chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2
Clinical narrative: PATIENTS ENTIRE FAMILY HAD COVID-19/ Exposure to COVID-19; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (PATIENTS ENTIRE FAMILY HAD COVID-19/ Exposure to COVID-19) and COVID-19 (COVID-19) 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 an unknown indication.    No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (PATIENTS ENTIRE FAMILY HAD COVID-19/ Exposure to COVID-19) and COVID-19 (COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (PATIENTS ENTIRE FAMILY HAD COVID-19/ Exposure to COVID-19) outcome was unknown and COVID-19 (COVID-19) was resolving.            Relevant concomitant medications were not reported.  On 14-Apr-2021, patient received first dose COVID-19 vaccine manufactured by Moderna. On 17-May-2021, patient received second dose COVID-19 vaccine manufactured by Moderna. On unknown date, patient's entire family had COVID-19 and patient experienced COVID-19.  Treatment information was not provided.  The reporter's causality for the event of patient's entire family had COVID-19 was not provided. The reporter's causality for the event of COVID-19 with HUMIRA(ADALIMUMAB) was a reasonable possibility.  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, Sleep apnoea syndrome
Clinical narrative: COVID-19; Sleep apnea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and SLEEP APNOEA SYNDROME (Sleep apnea) in an adult female patient who received mRNA-1273 (Spikevax) 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 first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced COVID-19 (COVID-19) and SLEEP APNOEA SYNDROME (Sleep apnea). At the time of the report, COVID-19 (COVID-19) and SLEEP APNOEA SYNDROME (Sleep apnea) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.   The reporter's causality for the events of sleep apnea and COVID-19 with Humira (adalimumab) was no reasonable possibility. The reporter assessed events of sleep apnea and COVID-19 as possibly related to Moderna COVID-19 vaccine.  No treatment details 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to vaccine/ Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergy to vaccine/ Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No relevant medical history was reported.  Previously administered products included for Product used for unknown indication: Polyethylene Glycol. Past adverse reactions to the above products included No adverse event with Polyethylene Glycol. Concurrent medical conditions included Polyethylene glycol allergy.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 01-Jan-2022, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine/ Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol). On 03-May-2022, ALLERGY TO VACCINE (Allergy to vaccine/ Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  No concomitant medication reported. No treatment medication reported.  The reporter causality for the Co-suspect Humira for the Event Allergic reaction to COVID  vaccine shot that had Polyethylene Glycol was not provided.  Primary reporter contact for lot number information was unsuccessful.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Herpes zoster, Therapeutic product effect incomplete, Vaccination site pain
Clinical narrative: Low back pain; Shingles; Drug effect incomplete; Painful hips; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Low back pain), HERPES ZOSTER (Shingles), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), ARTHRALGIA (Painful hips) and VACCINATION SITE PAIN (Vaccination site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced BACK PAIN (Low back pain), HERPES ZOSTER (Shingles), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), ARTHRALGIA (Painful hips) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, BACK PAIN (Low back pain), HERPES ZOSTER (Shingles), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), ARTHRALGIA (Painful hips) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant drugs not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the events of of vaccination site pain, painful hips, drug effect incomplete, shingles and low back pain was not provided with Humira (adalimumab).  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling in arm after COVID-19 booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling in arm after COVID-19 booster shot) 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 ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-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) Citrate free, UNK. In February 2022, the patient experienced VACCINATION SITE SWELLING (Swelling in arm after COVID-19 booster shot). In February 2022, VACCINATION SITE SWELLING (Swelling in arm after COVID-19 booster shot) had resolved.            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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Feeling bad; Tiredness; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), FATIGUE (Tiredness) and PYREXIA (Feverish) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad), FATIGUE (Tiredness) and PYREXIA (Feverish). At the time of the report, FEELING ABNORMAL (Feeling bad), FATIGUE (Tiredness) and PYREXIA (Feverish) had resolved.        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.  No concomitant medication reported. No treatment medication reported.  It was unknown if patient was enrolled in the COVID-19 Vaccine trail.  Primary reporter contact for lot number information was unsuccessful.  The reporter causality for the events feeling bad, tired and feverish with the co-suspect of Humira was reported as no reasonable possibility.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Fatigue, Interchange of vaccine products, Pain, Pain in extremity
