chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: RASH ON ARM WHERE THE COVID BOOSTER INJECTION GIVEN; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (RASH ON ARM WHERE THE COVID BOOSTER INJECTION GIVEN) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukemia.    Previously administered products included for Drug use for unknown indication: LISINOPRIL. Past adverse reactions to the above products included Drug allergy with LISINOPRIL. Concurrent medical conditions included Drug allergy (LISINOPRIL ALLERGY).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient experienced VACCINATION SITE RASH (RASH ON ARM WHERE THE COVID BOOSTER INJECTION GIVEN). At the time of the report, VACCINATION SITE RASH (RASH ON ARM WHERE THE COVID BOOSTER INJECTION GIVEN) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of vaccination site rash was not provided with IMBRUVICA  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Blood pressure high; Injection site itching; Injection site swelling; Injection site redness; Injection site rash; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood pressure high), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE RASH (Injection site rash) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis.    Concurrent medical conditions included Psoriatic arthritis and Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced HYPERTENSION (Blood pressure high), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE RASH (Injection site rash). At the time of the report, HYPERTENSION (Blood pressure high) had resolved and INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE RASH (Injection site rash) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  Injection site itching, Injection site swelling, Injection site redness, Injection site rash reported as worsened.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of itching at injection site, swelling at injection site, red at injection site and rash at injection site with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event of high blood pressure with humira(adalimumab) was no reasonable possibility.   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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Pharyngeal swelling
Clinical narrative: Exacerbation of asthma; Throat swelling after taking the 1st dose of Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Exacerbation of asthma) and PHARYNGEAL SWELLING (Throat swelling after taking the 1st dose of Moderna Covid vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Asthma.    No Medical History information was reported.   In February 2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelling after taking the 1st dose of Moderna Covid vaccine). On an unknown date, the patient experienced ASTHMA (Exacerbation of asthma). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat swelling, at an unspecified dose and frequency. On 02-Dec-2021, PHARYNGEAL SWELLING (Throat swelling after taking the 1st dose of Moderna Covid vaccine) had resolved. At the time of the report, ASTHMA (Exacerbation of asthma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. On 22-SEP-2021 the patient gone to the emergency room for treatment of an asthma exacerbation while she was off the medication (asthma) following the first dose intake. Currently patient was on a steroid taper and had just ended nebulization treatments for asthma. Patient took Diphenhydramine hydrochloride (Benadryl) for 2 days to treat throat swelling.  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: Urticaria
Clinical narrative: WEIRD ALLERGY HIVES; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (WEIRD ALLERGY HIVES) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced URTICARIA (WEIRD ALLERGY HIVES). At the time of the report, URTICARIA (WEIRD ALLERGY HIVES) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment information was provided.  The reporter's causality for the event of Urticaria  with  Humira was a 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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Immunisation reaction, Musculoskeletal stiffness, Neck pain
Clinical narrative: Left arm stiffness could not lift; Left arm stiffness could not lift; Bad reaction to covid shot; Vaccination site induration; Chest pain; Neck pain; Back pain; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Back pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm stiffness could not lift), CHEST PAIN (Chest pain), NECK PAIN (Neck pain) and MUSCULOSKELETAL STIFFNESS (Left arm stiffness could not lift) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced BACK PAIN (Back pain), CHEST PAIN (Chest pain) and NECK PAIN (Neck pain). In August 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm stiffness could not lift), MUSCULOSKELETAL STIFFNESS (Left arm stiffness could not lift), IMMUNISATION REACTION (Bad reaction to covid shot) and VACCINATION SITE INDURATION (Vaccination site induration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In 2021, BACK PAIN (Back pain), CHEST PAIN (Chest pain) and NECK PAIN (Neck pain) had resolved. In August 2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm stiffness could not lift), MUSCULOSKELETAL STIFFNESS (Left arm stiffness could not lift), IMMUNISATION REACTION (Bad reaction to covid shot) and VACCINATION SITE INDURATION (Vaccination site induration) had resolved.            No concomitant medications were reported.  On 01-AUG-2021, the patient received Booster dose/ 3rd dose of Moderna vaccine.  Reporter did not have the lot number information, because the packaging was discarded. 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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site movement impairment
