chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood cholesterol, Fatigue, Injection site reaction
Clinical narrative: Knee arthritis; Injection site swelling; Knee pain; Fatigue; Fever; Injection site reaction; Knee injury; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), JOINT INJURY (Knee injury), ARTHRITIS (Knee arthritis), INJECTION SITE SWELLING (Injection site swelling) and ARTHRALGIA (Knee pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    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) Solution for injection in pre-filled pen,. In 2016, the patient experienced JOINT INJURY (Knee injury). On an unknown date, the patient experienced INJECTION SITE REACTION (Injection site reaction), ARTHRITIS (Knee arthritis), INJECTION SITE SWELLING (Injection site swelling), ARTHRALGIA (Knee pain), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, INJECTION SITE REACTION (Injection site reaction), ARTHRALGIA (Knee pain), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved, JOINT INJURY (Knee injury) and ARTHRITIS (Knee arthritis) outcome was unknown and INJECTION SITE SWELLING (Injection site swelling) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: Elevated..         On unknown dates, the patient experienced fatigue, left knee arthritis, elevated cholesterol, fever, swelling at injection site and knee pain. In 2016, the patient experienced banging knee  with the door. on unknown dates, fatigue, fever and knee pain resolved. 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: significant FU: updated events On 02-Mar-2022: Significant follow up appended: updated patient details, dose details and causality.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Joint injury, Pyrexia
Clinical narrative: Knee arthritis; Injection site swelling; Knee pain; Fatigue; Fever; Injection site reaction; Knee injury; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), JOINT INJURY (Knee injury), ARTHRITIS (Knee arthritis), INJECTION SITE SWELLING (Injection site swelling) and ARTHRALGIA (Knee pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    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) Solution for injection in pre-filled pen,. In 2016, the patient experienced JOINT INJURY (Knee injury). On an unknown date, the patient experienced INJECTION SITE REACTION (Injection site reaction), ARTHRITIS (Knee arthritis), INJECTION SITE SWELLING (Injection site swelling), ARTHRALGIA (Knee pain), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, INJECTION SITE REACTION (Injection site reaction), ARTHRALGIA (Knee pain), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved, JOINT INJURY (Knee injury) and ARTHRITIS (Knee arthritis) outcome was unknown and INJECTION SITE SWELLING (Injection site swelling) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: Elevated..         On unknown dates, the patient experienced fatigue, left knee arthritis, elevated cholesterol, fever, swelling at injection site and knee pain. In 2016, the patient experienced banging knee  with the door. on unknown dates, fatigue, fever and knee pain resolved. 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: significant FU: updated events On 02-Mar-2022: Significant follow up appended: updated patient details, dose details and causality.
Age: 84.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crepitations, Ear pain, Herpes zoster, Hyperkeratosis, Muscle injury
Clinical narrative: Crepitations; Shingles; Foot callus; Ear pain; Neck pain; Neck injury; Pain; Muscle injury; Foot pain; Localized muscle pain; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain) and NECK PAIN (Neck pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for 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 CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain), NECK PAIN (Neck pain), NECK INJURY (Neck injury), PAIN (Pain), MUSCLE INJURY (Muscle injury), PAIN IN EXTREMITY (Foot pain), MYALGIA (Localized muscle pain) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain), NECK PAIN (Neck pain), NECK INJURY (Neck injury), PAIN (Pain), MUSCLE INJURY (Muscle injury), PAIN IN EXTREMITY (Foot pain), MYALGIA (Localized muscle pain) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown date, the patient experienced shoulder muscle pain/hurt shoulder muscle while pulling herself up/left side popped, foot pain, shingles, callus on the bottom left foot, covid-19 vaccinations caused soreness at the injection sites, ear pain from waiting hearing aids, pain/hurt neck while pulling herself up and therapy made patient sore. 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: 84.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Neck injury, Neck pain, Pain, Pain in extremity
Clinical narrative: Crepitations; Shingles; Foot callus; Ear pain; Neck pain; Neck injury; Pain; Muscle injury; Foot pain; Localized muscle pain; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain) and NECK PAIN (Neck pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for 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 CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain), NECK PAIN (Neck pain), NECK INJURY (Neck injury), PAIN (Pain), MUSCLE INJURY (Muscle injury), PAIN IN EXTREMITY (Foot pain), MYALGIA (Localized muscle pain) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain), NECK PAIN (Neck pain), NECK INJURY (Neck injury), PAIN (Pain), MUSCLE INJURY (Muscle injury), PAIN IN EXTREMITY (Foot pain), MYALGIA (Localized muscle pain) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown date, the patient experienced shoulder muscle pain/hurt shoulder muscle while pulling herself up/left side popped, foot pain, shingles, callus on the bottom left foot, covid-19 vaccinations caused soreness at the injection sites, ear pain from waiting hearing aids, pain/hurt neck while pulling herself up and therapy made patient sore. 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: 84.