Clinical narrative: Skin plaque/Plaques flare up on shins/head/buttocks/elbows and arms; Ache; Fatigue; Pain in arm/Sore arm; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Skin plaque/Plaques flare up on shins/head/buttocks/elbows and arms), PAIN (Ache), FATIGUE (Fatigue), PAIN IN EXTREMITY (Pain in arm/Sore arm) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) 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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 20-Jun-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN PLAQUE (Skin plaque/Plaques flare up on shins/head/buttocks/elbows and arms), PAIN (Ache), FATIGUE (Fatigue), PAIN IN EXTREMITY (Pain in arm/Sore arm), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, SKIN PLAQUE (Skin plaque/Plaques flare up on shins/head/buttocks/elbows and arms) had not resolved and PAIN (Ache), FATIGUE (Fatigue), PAIN IN EXTREMITY (Pain in arm/Sore arm), 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.  No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of plaques flare up on shins/head/buttocks/elbows and arms with  SKYRIZI(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the events of fatigued, sore arm and ACHY with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin plaque
Clinical narrative: Skin plaque/Plaques flare up on shins/head/buttocks/elbows and arms; Ache; Fatigue; Pain in arm/Sore arm; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Skin plaque/Plaques flare up on shins/head/buttocks/elbows and arms), PAIN (Ache), FATIGUE (Fatigue), PAIN IN EXTREMITY (Pain in arm/Sore arm) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) 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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 20-Jun-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN PLAQUE (Skin plaque/Plaques flare up on shins/head/buttocks/elbows and arms), PAIN (Ache), FATIGUE (Fatigue), PAIN IN EXTREMITY (Pain in arm/Sore arm), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, SKIN PLAQUE (Skin plaque/Plaques flare up on shins/head/buttocks/elbows and arms) had not resolved and PAIN (Ache), FATIGUE (Fatigue), PAIN IN EXTREMITY (Pain in arm/Sore arm), 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.  No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of plaques flare up on shins/head/buttocks/elbows and arms with  SKYRIZI(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the events of fatigued, sore arm and ACHY with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: PAIN ON INJECTION SITE/ Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (PAIN ON INJECTION SITE/ Injection site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LEUPRORELIN ACETATE (LUPRON DEPOT) for an unknown indication.    No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LEUPRORELIN ACETATE (LUPRON DEPOT) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (PAIN ON INJECTION SITE/ Injection site pain). At the time of the report, VACCINATION SITE PAIN (PAIN ON INJECTION SITE/ Injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  On 23-Jul-2021, Patient received 1st dose of Moderna COVID-19 Vaccine.  On an unknown date, the patient experienced Pain on injection site.  Treatment information was not provided.  It was unknown if he was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of Pain on injection site with LUPRON DEPOT(LEUPROLIDE ACETATE DEPOT) 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.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Arthralgia, Sinusitis
Clinical narrative: Shoulder pain; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) and SINUSITIS (Sinus infection) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On an unknown date, the patient received first 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., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder pain) and SINUSITIS (Sinus infection). At the time of the report, ARTHRALGIA (Shoulder pain) and SINUSITIS (Sinus infection) was resolving.            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 arthralgia and sinusitis was no reasonable possibility 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.
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus infection
Clinical narrative: Coronavirus infection; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS INFECTION (Coronavirus infection) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) 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 IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient experienced CORONAVIRUS INFECTION (Coronavirus infection). At the time of the report, CORONAVIRUS INFECTION (Coronavirus infection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  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 concerns an adult male patient with use of Ibrutinib for an unknown indication,  who experienced the unexpected, non-serious  adverse event of special interest Coronavirus Infection on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of event onset were not provided. Coronavirus test and treatment were not reported. No information on any other doses of COVID-19 vaccination was provided. Ibrutinib is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to coronavirus infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with use of Ibrutinib for an unknown indication,  who experienced the unexpected, non-serious  adverse event of special interest Coronavirus Infection on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of event onset were not provided. Coronavirus test and treatment were not reported. No information on any other doses of COVID-19 vaccination was provided. Ibrutinib is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to coronavirus infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Peripheral coldness, Peripheral swelling, SARS-CoV-2 test, Vaccination site movement impairment