Clinical narrative: Left arm stiffness could not lift; Left arm stiffness could not lift; Bad reaction to covid shot; Vaccination site induration; Chest pain; Neck pain; Back pain; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Back pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm stiffness could not lift), CHEST PAIN (Chest pain), NECK PAIN (Neck pain) and MUSCULOSKELETAL STIFFNESS (Left arm stiffness could not lift) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced BACK PAIN (Back pain), CHEST PAIN (Chest pain) and NECK PAIN (Neck pain). In August 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm stiffness could not lift), MUSCULOSKELETAL STIFFNESS (Left arm stiffness could not lift), IMMUNISATION REACTION (Bad reaction to covid shot) and VACCINATION SITE INDURATION (Vaccination site induration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In 2021, BACK PAIN (Back pain), CHEST PAIN (Chest pain) and NECK PAIN (Neck pain) had resolved. In August 2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Left arm stiffness could not lift), MUSCULOSKELETAL STIFFNESS (Left arm stiffness could not lift), IMMUNISATION REACTION (Bad reaction to covid shot) and VACCINATION SITE INDURATION (Vaccination site induration) had resolved.            No concomitant medications were reported.  On 01-AUG-2021, the patient received Booster dose/ 3rd dose of Moderna vaccine.  Reporter did not have the lot number information, because the packaging was discarded. 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: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry eye, Eye pain, Neuropathy peripheral
Clinical narrative: Eye pain; Eyes dry; Painful joints; Peripheral neuropathy aggravated; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy aggravated) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.  Concurrent medical conditions included Rheumatoid arthritis.  On 15-Oct-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 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) Citrate free. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy aggravated) (seriousness criterion medically significant), DRY EYE (Eyes dry), EYE PAIN (Eye pain) and ARTHRALGIA (Painful joints). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy aggravated), DRY EYE (Eyes dry), EYE PAIN (Eye pain) and ARTHRALGIA (Painful joints) was resolving.     No concomitant medications were reported.  It was reported that, the patient had dryer eyes, neuropathy was worse, pain in joints and eye got hurt.  it was unknown if patient was enrolled in a covid 19 vaccine trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an elderly female patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral (reported as Peripheral neuropathy aggravated), unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Sender's Comments: This spontaneous case concerns an elderly female patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral (reported as Peripheral neuropathy aggravated), unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Musculoskeletal stiffness, Pain
Clinical narrative: Joint inflammation; Pain; Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Joint inflammation), PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (Stiffness) 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 Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 01-Nov-2021, the patient received 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) On an unknown date, the patient experienced ARTHRITIS (Joint inflammation), PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, ARTHRITIS (Joint inflammation) had resolved, PAIN (Pain) had not resolved and MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving.            No concomitant product was reported. No treatment information was reported. For event Joint inflammation, Dechallenge with suspect was reported as Yes. No rechallenge was done. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality with Humira for the event Joint inflammation was no reasonable possibility and for event Pain was 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Mobility decreased, Rheumatoid arthritis
Clinical narrative: Eye inflammation; Mobility decreased; Rheumatoid arthritis aggravated; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated/THE COVID VACCINE MADE OF BROUGHT RHEUMATOID ARTHRITIS TO THE FOREFRONT) in a 61-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.  Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In March 2021, the patient experienced EYE INFLAMMATION (Eye inflammation). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated/THE COVID VACCINE MADE OF BROUGHT RHEUMATOID ARTHRITIS TO THE FOREFRONT) (seriousness criterion medically significant) and MOBILITY DECREASED (Mobility decreased/ WOKE UP UNABLE TO MOVE). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated/THE COVID VACCINE MADE OF BROUGHT RHEUMATOID ARTHRITIS TO THE FOREFRONT) and MOBILITY DECREASED (Mobility decreased/ WOKE UP UNABLE TO MOVE) outcome was unknown and EYE INFLAMMATION (Eye inflammation) was resolving.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were reported. 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 61-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Reporter did not allow further contact  Sender's Comments: This spontaneous case concerns a 61-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for 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) at an unspecified dose. In November 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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 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.  Company comment: This spontaneous case concerns a 59-years-old male patient, with concurrent medical condition of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine. SARS-CoV-2 test was Positive as on unspecified date. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was resolved. Non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis could be the risk factor for the event. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 59-years-old male patient, with concurrent medical condition of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine. SARS-CoV-2 test was Positive as on unspecified date. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was resolved. Non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis could be the risk factor for the event. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Hidradenitis, Vaccination site pain
