chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Varicose vein
Clinical narrative: Color of skin was changing possibly from varicose veins; Color of skin was changing possibly from varicose veins; Loses sleep; Stiff; Aching down legs/ thigh/ behind the knee hurts bad and in front; Aching down legs/ thigh/ behind the knee hurts bad and in front; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching down legs/ thigh/ behind the knee hurts bad and in front), SKIN DISCOLOURATION (Color of skin was changing possibly from varicose veins), VARICOSE VEIN (Color of skin was changing possibly from varicose veins), INSOMNIA (Loses sleep) and MUSCULOSKELETAL STIFFNESS (Stiff) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-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) at an unspecified dose. On 07-Dec-2021, the patient experienced PAIN (Aching down legs/ thigh/ behind the knee hurts bad and in front) and ARTHRALGIA (Aching down legs/ thigh/ behind the knee hurts bad and in front). On an unknown date, the patient experienced SKIN DISCOLOURATION (Color of skin was changing possibly from varicose veins), VARICOSE VEIN (Color of skin was changing possibly from varicose veins), INSOMNIA (Loses sleep) and MUSCULOSKELETAL STIFFNESS (Stiff). At the time of the report, PAIN (Aching down legs/ thigh/ behind the knee hurts bad and in front), SKIN DISCOLOURATION (Color of skin was changing possibly from varicose veins), VARICOSE VEIN (Color of skin was changing possibly from varicose veins), INSOMNIA (Loses sleep), MUSCULOSKELETAL STIFFNESS (Stiff) and ARTHRALGIA (Aching down legs/ thigh/ behind the knee hurts bad and in front) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of aching down legs/ thigh/ behind the knee hurts bad and in front with Humira was no reasonable possibility, for the events of color of skin was changing possibly from varicose vein, loses sleep and stiff was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Chills, Pain
Clinical narrative: Unilateral carpal tunnel syndrome; Pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CARPAL TUNNEL SYNDROME (Unilateral carpal tunnel syndrome), PAIN (Pain) and CHILLS (Chills) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced CARPAL TUNNEL SYNDROME (Unilateral carpal tunnel syndrome), PAIN (Pain) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, CARPAL TUNNEL SYNDROME (Unilateral carpal tunnel syndrome) was resolving and PAIN (Pain) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of carpal tunnel on hand, aches pains chills due to vaccine unknown onset and aches pains chills due to vaccine unknown onset with humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nasopharyngitis
Clinical narrative: Feelings of weakness/Felt weak; Cold symptoms/Symptoms similar to cold; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feelings of weakness/Felt weak) and NASOPHARYNGITIS (Cold symptoms/Symptoms similar to cold) in a 51-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 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced ASTHENIA (Feelings of weakness/Felt weak) and NASOPHARYNGITIS (Cold symptoms/Symptoms similar to cold). At the time of the report, ASTHENIA (Feelings of weakness/Felt weak) was resolving and NASOPHARYNGITIS (Cold symptoms/Symptoms similar to cold) 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 events of asthenia and nasopharyngitis with HUMIRA(ADALIMUMAB) was a 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.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated
Clinical narrative: FLARE UPS AFTER RECEIVING SECOND DOSE OF MODERNA COVID 19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UPS AFTER RECEIVING SECOND DOSE OF MODERNA COVID 19 VACCINE) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UPS AFTER RECEIVING SECOND DOSE OF MODERNA COVID 19 VACCINE). At the time of the report, CONDITION AGGRAVATED (FLARE UPS AFTER RECEIVING SECOND DOSE OF MODERNA COVID 19 VACCINE) outcome was unknown.            No concomitant medications were reported.  On an unknown date, the patient experienced flare ups after receiving second dose of Moderna COVID-19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of condition aggravated was not provided with HUMIRA(ADALIMUMAB).  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: 51.0
Sex: F
Vaccine: COVID19, UNK
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 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced COVID-19 (COVID-19). In 2022, COVID-19 (COVID-19) had resolved.            Concomitant products were not provided. Treatment medication were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  In Jan 2022, patient got COVID and had high fever, sore throat, fatigue and headache. fever lasted five days and symptoms coughing lasted about a month.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hidradenitis, Rash
Clinical narrative: hidradenitis suppurativa flare up on buttocks cheek and bikini line; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (hidradenitis suppurativa flare up on buttocks cheek and bikini line) and RASH (Rash) in a 42-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 Hidradenitis suppurativa.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced HIDRADENITIS (hidradenitis suppurativa flare up on buttocks cheek and bikini line). In 2021, RASH (Rash) had resolved. At the time of the report, HIDRADENITIS (hidradenitis suppurativa flare up on buttocks cheek and bikini line) had resolved.            It was unknown if the patient was enrolled in covid-19 vaccine trials.  No concomitant product reported by reporter. No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Headache