Clinical narrative: had negative reaction to first moderna covid vaccination was cold shoulder; had negative reaction to first moderna covid vaccination was swelling from  shoulder to fingers of arm; had negative reaction to first Moderna covid vaccination was inability to move the fingers on the arm of the injection; Cough; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough), PERIPHERAL COLDNESS (had negative reaction to first moderna covid vaccination was cold shoulder), PERIPHERAL SWELLING (had negative reaction to first moderna covid vaccination was swelling from  shoulder to fingers of arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (had negative reaction to first Moderna covid vaccination was inability to move the fingers on the arm of the injection) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In February 2022, the patient experienced COUGH (Cough). On an unknown date, the patient experienced PERIPHERAL COLDNESS (had negative reaction to first moderna covid vaccination was cold shoulder), PERIPHERAL SWELLING (had negative reaction to first moderna covid vaccination was swelling from  shoulder to fingers of arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (had negative reaction to first Moderna covid vaccination was inability to move the fingers on the arm of the injection). In February 2022, COUGH (Cough) had resolved. At the time of the report, PERIPHERAL COLDNESS (had negative reaction to first moderna covid vaccination was cold shoulder), PERIPHERAL SWELLING (had negative reaction to first moderna covid vaccination was swelling from  shoulder to fingers of arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (had negative reaction to first Moderna covid vaccination was inability to move the fingers on the arm of the injection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Pain aggravated; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain aggravated) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On 02-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 20-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In April 2021, the patient experienced PAIN (Pain aggravated). In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN (Pain aggravated) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  The patient had flare up of all over body pain when she did not her Rinvoq in Apr 2021. She had sore arm from Moderna vaccines. 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In August 2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) 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.   This case was linked to MOD-2022-621185 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Raynaud's syndrome; This spontaneous case was reported by a consumer and describes the occurrence of RAYNAUD'S PHENOMENON (Raynaud's syndrome) 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 (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   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 ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced RAYNAUD'S PHENOMENON (Raynaud's syndrome). At the time of the report, RAYNAUD'S PHENOMENON (Raynaud's syndrome) outcome was unknown.            Concomitant product use was not provided by the reporter.  On an unknown date, the patient had Raynaud syndrome. No treatment information was provided. The reporter's causality for the event(s) of Raynaud syndrome 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.      Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: FELT ACHY and TIRED; FELT ACHY and TIRED; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (FELT ACHY and TIRED) and FATIGUE (FELT ACHY and TIRED) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 16-Nov-2021, the patient experienced PAIN (FELT ACHY and TIRED) and FATIGUE (FELT ACHY and TIRED). At the time of the report, PAIN (FELT ACHY and TIRED) and FATIGUE (FELT ACHY and TIRED) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621174 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever; KNEES AND JOINT HURT; NOSE WITH STOPPED UP; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (KNEES AND JOINT HURT), NASAL CONGESTION (NOSE WITH STOPPED UP) and OROPHARYNGEAL PAIN (Sore throat) 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, Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis, Ankylosing spondylitis and Rheumatoid arthritis.   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 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) unknown. On an unknown date, the patient experienced PYREXIA (Fever), ARTHRALGIA (KNEES AND JOINT HURT), NASAL CONGESTION (NOSE WITH STOPPED UP) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PYREXIA (Fever), NASAL CONGESTION (NOSE WITH STOPPED UP) and OROPHARYNGEAL PAIN (Sore throat) had resolved and ARTHRALGIA (KNEES AND JOINT HURT) outcome was unknown.            No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SORE THROAT, FEVER, AND NOSE WITH STOPPED UP WITH AFTER TAKING COVID VACCINE unknown onset, SORE THROAT, FEVER, AND NOSE WITH STOPPED UP WITH AFTER TAKING COVID VACCINE unknown onset, SORE THROAT, FEVER, AND NOSE WITH STOPPED UP WITH AFTER TAKING COVID VACCINE unknown onset and KNEES AND JOINT HURT with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment details 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Blood in stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-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. On an unknown date, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Blood in stool) had not resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the event of Blood in stool was assessed as reasonable possibility for cosuspect humira. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment- This spontaneous case concerns a male patient aged 58 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Haematochezia on unknown dates in the context of mRNA-1273 vaccine. Patient had received initial two doses of mRNA-1273 at an interval of 29 days and third dose 10 months later. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 58 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Haematochezia on unknown dates in the context of mRNA-1273 vaccine. Patient had received initial two doses of mRNA-1273 at an interval of 29 days and third dose 10 months later. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Weight increased