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Crepitations; Shingles; Foot callus; Ear pain; Neck pain; Neck injury; Pain; Muscle injury; Foot pain; Localized muscle pain; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain) and NECK PAIN (Neck pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for 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 CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain), NECK PAIN (Neck pain), NECK INJURY (Neck injury), PAIN (Pain), MUSCLE INJURY (Muscle injury), PAIN IN EXTREMITY (Foot pain), MYALGIA (Localized muscle pain) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, CREPITATIONS (Crepitations), HERPES ZOSTER (Shingles), HYPERKERATOSIS (Foot callus), EAR PAIN (Ear pain), NECK PAIN (Neck pain), NECK INJURY (Neck injury), PAIN (Pain), MUSCLE INJURY (Muscle injury), PAIN IN EXTREMITY (Foot pain), MYALGIA (Localized muscle pain) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown date, the patient experienced shoulder muscle pain/hurt shoulder muscle while pulling herself up/left side popped, foot pain, shingles, callus on the bottom left foot, covid-19 vaccinations caused soreness at the injection sites, ear pain from waiting hearing aids, pain/hurt neck while pulling herself up and therapy made patient sore. 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: U
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: very cold feet; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (very cold feet) 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.   In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (very cold feet). At the time of the report, PERIPHERAL COLDNESS (very cold feet) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inflammation, Pain, Somnolence
Clinical narrative: INFLAMMATION; PAIN; PATIENT JUST WANTED TO SLEEP; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (PATIENT JUST WANTED TO SLEEP), INFLAMMATION (INFLAMMATION) and PAIN (PAIN) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SOMNOLENCE (PATIENT JUST WANTED TO SLEEP). On an unknown date, the patient experienced INFLAMMATION (INFLAMMATION) and PAIN (PAIN). At the time of the report, SOMNOLENCE (PATIENT JUST WANTED TO SLEEP) outcome was unknown and INFLAMMATION (INFLAMMATION) and PAIN (PAIN) had not resolved.            No concomitant products were reported.  On unknown dates, the patient experienced inflammation and pain. In 2021, the patient experienced patient just wanted to sleep. moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. on 03-Feb-2021, she received 1st dose covid-19 vaccine manufactured by moderna. on 03-Mar-2021, she received 2nd dose covid-19 vaccine manufactured by moderna. In 2021, she received moderna booster.  Causality for humira (adalimumab) the reporter's causality for the event(s) of patient just wanted to sleep and inflammation was not provided. The reporter's causality for the event(s) of pain with humira(adalimumab) was a reasonable possibility.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Colitis ulcerative, Influenza like illness, Pyrexia
Clinical narrative: Ulcerative colitis; Bowel discomfort; Flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis), ABDOMINAL DISCOMFORT (Bowel discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis), ABDOMINAL DISCOMFORT (Bowel discomfort), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis) had not resolved, ABDOMINAL DISCOMFORT (Bowel discomfort) was resolving and INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the event of Bowel discomfort was assessed as reasonable possibility for cosuspect humira. The  reporter causality for the events of flu like symptoms,fever,ulcerative colitis was assessed as "Not reported" cosuspect humira. The Humira drug was available as Solution for injection in pre-filled syringe. 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: I need to know if I can take the booster when I was allergic to Moderna; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (I need to know if I can take the booster when I was allergic to Moderna) 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 18-Nov-2021, the patient experienced ALLERGY TO VACCINE (I need to know if I can take the booster when I was allergic to Moderna). At the time of the report, ALLERGY TO VACCINE (I need to know if I can take the booster when I was allergic to Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    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 and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            No concomitant products were reported.  On an unknown date, the patient experienced fatigued. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On unknown date, patient received covid-19 booster vaccine manufactured by moderna.  Causality for humira (adalimumab) The reporter's causality for the event(s) of fatigued with humira(adalimumab) was no reasonable possibility.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fall, Fatigue, Hormone level abnormal, Muscular weakness, Pyrexia
Clinical narrative: Hormonal imbalance; Localised muscle weakness (Weak in knees and ankles); Fatigue; Fever; Fall; This spontaneous case was reported by a consumer and describes the occurrence of HORMONE LEVEL ABNORMAL (Hormonal imbalance), FALL (Fall), MUSCULAR WEAKNESS (Localised muscle weakness (Weak in knees and ankles)), FATIGUE (Fatigue) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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) 1 dosage form. In 2021, the patient experienced FALL (Fall), FATIGUE (Fatigue) and PYREXIA (Fever). On an unknown date, the patient experienced HORMONE LEVEL ABNORMAL (Hormonal imbalance) and MUSCULAR WEAKNESS (Localised muscle weakness (Weak in knees and ankles)). In 2021, FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. At the time of the report, HORMONE LEVEL ABNORMAL (Hormonal imbalance), FALL (Fall) and MUSCULAR WEAKNESS (Localised muscle weakness (Weak in knees and ankles)) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of FELL DUE TO HORMONAL IMBALANCE MADE WEAK IN KNEES AND ANKLES unknown onset, FELL DUE TO HORMONAL IMBALANCE MADE WEAK IN KNEES AND ANKLES onset in 2021 and FELL DUE TO HORMONAL IMBALANCE MADE WEAK IN KNEES AND ANKLES unknown onset was not provided. The reporter's causality for the event(s) of FATIGUE WITH SECOND COVID VACCINE and FEVER WITH SECOND COVID VACCINE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Malaise, Weight
