chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Vaccination site pain
Clinical narrative: pain in my left arm where paramedic made the injection; temperature went up at 14.00 PM until 38,1 C, early this afternoon; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in my left arm where paramedic made the injection) and BODY TEMPERATURE INCREASED (temperature went up at 14.00 PM until 38,1 C, early this afternoon) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in my left arm where paramedic made the injection) and BODY TEMPERATURE INCREASED (temperature went up at 14.00 PM until 38,1 C, early this afternoon). At the time of the report, VACCINATION SITE PAIN (pain in my left arm where paramedic made the injection) and BODY TEMPERATURE INCREASED (temperature went up at 14.00 PM until 38,1 C, early this afternoon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment Drug was provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Intervertebral disc disorder, Nerve compression, Pain
Clinical narrative: Pinched nerve in back; Disc issue in back; Achy and fatigue following second COVID vaccine; Achy and fatigue following second COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy and fatigue following second COVID vaccine), NERVE COMPRESSION (Pinched nerve in back), INTERVERTEBRAL DISC DISORDER (Disc issue in back) and FATIGUE (Achy and fatigue following second COVID vaccine) in a 56-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.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Achy and fatigue following second COVID vaccine) and FATIGUE (Achy and fatigue following second COVID vaccine). On an unknown date, the patient experienced NERVE COMPRESSION (Pinched nerve in back) and INTERVERTEBRAL DISC DISORDER (Disc issue in back). At the time of the report, PAIN (Achy and fatigue following second COVID vaccine), NERVE COMPRESSION (Pinched nerve in back), INTERVERTEBRAL DISC DISORDER (Disc issue in back) and FATIGUE (Achy and fatigue following second COVID vaccine) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  On unknown dates, the patient experienced pinched nerve in back and disc issue in back. In 2021, the patient experienced achy and fatigue following second COVID vaccine.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of pinched nerve in back, disc issue in back, achy and fatigue following second COVID vaccine was not provided for co-suspect RINVOQ.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity, Psoriasis
Clinical narrative: Feels bad, felt bad; Plaque psoriasis aroung belt buckle; Pain in arm, arm sore; Tiredness, felt run down/tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feels bad, felt bad), PSORIASIS (Plaque psoriasis aroung belt buckle), PAIN IN EXTREMITY (Pain in arm, arm sore) and FATIGUE (Tiredness, felt run down/tired) 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 Plaque psoriasis.    No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-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) Citrate free. On an unknown date, the patient experienced FEELING ABNORMAL (Feels bad, felt bad), PSORIASIS (Plaque psoriasis aroung belt buckle), PAIN IN EXTREMITY (Pain in arm, arm sore) and FATIGUE (Tiredness, felt run down/tired). At the time of the report, FEELING ABNORMAL (Feels bad, felt bad), PAIN IN EXTREMITY (Pain in arm, arm sore) and FATIGUE (Tiredness, felt run down/tired) had resolved and PSORIASIS (Plaque psoriasis aroung belt buckle) was resolving.            No concomitant medications were reported. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624769 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Platelet count, Platelet count decreased, Renal disorder
Clinical narrative: Kidney issues; Lowplatelet count; Tired; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Kidney issues), PLATELET COUNT DECREASED (Lowplatelet count) and FATIGUE (Tired) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication.    No Medical History information was reported.   On 01-Sep-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-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 experienced RENAL DISORDER (Kidney issues), PLATELET COUNT DECREASED (Lowplatelet count) and FATIGUE (Tired). At the time of the report, RENAL DISORDER (Kidney issues) outcome was unknown and PLATELET COUNT DECREASED (Lowplatelet count) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: Low.         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: 46.0
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 a 46-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 an unknown indication.    There was no reported medical history.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624687 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Renal impairment
Clinical narrative: Kidney function changes; This spontaneous case was reported by a consumer and describes the occurrence of RENAL IMPAIRMENT (Kidney function changes) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Mantle cell lymphoma.    Concurrent medical conditions included Mantle cell lymphoma.   On 23-Oct-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RENAL IMPAIRMENT (Kidney function changes) (seriousness criterion medically significant). At the time of the report, RENAL IMPAIRMENT (Kidney function changes) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Company comment-This spontaneous case concerns an elderly  male patient of unspecified age with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Renal impairment(AESI) on unknown dates after a dose (dose number not specified) of mRNA-1273 vaccine.. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the events was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.  The reporter's causality for Imbruvica for the event(s) of KIDNEY FUNCTION CHANGES 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.; Sender's Comments: This spontaneous case concerns an elderly  male patient of unspecified age with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Renal impairment(AESI) on unknown dates after a dose (dose number not specified) of mRNA-1273 vaccine.. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the events was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Fatigue