Clinical narrative: Low grade fever; Weight gain; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT INCREASED (Weight gain) and PYREXIA (Low grade fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    No Medical History information was reported.   In 2004, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) 125 mcg (125 mcg,1 in 1 D). In 2005, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 112 mcg (112 mcg,1 in 1 D). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 88 mcg for three days and 100 mcg for four days (88 mcg,1 in 1 D). In January 2022, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 100 mcg (100 mcg,1 in 1 D). In February 2021, the patient experienced PYREXIA (Low grade fever). In 2021, the patient experienced WEIGHT INCREASED (Weight gain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In February 2021, PYREXIA (Low grade fever) had resolved. At the time of the report, WEIGHT INCREASED (Weight gain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The reporter's causality for the event of weight gain with Synthroid (levothyroxine) was a reasonable possibility. The reporter's causality for the event of low grade fever with Synthroid (levothyroxine) 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.   This case was linked to MOD-2022-630557, MOD-2022-630556 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICK) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (SICK). At the time of the report, ILLNESS (SICK) 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.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Drug hypersensitivity, Magnetic resonance imaging, Oral pruritus, Throat irritation
Clinical narrative: Progression in hand got worse; Scratchy throat; Itching in mouth roof; Allergic reaction to Rituxan with hives; Allergic reaction to Rituxan with hives; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Progression in hand got worse), THROAT IRRITATION (Scratchy throat), ORAL PRURITUS (Itching in mouth roof), DRUG HYPERSENSITIVITY (Allergic reaction to Rituxan with hives) and URTICARIA (Allergic reaction to Rituxan with hives) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and RITUXIMAB (RITUXAN) for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form and RITUXIMAB (RITUXAN) (Oral) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Progression in hand got worse), THROAT IRRITATION (Scratchy throat), ORAL PRURITUS (Itching in mouth roof), DRUG HYPERSENSITIVITY (Allergic reaction to Rituxan with hives) and URTICARIA (Allergic reaction to Rituxan with hives). At the time of the report, CONDITION AGGRAVATED (Progression in hand got worse), THROAT IRRITATION (Scratchy throat), ORAL PRURITUS (Itching in mouth roof), DRUG HYPERSENSITIVITY (Allergic reaction to Rituxan with hives) and URTICARIA (Allergic reaction to Rituxan with hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Progression in hand had got worse.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of progression in hand got worse, scratchy throat, itching in mouth roof, allergic reaction to Rituxan with hives with Humira (adalimumab) was a reasonable possibility.  The reporter's causality for the events of progression in hand got worse, scratchy throat, itching in mouth roof, allergic reaction to Rituxan with hives with Rituxan was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Progression in hand got worse; Scratchy throat; Itching in mouth roof; Allergic reaction to Rituxan with hives; Allergic reaction to Rituxan with hives; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Progression in hand got worse), THROAT IRRITATION (Scratchy throat), ORAL PRURITUS (Itching in mouth roof), DRUG HYPERSENSITIVITY (Allergic reaction to Rituxan with hives) and URTICARIA (Allergic reaction to Rituxan with hives) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and RITUXIMAB (RITUXAN) for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form and RITUXIMAB (RITUXAN) (Oral) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Progression in hand got worse), THROAT IRRITATION (Scratchy throat), ORAL PRURITUS (Itching in mouth roof), DRUG HYPERSENSITIVITY (Allergic reaction to Rituxan with hives) and URTICARIA (Allergic reaction to Rituxan with hives). At the time of the report, CONDITION AGGRAVATED (Progression in hand got worse), THROAT IRRITATION (Scratchy throat), ORAL PRURITUS (Itching in mouth roof), DRUG HYPERSENSITIVITY (Allergic reaction to Rituxan with hives) and URTICARIA (Allergic reaction to Rituxan with hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Progression in hand had got worse.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of progression in hand got worse, scratchy throat, itching in mouth roof, allergic reaction to Rituxan with hives with Humira (adalimumab) was a reasonable possibility.  The reporter's causality for the events of progression in hand got worse, scratchy throat, itching in mouth roof, allergic reaction to Rituxan with hives with Rituxan was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen Citrate free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  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 concerns adult female patient of unspecified age, with concurrent condition of Plaque psoriasis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to first dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positives on unspecified day. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The concurrent condition of Plaque psoriasis treated with ADALIMUMAB (HUMIRA) could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns adult female patient of unspecified age, with concurrent condition of Plaque psoriasis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to first dose of mRNA-1273 vaccine. SARS-CoV-2 test was Positives on unspecified day. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The concurrent condition of Plaque psoriasis treated with ADALIMUMAB (HUMIRA) could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.