Clinical narrative: felt sick; LEFT KNEE SORENESS; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick) and ARTHRALGIA (LEFT KNEE SORENESS) 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 ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   In January 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. 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 17-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In February 2021, the patient experienced MALAISE (felt sick). In 2021, the patient experienced ARTHRALGIA (LEFT KNEE SORENESS). At the time of the report, MALAISE (felt sick) outcome was unknown and ARTHRALGIA (LEFT KNEE SORENESS) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: Lost Over 100 pounds.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.   On 01 Feb 2021, the patient received 1st dose covid 19 vaccine manufactured by Moderna and She felt sick after getting first covid vaccine. On 26 Feb 2021, she had a break of 20 days of Humira due to bariatric surgery on 01 Mar 2021 and discharged from hospital on 03 Mar 2021 and she lost over 100 pounds weight. It was unknown if she was enrolled in a covid 19 vaccine trial.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-621013 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.            No concomitant medications were reported. It was repoetd that patient had a similar experience, but caller's dizziness was for a minute. 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, UNK
Symptoms: Malaise, Nasopharyngitis, Sinusitis, Vaccination site bruising
Clinical narrative: Felt ill after covid vaccination; Cold; Sinus infection; Bruises after injection; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill after covid vaccination), NASOPHARYNGITIS (Cold), SINUSITIS (Sinus infection) and VACCINATION SITE BRUISING (Bruises after injection) 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).   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Felt ill after covid vaccination), NASOPHARYNGITIS (Cold), SINUSITIS (Sinus infection) and VACCINATION SITE BRUISING (Bruises after injection). At the time of the report, MALAISE (Felt ill after covid vaccination) outcome was unknown and NASOPHARYNGITIS (Cold), SINUSITIS (Sinus infection) and VACCINATION SITE BRUISING (Bruises after injection) was resolving.            No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality for the event(s) of felt ill after COVID vaccination was not provided. The reporter's causality for the event(s) of cold, sinus infection and bruises after injection with HUMIRA(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Sensitivity to weather change, Vaccination site pain
Clinical narrative: SORENESS; SWELLING IN HANDS AND FEET; Rainy weather influencing soreness; INJECTION SITE SORENESS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (SORENESS), PERIPHERAL SWELLING (SWELLING IN HANDS AND FEET), SENSITIVITY TO WEATHER CHANGE (Rainy weather influencing soreness) and VACCINATION SITE PAIN (INJECTION SITE SORENESS) in a 60-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.    The patient's past medical history included Spinal operation in 2021. Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (SORENESS), PERIPHERAL SWELLING (SWELLING IN HANDS AND FEET), SENSITIVITY TO WEATHER CHANGE (Rainy weather influencing soreness) and VACCINATION SITE PAIN (INJECTION SITE SORENESS). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN (SORENESS), PERIPHERAL SWELLING (SWELLING IN HANDS AND FEET) and VACCINATION SITE PAIN (INJECTION SITE SORENESS) was resolving and SENSITIVITY TO WEATHER CHANGE (Rainy weather influencing soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  It was reported that patient was feeling great improvement in her hands and feet. In 2021, she had procedure completed on the cervical vertebrae.  The reporters causality for the event(s) of CERVICAL ABLATION/PROCEDURE ON THE CERVICAL VERTEBRAE, SORENESS and INJECTION SITE SORENESS WITH COVID VACCINE with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of SWELLING IN HANDS AND FEET with RINVOQ(UPADACITINIB) 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
Symptoms: COVID-19 immunisation, Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered; Revaccination with different COVID-19 vaccine; interchange of vaccine products; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 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) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and 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.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fall, Fatigue, Hormone level abnormal, Muscular weakness, Pyrexia
Clinical narrative: Hormonal imbalance; Fatigue; Localised muscle weakness; Fever; Fall; This spontaneous case was reported by a consumer and describes the occurrence of HORMONE LEVEL ABNORMAL (Hormonal imbalance), FATIGUE (Fatigue), MUSCULAR WEAKNESS (Localised muscle weakness), PYREXIA (Fever) and FALL (Fall) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced FATIGUE (Fatigue), MUSCULAR WEAKNESS (Localised muscle weakness), PYREXIA (Fever) and FALL (Fall). On an unknown date, the patient experienced HORMONE LEVEL ABNORMAL (Hormonal imbalance). In 2021, FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. At the time of the report, HORMONE LEVEL ABNORMAL (Hormonal imbalance), MUSCULAR WEAKNESS (Localised muscle weakness) and FALL (Fall) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the event of fatigue, fever was assessed as "No reasonable possibility" for cosuspect humira. The reporter causality for the event of of Hormonal imbalance, Localised muscle weakness,fall was assessed as "Not reported" for cosuspect humira. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 40.