) in an adult female 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 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (LEFT KNEE SWELLING) and CONTUSION (BRUISE ON WRIST with SKYRIZI (RISANKIZUMAB)). At the time of the report, JOINT SWELLING (LEFT KNEE SWELLING) and CONTUSION (BRUISE ON WRIST with SKYRIZI (RISANKIZUMAB)) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  On unknown dates, the patient experienced left knee swelling and bruise on wrist. moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. The patient stated that her left knee was swelling up. It was gotten bigger since she took covid vaccine last week in sep 2021. She also had a bruise on her wrist that was new. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 21-Sep-2021, patient received 1st dose covid-19 vaccine manufactured by moderna.  Causality for skyrizi (risankizumab) The reporter's causality for the event(s) of left knee swelling and bruise on wrist was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna
Sex: F
Vaccine: COVID19, UNK
Symptoms: Raynaud's phenomenon, Vaccination site pain
Clinical narrative: Raynaud's disease; Vaccination site pain; This spontaneous case was reported by a non-health professional and describes the occurrence of RAYNAUD'S PHENOMENON (Raynaud's disease) and VACCINATION SITE PAIN (Vaccination site pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RAYNAUD'S PHENOMENON (Raynaud's disease) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, RAYNAUD'S PHENOMENON (Raynaud's disease) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. The hands of the patient turned purple and had Raynaud's which was a long term chronic condition. She had soreness in arm after covid vaccination. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction, Nasopharyngitis
Clinical narrative: Vaccination adverse reaction; Common cold; Tiredness; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), NASOPHARYNGITIS (Common cold) and FATIGUE (Tiredness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Rheumatoid arthritis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 22-Jun-2016, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 Milligram, Solution for injection. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction), NASOPHARYNGITIS (Common cold) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction), NASOPHARYNGITIS (Common cold) and FATIGUE (Tiredness) had not resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded. 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: Adverse drug reaction
Clinical narrative: Adverse drug reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Adverse drug reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Adverse drug reaction). At the time of the report, ADVERSE DRUG REACTION (Adverse drug reaction) had resolved.            No concomitant products were reported.  On an unknown date, the patient experienced reaction to rinvoq after med covid shot. On an unknown date, reaction to rinvoq after med covid shot resolved. Moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 03-Mar-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 05-Apr-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna.  Causality for rinvoq (upadacitinib) The reporter's causality for the event(s) of reaction to rinvoq after med covid shot was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthropathy, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Arthropathy aggravated/right knee had a flare up during raining season; Fever; Headache; Vaccination site pain/had sore arm on first covid shot; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (Arthropathy aggravated/right knee had a flare up during raining season), VACCINATION SITE PAIN (Vaccination site pain/had sore arm on first covid shot), PYREXIA (Fever) and HEADACHE (Headache) 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 ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/had sore arm on first covid shot). In May 2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced ARTHROPATHY (Arthropathy aggravated/right knee had a flare up during raining season). In 2021, VACCINATION SITE PAIN (Vaccination site pain/had sore arm on first covid shot), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ARTHROPATHY (Arthropathy aggravated/right knee had a flare up during raining season) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-623287 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nightmare, Skin ulcer
Clinical narrative: Nightmare outbreak from covid-19 shot; Open sores on legs; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Nightmare outbreak from covid-19 shot) and SKIN ULCER (Open sores on legs) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NIGHTMARE (Nightmare outbreak from covid-19 shot) and SKIN ULCER (Open sores on legs). At the time of the report, NIGHTMARE (Nightmare outbreak from covid-19 shot) and SKIN ULCER (Open sores on legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of NIGHTMARE OUTBREAK FROM COVID-19 SHOT with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of OPEN SORES ON LEGS 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: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pruritus, Skin fissures
Clinical narrative: Hands and feet itchy; Hands and feet splitting/cracking; This spontaneous case was reported by a non-health professional and describes the occurrence of SKIN FISSURES (Hands and feet splitting/cracking) and PRURITUS (Hands and feet itchy) in a 62-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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SKIN FISSURES (Hands and feet splitting/cracking). On an unknown date, the patient experienced PRURITUS (Hands and feet itchy). At the time of the report, SKIN FISSURES (Hands and feet splitting/cracking) and PRURITUS (Hands and feet itchy) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient did not thought Skyrizi was working. He still experienced hands/feet splitting and cracking caused by the Moderna Covid vaccines and booster. His hands and feet still were itchy.  Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.