Clinical narrative: Skin dry/SKIN TO BE REALLY DRY; Fatigue/FEEL FATIGUED; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Skin dry/SKIN TO BE REALLY DRY) and FATIGUE (Fatigue/FEEL FATIGUED) in a 55-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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-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) 1 dosage form. In December 2021, the patient experienced FATIGUE (Fatigue/FEEL FATIGUED). On an unknown date, the patient experienced DRY SKIN (Skin dry/SKIN TO BE REALLY DRY). In December 2021, FATIGUE (Fatigue/FEEL FATIGUED) had resolved. At the time of the report, DRY SKIN (Skin dry/SKIN TO BE REALLY DRY) had not resolved. Not Provided          No concomitant medications were reported.  01-DEC-2021: The patient took moderna booster dose. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Injection site pain, Interchange of vaccine products, Psoriasis, Pyrexia
Clinical narrative: Psoriasis getting worse; Pain during injection; Primary series was Pfizer and booster dose was Moderna; Primary series was Pfizer and booster dose was Moderna; After Moderna vaccine, patient ran a fever; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis getting worse), COVID-19 IMMUNISATION (Primary series was Pfizer and booster dose was Moderna), INTERCHANGE OF VACCINE PRODUCTS (Primary series was Pfizer and booster dose was Moderna), PYREXIA (After Moderna vaccine, patient ran a fever) and INJECTION SITE PAIN (Pain during injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Plaque psoriasis: HUMIRA from 02-Jul-2019 to 24-Apr-2020 and HUMIRA from 02-Jul-2019 to 24-Apr-2020. Past adverse reactions to the above products included Drug effect incomplete with HUMIRA; and Pain during injection with HUMIRA. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PYREXIA (After Moderna vaccine, patient ran a fever). On 30-Nov-2021, the patient experienced COVID-19 IMMUNISATION (Primary series was Pfizer and booster dose was Moderna) and INTERCHANGE OF VACCINE PRODUCTS (Primary series was Pfizer and booster dose was Moderna). On an unknown date, the patient experienced PSORIASIS (Psoriasis getting worse) and INJECTION SITE PAIN (Pain during injection). In 2021, PYREXIA (After Moderna vaccine, patient ran a fever) had resolved. At the time of the report, PSORIASIS (Psoriasis getting worse), COVID-19 IMMUNISATION (Primary series was Pfizer and booster dose was Moderna), INTERCHANGE OF VACCINE PRODUCTS (Primary series was Pfizer and booster dose was Moderna) and INJECTION SITE PAIN (Pain during injection) outcome was unknown.            Humira was administered subcutaneously and formulation reported was Solution for injection in pre-filled pen. The reporter's causality for drug effect incomplete, pyrexia was no reasonable possibility and for Pain during injection was reasonable possibility. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Reporter did not have the lot number information, because the packaging was discarded. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Erythema, SARS-CoV-2 test
Clinical narrative: SKIN REDNESS; Lack of drug effect; COVID POSITIVE; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (SKIN REDNESS), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID POSITIVE) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 25-Jan-2022, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID POSITIVE). On an unknown date, the patient experienced ERYTHEMA (SKIN REDNESS). At the time of the report, ERYTHEMA (SKIN REDNESS) had not resolved, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and COVID-19 (COVID POSITIVE) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         NO KNOWN ALLERGIES. No concomitant drugs taken. On an unknown date, the patient experienced SKIN REDNESS. On 25 Jan 2022, the patient experienced COVID POSITIVE.. No treatment medication was reported. Primary reporter did not have the lot number information, because the packaging was discarded.   Causality for SKYRIZI(RISANKIZUMAB):  The reporter's causality for the event(s) of COVID POSITIVE was not provided. The reporter's causality for the event(s) of SKIN REDNESS with SKYRIZI(RISANKIZUMAB) 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: UNK
Symptoms: Drug interaction, Joint swelling, Rash macular
Clinical narrative: HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING; HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING; HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING), JOINT SWELLING (HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING) and RASH MACULAR (HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen. On an unknown date, the patient experienced DRUG INTERACTION (HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING), JOINT SWELLING (HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING) and RASH MACULAR (HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING). At the time of the report, DRUG INTERACTION (HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING) outcome was unknown and JOINT SWELLING (HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING) and RASH MACULAR (HUMIRA HAD BAD INTERACTION TO COVID-19 VACCINE/RED SPOTS ALL OVER LEGS/ANKLES SWELLING) was resolving.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Unspecified disorder of immune mechanism; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Unspecified disorder of immune mechanism) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and Psoriatic arthritis.    The patient had no known allergies.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (Unspecified disorder of immune mechanism). At the time of the report, IMMUNE SYSTEM DISORDER (Unspecified disorder of immune mechanism) outcome was unknown.     it was reported that, the patient experienced negative immune response to booster dose of vaccine.   It was unknown if patient was enrolled in a covid-19 vaccine trial.  No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: hot at administration site-Medium
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Hypertension, Injection site erythema, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: SWELLING RIGHT FOOT, KIDNEY PAIN-Severe, Systemic: Hypertension-Severe, Additional Details: .
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Renal pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: SWELLING RIGHT FOOT, KIDNEY PAIN-Severe, Systemic: Hypertension-Severe, Additional Details: .
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Bell's Palsy-Medium, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Bell's Palsy-Medium, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Menopause, Mood swings, Night sweats
Clinical narrative: Menopause; Hot flashes; Mood swings; Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of MENOPAUSE (Menopause), HOT FLUSH (Hot flashes), MOOD SWINGS (Mood swings) and NIGHT SWEATS (Night sweats) in an elderly male patient who received mRNA-1273 (Spikevax) 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 dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced MENOPAUSE (Menopause), HOT FLUSH (Hot flashes), MOOD SWINGS (Mood swings) and NIGHT SWEATS (Night sweats). At the time of the report, MENOPAUSE (Menopause) had not resolved and HOT FLUSH (Hot flashes), MOOD SWINGS (Mood swings) and NIGHT SWEATS (Night sweats) outcome was unknown.        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 event of MENOPAUSE with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of HOT FLASHES, MOOD SWINGS and NIGHT SWEATS 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Patient feels numb and tingley on the face and lip and travel to arms then leg-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: pt said she feels numbness and tingly on face then migrated to lip. once that goes away it moved to her leg
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a non-health professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 026B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No relevant concomitant medications were reported. Patient had booster dose of Pfizer on 02 Nov 2021 with Lot- F63527. It was stated by the health department that for both the Moderna and Pfizer shots the primary care physician did not keep a log of the storage temperature of the vaccine and was not documented as per CDC requirements and that it is unknown if the vaccines were stored properly for the storage temperature requirements and that these vaccines could be compromised or not as effective. The clinic assured patient that the vaccines were stored properly, but they have no records at all. No treatment medication 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: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Peripheral swelling
Clinical narrative: LEFT LEG SEEMS TO BE GETTING SWOLLEN; 1st dose was administered on 01-Mar-2021 and 2nd dose on 15-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (LEFT LEG SEEMS TO BE GETTING SWOLLEN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 01-Mar-2021 and 2nd dose on 15-Mar-2021) in a 51-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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 01-Mar-2021 and 2nd dose on 15-Mar-2021). On an unknown date, the patient experienced PERIPHERAL SWELLING (LEFT LEG SEEMS TO BE GETTING SWOLLEN). At the time of the report, PERIPHERAL SWELLING (LEFT LEG SEEMS TO BE GETTING SWOLLEN) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 01-Mar-2021 and 2nd dose on 15-Mar-2021) outcome was unknown.            It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  The reporter's causality for the event(s) of LEFT LEG SEEMS TO BE GETTING SWOLLEN with HUMIRA(ADALIMUMAB) was a reasonable possibility.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain, Peripheral swelling, Vaccination site hypoaesthesia
Clinical narrative: Hands were bothering more; More aching shoulders/ache under the knees; Leg swelled up after the first and second vaccine; Aching after the first and second vaccine; Numbness in arms where vaccine was injected; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Hands were bothering more), PERIPHERAL SWELLING (Leg swelled up after the first and second vaccine), PAIN (Aching after the first and second vaccine), VACCINATION SITE HYPOAESTHESIA (Numbness in arms where vaccine was injected) and ARTHRALGIA (More aching shoulders/ache under the knees) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In July 2021, the patient experienced PERIPHERAL SWELLING (Leg swelled up after the first and second vaccine), PAIN (Aching after the first and second vaccine) and VACCINATION SITE HYPOAESTHESIA (Numbness in arms where vaccine was injected). On an unknown date, the patient experienced LIMB DISCOMFORT (Hands were bothering more) and ARTHRALGIA (More aching shoulders/ache under the knees). At the time of the report, LIMB DISCOMFORT (Hands were bothering more) and ARTHRALGIA (More aching shoulders/ache under the knees) had not resolved and PERIPHERAL SWELLING (Leg swelled up after the first and second vaccine), PAIN (Aching after the first and second vaccine) and VACCINATION SITE HYPOAESTHESIA (Numbness in arms where vaccine was injected) outcome 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 numbness in arms where vaccine was injected, more aching shoulders/ ache under the knees, hands were bothering more, leg swelled up and aching after the first and second vaccine was not provided for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Headache, Pain, Vaccination site pain
Clinical narrative: Stomach pain, sharp pain in the right side of stomach; Vaccination site pain, arm hurt after vaccination; Headache; Weakness; Generalized aching, body aches; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness), PAIN (Generalized aching, body aches), ABDOMINAL PAIN UPPER (Stomach pain, sharp pain in the right side of stomach), VACCINATION SITE PAIN (Vaccination site pain, arm hurt after vaccination) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-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. In 2021, the patient experienced ASTHENIA (Weakness), PAIN (Generalized aching, body aches), VACCINATION SITE PAIN (Vaccination site pain, arm hurt after vaccination) and HEADACHE (Headache). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain, sharp pain in the right side of stomach). In 2021, ASTHENIA (Weakness), PAIN (Generalized aching, body aches), VACCINATION SITE PAIN (Vaccination site pain, arm hurt after vaccination) and HEADACHE (Headache) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain, sharp pain in the right side of stomach) had resolved.            No concomitant medications were reported. 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: Fatigue, Skin disorder, Vaccination site pain