Clinical narrative: Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms; Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms; Dizziness; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Vaccination site pain) in a 43-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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-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) UNK, Citrate Free. On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms) had not resolved and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided          No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Psoriasis
Clinical narrative: Minor psoriasis flare ups; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (Minor psoriasis flare ups) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Minor psoriasis flare ups). At the time of the report, PSORIASIS (Minor psoriasis flare ups) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant product was reported. The patient was on Humira and he had an allergic reaction to the Humira, his whole body turned red. When he got his vaccinations, he did have minor psoriasis flare ups. He still had a few patches here and there. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction/ A squished circle the size of the band aid at site of injection in leg with Humira; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Injection site reaction/ A squished circle the size of the band aid at site of injection in leg with Humira) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Allergy to vaccine.   On 01-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Feb-2022, received second dose of mRNA-1273 (Spikevax) (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 INJECTION SITE REACTION (Injection site reaction/ A squished circle the size of the band aid at site of injection in leg with Humira). At the time of the report, INJECTION SITE REACTION (Injection site reaction/ A squished circle the size of the band aid at site of injection in leg with Humira) was resolving.        The action taken with mRNA-1273 (Spikevax) (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 reporter's causality for the event(s) of a squished circle the size of the band aid at site of injection  in leg with Humira (adalimumab) was a reasonable possibility.  No concomitant medication reported. No treatment medication reported.  Primary reporter did not had the lot number information, because the packaging was discarded.  It was unknown if patient was enrolled in a COVID-19 vaccine trail.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Oral herpes, White blood cell count
Clinical narrative: Have fever blisters from the Moderna Booster; Muscle spasms in back; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Have fever blisters from the Moderna Booster) and MUSCLE SPASMS (Muscle spasms in back) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for an unknown indication.    Concurrent medical conditions included Malignant neoplasm of female breast, unspecified.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and PALBOCICLIB (IBRANCE) (Oral) 100 milligram. In April 2021, the patient experienced MUSCLE SPASMS (Muscle spasms in back). On an unknown date, the patient experienced ORAL HERPES (Have fever blisters from the Moderna Booster). The patient was treated with DIAZEPAM (VALIUM) in April 2021 for Muscle spasm, at an unspecified dose and frequency and NALOXONE HYDROCHLORIDE (NARCAN) in April 2021 at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Have fever blisters from the Moderna Booster) and MUSCLE SPASMS (Muscle spasms in back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 2.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported that Ibrance started  over a year ago, pharmacy first shipped ibrance to patient on 11/04/2021. 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: COVID-19, Malaise
Clinical narrative: COVID-19; Feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) and COVID-19 (COVID-19) in an elderly male patient who received mRNA-1273 for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    No Medical History information was reported.   In February 2022, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. In February 2022, the patient experienced COVID-19 (COVID-19). In 2022, the patient experienced MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) and COVID-19 (COVID-19) had not resolved.     The action taken with mRNA-1273(Intramuscular) was unknown.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, COVID-19
Clinical narrative: Vascular issue; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and ANGIOPATHY (Vascular issue) 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.  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. In January 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 17-Feb-2022, 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 November 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ANGIOPATHY (Vascular issue). At the time of the report, COVID-19 (COVID-19) had resolved and ANGIOPATHY (Vascular issue) was resolving.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: Chronic plaque psoriasis flare up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Chronic plaque psoriasis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Chronic plaque psoriasis flare up). At the time of the report, PSORIASIS (Chronic plaque psoriasis flare up) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site mass, SARS-CoV-2 test