Clinical narrative: Did not feel right; Headache; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel right), HEADACHE (Headache) and CONDITION AGGRAVATED (Condition aggravated) 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 Rheumatoid arthritis and Ulcerative colitis.    No Medical History information was reported.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 17-Dec-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated). On an unknown date, the patient experienced FEELING ABNORMAL (Did not feel right) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Did not feel right), HEADACHE (Headache) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product reported by reporter. No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hiatus hernia, Nephrolithiasis, Oesophagitis
Clinical narrative: Kidney stones; Hiatal hernia; Esophagitis; Painful joints; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stones) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stones) (seriousness criterion medically significant), HIATUS HERNIA (Hiatal hernia), OESOPHAGITIS (Esophagitis) and ARTHRALGIA (Painful joints). At the time of the report, NEPHROLITHIASIS (Kidney stones), HIATUS HERNIA (Hiatal hernia), OESOPHAGITIS (Esophagitis) and ARTHRALGIA (Painful joints) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medications were 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  Company comment  This spontaneous case reported by a consumer, concerns an elderly female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of NEPHROLITHIASIS (Kidney stones) unknown days after receiving a dose of Moderna mRNA1273 vaccine, in the covid 19 vaccination series, along with other non serious events. It was reported that the patient had received  ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. The outcome of the events was unknown. 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 reported by a consumer, concerns an elderly female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of NEPHROLITHIASIS (Kidney stones) unknown days after receiving a dose of Moderna mRNA1273 vaccine, in the covid 19 vaccination series, along with other non serious events. It was reported that the patient had received  ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. The outcome of the events was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Pain in jaw
Clinical narrative: JAW PAIN; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (JAW PAIN), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Jaw operation. Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN JAW (JAW PAIN), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, PAIN IN JAW (JAW PAIN) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) 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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All dose of COVID-19 vaccine including booster taken one in once.   Patient reported had jaw surgery and was recovering at the time of report. Had some pain but overall doing good.  No treatment drug information was provided.  The reporter's causality for the event(s) of jaw surgery and jaw pain with PFIZER BIONTECH COVID-19 VACCINE was probable.  The reporter's causality for the event(s) of jaw surgery and jaw pain with humira (adalimumab) was no reasonable possibility.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Received 2 dose of Moderna covid-19 vaccine as well as Moderna booster dose; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received 2 dose of Moderna covid-19 vaccine as well as Moderna booster dose) and DRUG INEFFECTIVE (Lack of efficacy) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received 2 dose of Moderna covid-19 vaccine as well as Moderna booster dose) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Received 2 dose of Moderna covid-19 vaccine as well as Moderna booster dose) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.            Paxlovid was prescribed. No concomitant treatment information was provided by the reporter.  Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. Patient received 3 doses of mRNA-1273 vaccine. The onset date of the event and the vaccination dates were not reported, hence latency cannot be assessed, and lack of efficacy cannot be concluded in this case. Paxlovid was prescribed. Clinical course was not reported. The outcome of event was unknown. Current COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. Patient received 3 doses of mRNA-1273 vaccine. The onset date of the event and the vaccination dates were not reported, hence latency cannot be assessed, and lack of efficacy cannot be concluded in this case. Paxlovid was prescribed. Clinical course was not reported. The outcome of event was unknown. Current COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Takes injection every week now rather than every two weeks; Vaccine caused sore arm; Fatigue on the booster; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Takes injection every week now rather than every two weeks), VACCINATION SITE PAIN (Vaccine caused sore arm) and FATIGUE (Fatigue on the booster) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.  No Medical History information was reported.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-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) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Takes injection every week now rather than every two weeks), VACCINATION SITE PAIN (Vaccine caused sore arm) and FATIGUE (Fatigue on the booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Takes injection every week now rather than every two weeks) was resolving and VACCINATION SITE PAIN (Vaccine caused sore arm) and FATIGUE (Fatigue on the booster) had resolved.    No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Aug-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  In Aug-2021, patient experienced Rheumatoid arthritis flare up on whole body. It was unknown if patient was enrolled in COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna  were missed to be booked-in.  Company comment: This spontaneous case concerns a 71 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose (dosing number unclear) of mRNA-1273 vaccine in the COVID-19 vaccination series. The event resolved. No information on exact date of the event, detailed clinical course and relevant investigations was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-624812 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose (dosing number unclear) of mRNA-1273 vaccine in the COVID-19 vaccination series. The event resolved. No information on exact date of the event, detailed clinical course and relevant investigations was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Psoriasis
Clinical narrative: Flu like symptoms; Plaque psoriasis small breaks on outside of left thigh/psoriasis flare-up; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PSORIASIS (Plaque psoriasis small breaks on outside of left thigh/psoriasis flare-up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an elderly 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PSORIASIS (Plaque psoriasis small breaks on outside of left thigh/psoriasis flare-up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and PSORIASIS (Plaque psoriasis small breaks on outside of left thigh/psoriasis flare-up) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hidradenitis
Clinical narrative: hidradenitis suppurativa worsening/hidradenitis suppurativa flare up; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (hidradenitis suppurativa worsening/hidradenitis suppurativa flare up) and FATIGUE (Fatigue) in a 30-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) solution for injection for Hidradenitis suppurativa.    The patient's past medical history included Hidradenitis suppurativa.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-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 FATIGUE (Fatigue). On an unknown date, the patient experienced HIDRADENITIS (hidradenitis suppurativa worsening/hidradenitis suppurativa flare up). At the time of the report, HIDRADENITIS (hidradenitis suppurativa worsening/hidradenitis suppurativa flare up) had not resolved and FATIGUE (Fatigue) had resolved.            No concomitant medication were reported. 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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient took first dose on 30Mar2021 and second dose on 20Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 30Mar2021 and second dose on 20Apr2021) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Psoriasis.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 30Mar2021 and second dose on 20Apr2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 30Mar2021 and second dose on 20Apr2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            In March 2021, the patient experienced not taken prescription due to taking vaccines/patient took the covid booster shot and did not want to take humira. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 30-Mar-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 20-Apr-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna, on 20-Oct-2021, patient received 3rd dose covid-19 vaccine manufactured by moderna, primary reporter declined to be contacted.   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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pruritus, Suspected COVID-19
Clinical narrative: Itching at injection site; Moderna 1st dose: 10-Sep-2021 and 2nd Dose: 01-Oct-2021; Suspected COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at injection site), SUSPECTED COVID-19 (Suspected COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 10-Sep-2021 and 2nd Dose: 01-Oct-2021) in a 58-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.    The patient's past medical history included Chronic kidney disease stage 4 in 2019, Thoracic vertebral fracture T11 in 2011, Gout in 2020, Reduced general condition (nothing to do with her medication) in 2019, COVID-19 in November 2019 and Intraocular lens replacement in 2019. Concurrent medical conditions included Chronic kidney disease stage 3 since 29-Oct-2021 and Rheumatoid arthritis.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous)  In 2021, the patient experienced SUSPECTED COVID-19 (Suspected COVID-19). On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 10-Sep-2021 and 2nd Dose: 01-Oct-2021). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itching at injection site). At the time of the report, INJECTION SITE PRURITUS (Itching at injection site), SUSPECTED COVID-19 (Suspected COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 1st dose: 10-Sep-2021 and 2nd Dose: 01-Oct-2021) outcome was unknown.            No concomitant medication was reported.  Patient had rheumatoid arthritis and other two issue had her body tried to give up. On an unknown date, patient had another issue. When patient took both COVID vaccines, patient got all the COVID symptoms. Patient reported other than injection site reaction she had no issues. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for COVID symptoms, itching at injection site with co-suspect Humira 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriasis and Psoriatic arthritis.   On 02-Sep-2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In November 2021, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the event of COVID was not provided for Humira.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2022: Significant Live follow up appended : updates to suspect drug information.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Memory impairment, Nausea, Pain, Vomiting
Clinical narrative: Memory not good; Throwing up on and off for two weeks; Nauseous; Lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lot of pain), MEMORY IMPAIRMENT (Memory not good), VOMITING (Throwing up on and off for two weeks) and NAUSEA (Nauseous) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2021, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Lot of pain). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory not good), VOMITING (Throwing up on and off for two weeks) and NAUSEA (Nauseous). At the time of the report, PAIN (Lot of pain) and MEMORY IMPAIRMENT (Memory not good) had not resolved and VOMITING (Throwing up on and off for two weeks) and NAUSEA (Nauseous) had resolved.            Concomitant product use was not provided by the reporter.  The patient had lot of pain due to being without Rinvoq almost a month, did not remember the last time when patient had medication. Patient's memory was not good. After second Covid-19 vaccine, patient was nauseous and throwing up on and off for two weeks. Patient's first and third vaccine had no issues. Patient had started back on Rinvoq in last week in Dec-2021.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality for the events of lot of pain with Rinvoq was reported as a reasonable possibility, for event of memory not good was not provided and for the events of throwing up on and off for two weeks and nauseous was no reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Pyrexia
Clinical narrative: Arthropod bite; Anytime when got a bug bite or tick bite it was slow to heal; psoriasis flare-up on elbows, knees and right eyelid; temperature of 101.9; Swelling of wrists; Flare up in all joints after took first covid vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling of wrists), ARTHROPATHY (Flare up in all joints after took first covid vaccine.), ARTHROPOD BITE (Arthropod bite), IMPAIRED HEALING (Anytime when got a bug bite or tick bite it was slow to heal) and PSORIASIS (psoriasis flare-up on elbows, knees and right eyelid) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthropathy and Plaque psoriasis.    No other medical history was reported.  Concomitant products included CYCLOBENZAPRINE HCL, CALCITRIOL, TRAMADOL HCL, CLOBETASOL PROPIONATE, NAPROXEN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   In 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg,1 in 2 wk. On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Dec-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg,1 in 2 wk. In October 2021, the patient experienced ARTHROPATHY (Flare up in all joints after took first covid vaccine.). On an unknown date, the patient experienced JOINT SWELLING (Swelling of wrists), ARTHROPOD BITE (Arthropod bite), IMPAIRED HEALING (Anytime when got a bug bite or tick bite it was slow to heal), PSORIASIS (psoriasis flare-up on elbows, knees and right eyelid) and PYREXIA (temperature of 101.9). In 2021, ARTHROPATHY (Flare up in all joints after took first covid vaccine.) had resolved. At the time of the report, JOINT SWELLING (Swelling of wrists) had not resolved and ARTHROPOD BITE (Arthropod bite), IMPAIRED HEALING (Anytime when got a bug bite or tick bite it was slow to heal), PSORIASIS (psoriasis flare-up on elbows, knees and right eyelid) and PYREXIA (temperature of 101.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101.9 No unit Abnormal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       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 medication was provided. Since 2012, the patient had been taking Humira and stopped it in Jun 2021 because he was diagnosed with covid infection on 09 Jul 2021. He was hospitalized for five days with covid.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of COVID, temperature was 101.9 after took first COVID VACCINE, Anytime when got a bug bite or tick bite it was slow to heal unknown onset was not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Gastrooesophageal reflux disease, Headache, Lactose intolerance
Clinical narrative: Lactose intolerant; Acid reflux; Loss of appetite; Headache; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LACTOSE INTOLERANCE (Lactose intolerant), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and PYREXIA (Low grade fever) in an adult 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 Crohn's disease.    No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received 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 DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue). On an unknown date, the patient experienced LACTOSE INTOLERANCE (Lactose intolerant) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). In 2021, DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue) had resolved. At the time of the report, LACTOSE INTOLERANCE (Lactose intolerant) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) had not resolved.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality for the events of lactose intolerant, headaches, acid reflux, low grade fever, loss of appetite and fatigue with Humira was no reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lactose intolerant; Acid reflux; Loss of appetite; Headache; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LACTOSE INTOLERANCE (Lactose intolerant), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and PYREXIA (Low grade fever) in an adult 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 Crohn's disease.    No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received 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 DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue). On an unknown date, the patient experienced LACTOSE INTOLERANCE (Lactose intolerant) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). In 2021, DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue) had resolved. At the time of the report, LACTOSE INTOLERANCE (Lactose intolerant) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) had not resolved.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality for the events of lactose intolerant, headaches, acid reflux, low grade fever, loss of appetite and fatigue with Humira was no reasonable possibility.  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.