Clinical narrative: RING OF BUMPS ON BOTH ELBOWS; PAIN IN ARM AFTER COVID-19 VACCINE; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (RING OF BUMPS ON BOTH ELBOWS), VACCINATION SITE PAIN (PAIN IN ARM AFTER COVID-19 VACCINE) and FATIGUE (FATIGUE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (RING OF BUMPS ON BOTH ELBOWS), VACCINATION SITE PAIN (PAIN IN ARM AFTER COVID-19 VACCINE) and FATIGUE (FATIGUE). At the time of the report, SKIN DISORDER (RING OF BUMPS ON BOTH ELBOWS), VACCINATION SITE PAIN (PAIN IN ARM AFTER COVID-19 VACCINE) and FATIGUE (FATIGUE) 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction
Clinical narrative: PATIENT HAD REACTION AFTER FIRST COVID VACCINE SHOT; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (PATIENT HAD REACTION AFTER FIRST COVID VACCINE SHOT) and FATIGUE (TIRED) 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 Rheumatoid arthritis.    Concurrent medical conditions included 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced IMMUNISATION REACTION (PATIENT HAD REACTION AFTER FIRST COVID VACCINE SHOT) and FATIGUE (TIRED). At the time of the report, IMMUNISATION REACTION (PATIENT HAD REACTION AFTER FIRST COVID VACCINE SHOT) and FATIGUE (TIRED) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No concomitant medication were reported.  On unknown dates, the patient experienced got second booster off humira medication for two weeks before and after (Inappropriate schedule of product discontinuation).  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: Fever, general weakness during night and following day; Fever, general weakness during night and following day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Fever, general weakness during night and following day) and PYREXIA (Fever, general weakness during night and following day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007M20A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Cholesterol. Concurrent medical conditions included Blood pressure high and Seafood allergy (Shrimp). Concomitant products included METOPROLOL and LOSARTAN for an unknown indication.   On 16-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021 at 2:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021 at 7:00 PM, the patient experienced ASTHENIA (Fever, general weakness during night and following day) and PYREXIA (Fever, general weakness during night and following day). At the time of the report, ASTHENIA (Fever, general weakness during night and following day) and PYREXIA (Fever, general weakness during night and following day) had resolved.            The patient haven't received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment medication 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: Condition aggravated, Hidradenitis, Illness
Clinical narrative: SICK AFTER COVID VACCINATION; COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG; COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICK AFTER COVID VACCINATION), HIDRADENITIS (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) and CONDITION AGGRAVATED (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    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) CF, Solution for injection in pre-filled pen. On an unknown date, the patient experienced ILLNESS (SICK AFTER COVID VACCINATION), HIDRADENITIS (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) and CONDITION AGGRAVATED (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG). At the time of the report, ILLNESS (SICK AFTER COVID VACCINATION) had resolved and HIDRADENITIS (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) and CONDITION AGGRAVATED (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of SICK AFTER COVID VACCINATION and COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Weight gain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain) in a 49-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.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 Unknown,1 in 1 D. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 Unknown,1 in 1 D. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain). At the time of the report, WEIGHT INCREASED (Weight gain) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight increased: GAIN 6 LBS.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. The patient reported that she feels Rinvoq had caused her to gain six pounds since Dec 2021. She received COVID-19 booster on 08 Dec 2021 and being off Rinvoq for one-week post vaccination per physician instructions.  Patient felts that Rinvoq was not working for her since she restarted the treatment on 15 Dec 2021, post COVID-19 booster.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No concomitant medications were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: RINGING IN EARS THAT STARTED AFTER GETTING COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (RINGING IN EARS THAT STARTED AFTER GETTING COVID VACCINE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Panuveitis.    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 third 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 TINNITUS (RINGING IN EARS THAT STARTED AFTER GETTING COVID VACCINE). At the time of the report, TINNITUS (RINGING IN EARS THAT STARTED AFTER GETTING COVID VACCINE) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: found nothing wrong.         No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.