Clinical narrative: Injection site lump; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INJECTION SITE MASS (Injection site lump) in a 63-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.    There was no reported medical history.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In January 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INJECTION SITE MASS (Injection site lump). At the time of the report, COVID-19 (COVID-19) was resolving and INJECTION SITE MASS (Injection site lump) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 24.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Fatigue, Psoriasis
Clinical narrative: After second COVID vaccine did felt fatigued and weak; when weather changed start plaque psoriasis small spots; After second COVID vaccine did felt fatigued and weak; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (After second COVID vaccine did felt fatigued and weak), PSORIASIS (when weather changed start plaque psoriasis small spots) and FATIGUE (After second COVID vaccine did felt fatigued and weak) in an adult 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.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 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. On an unknown date, the patient experienced ASTHENIA (After second COVID vaccine did felt fatigued and weak), PSORIASIS (when weather changed start plaque psoriasis small spots) and FATIGUE (After second COVID vaccine did felt fatigued and weak). At the time of the report, ASTHENIA (After second COVID vaccine did felt fatigued and weak) and FATIGUE (After second COVID vaccine did felt fatigued and weak) outcome was unknown and PSORIASIS (when weather changed start plaque psoriasis small spots) had resolved.            No concomitant medications were reported. No treatment medications 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.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Contusion, Ecchymosis, Headache, Herpes simplex
Clinical narrative: Herpes simplex virus; Ecchymosis on extremities; Bruising on arms and legs; Sores on lips; Headache when walking in the morning; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (Herpes simplex virus), ECCHYMOSIS (Ecchymosis on extremities), CONTUSION (Bruising on arms and legs), CHEILITIS (Sores on lips) and HEADACHE (Headache when walking in the morning) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Lymphocytic lymphoma.    No Medical History information was reported.   On 05-Apr-2022, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced HERPES SIMPLEX (Herpes simplex virus), ECCHYMOSIS (Ecchymosis on extremities), CONTUSION (Bruising on arms and legs), CHEILITIS (Sores on lips) and HEADACHE (Headache when walking in the morning). At the time of the report, HERPES SIMPLEX (Herpes simplex virus) and ECCHYMOSIS (Ecchymosis on extremities) had not resolved, CONTUSION (Bruising on arms and legs) and CHEILITIS (Sores on lips) outcome was unknown and HEADACHE (Headache when walking in the morning) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of HERPES SIMPLEX VIRUS, HEADACHE WHEN WAKING IN THE MORNING and ECCHYMOSIS ON EXTREMETIES with IMBRUVICA(IBRUTINIB) was a reasonable possibility. The reporter's causality for the events of BRUISING ON ARMS AND LEGS and SORES ON LIPS was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of 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 ELAGOLIX SODIUM (ORILISSA) 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 ELAGOLIX SODIUM (ORILISSA) (Oral) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  On an unknown date, the patient received Moderna COVID-19 vaccine and experienced headache. Patient had headache and she took Excedrin. She had off Excedrin a week and a half because she had not been able to take it and now she was having withdrawals at the time of report.  It was unknown if she 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hepatic enzyme increased, Vaccination site pain
Clinical narrative: Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) in a 61-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 Ulcerative colitis.    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 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-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 VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness). The patient was treated with URSODIOL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme increased: High.         No concomitant medications was reported.  It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite
Clinical narrative: COVID-19; Appetite absent; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DECREASED APPETITE (Appetite absent) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2022, 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) Citrate free. On an unknown date, the patient experienced COVID-19 (COVID-19) and DECREASED APPETITE (Appetite absent). At the time of the report, COVID-19 (COVID-19) had resolved and DECREASED APPETITE (Appetite absent) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality of Humira as per reporter for event COVID-19 was No reasonable possibility and for event Appetite absent was Not reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Vaccination site pain
Clinical narrative: Cough; SORE ARM AFTER FIRST TWO COVID SHOTS; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and VACCINATION SITE PAIN (SORE ARM AFTER FIRST TWO COVID SHOTS) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AFTER FIRST TWO COVID SHOTS). On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) was resolving and VACCINATION SITE PAIN (SORE ARM AFTER FIRST TWO COVID SHOTS) had resolved.            No concomitant medication was reported.   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-2022-621168 (Patient Link).