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; JOINT PAIN; NOT FEELING REGULAR; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (NOT FEELING REGULAR), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ARTHRALGIA (JOINT PAIN) in a 40-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 Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-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 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, the patient experienced FEELING ABNORMAL (NOT FEELING REGULAR) and ARTHRALGIA (JOINT PAIN). At the time of the report, FEELING ABNORMAL (NOT FEELING REGULAR) had resolved, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and ARTHRALGIA (JOINT PAIN) had not resolved.            Concomitant medication was not reported. Treatment details were unknown.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Fatigue; Stiffness; Arthralgia; Hand pain; Headache; Joint pain; Myalgia upper extremities; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Arthralgia), PAIN IN EXTREMITY (Hand pain) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 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 FATIGUE (Fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Arthralgia), PAIN IN EXTREMITY (Hand pain), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Myalgia upper extremities). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Myalgia upper extremities) had resolved and MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Arthralgia) and PAIN IN EXTREMITY (Hand pain) had not resolved.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Fatigue; Stiffness; Arthralgia; Hand pain; Headache; Joint pain; Myalgia upper extremities; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Arthralgia), PAIN IN EXTREMITY (Hand pain) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 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 FATIGUE (Fatigue), MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Arthralgia), PAIN IN EXTREMITY (Hand pain), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Myalgia upper extremities). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Myalgia upper extremities) had resolved and MUSCULOSKELETAL STIFFNESS (Stiffness), ARTHRALGIA (Arthralgia) and PAIN IN EXTREMITY (Hand pain) had not resolved.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I received Moderna vaccine on March 11th and my life has not been the same since; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I received Moderna vaccine on March 11th and my life has not been the same since) 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 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced IMMUNISATION REACTION (I received Moderna vaccine on March 11th and my life has not been the same since). At the time of the report, IMMUNISATION REACTION (I received Moderna vaccine on March 11th and my life has not been the same since) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Since received Moderna vaccine, patient's life was not been same. Treatment details were not reported.  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, FLUX
Symptoms: Tooth extraction, Vaccination site pain
Clinical narrative: FEW TEETH PULLED; ARM WAS SORE; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH EXTRACTION (FEW TEETH PULLED) and VACCINATION SITE PAIN (ARM WAS SORE) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and INFLUENZA VACCINE for Vaccination.    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, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH EXTRACTION (FEW TEETH PULLED) and VACCINATION SITE PAIN (ARM WAS SORE). At the time of the report, TOOTH EXTRACTION (FEW TEETH PULLED) and VACCINATION SITE PAIN (ARM WAS SORE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Feeling abnormal, Sinusitis
Clinical narrative: Crohn's disease aggravated; Sinus infection; After second covid-19 vaccine felt pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FEELING ABNORMAL (After second covid-19 vaccine felt pretty bad). In October 2021, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criterion medically significant) and SINUSITIS (Sinus infection). In 2021, CROHN'S DISEASE (Crohn's disease aggravated), FEELING ABNORMAL (After second covid-19 vaccine felt pretty bad) and SINUSITIS (Sinus infection) had resolved.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 26-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease. The patient experienced flare up of Crohn's disease approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved within the same year. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 26-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease. The patient experienced flare up of Crohn's disease approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved within the same year. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Gingival bleeding, Interchange of vaccine products
Clinical narrative: While brushing teeth, his teeth tasted blood; Patient had Comirnaty and Moderna vaccine (second shot); Patient had Comirnaty and Moderna vaccine (second shot); This spontaneous case was reported by a patient family member or friend and describes the occurrence of GINGIVAL BLEEDING (While brushing teeth, his teeth tasted blood), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine (second shot)) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine (second shot)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVAL BLEEDING (While brushing teeth, his teeth tasted blood), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine (second shot)) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine (second shot)). At the time of the report, GINGIVAL BLEEDING (While brushing teeth, his teeth tasted blood), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine (second shot)) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine (second shot)) outcome was unknown.            No treatment and concomitant information was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact