chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Vaccination site pain
Clinical narrative: Stiffness joints; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiffness joints) and VACCINATION SITE PAIN (Vaccination site pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia in 2004, Anxiety in 2006, Depression in 2006, Fatigue in 2006, Hearing loss in 2010, Joint pain in 2010, Eye inflammation in 2018, Eye pain in 2018, Dry eyes, Dry mouth, Abstains from alcohol, Tobacco abuse, Epstein Barr virus positive mucocutaneous ulcer, Foot surgery in 1984, Knee surgery NOS in 1988, Ligament operation in 1988, Appendectomy in 1992, Caesarean section in 1998, Surgery in 2014 and Uterine ablation in 2014. Concurrent medical conditions included Psoriasis, Psoriatic arthritis, Pain in ankle, Pain in elbow, Shoulder pain and Pain in extremity.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced JOINT STIFFNESS (Stiffness joints) and VACCINATION SITE PAIN (Vaccination site pain). In March 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. In April 2021, JOINT STIFFNESS (Stiffness joints) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. 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   This case was linked to MOD-2021-112558 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased
Clinical narrative: Chest uncomfortable; increased heart rate; breathing problem; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Chest uncomfortable), HEART RATE INCREASED (increased heart rate) and DYSPNOEA (breathing problem) 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 CHEST DISCOMFORT (Chest uncomfortable), HEART RATE INCREASED (increased heart rate) and DYSPNEA (breathing problem). At the time of the report, CHEST DISCOMFORT (Chest uncomfortable), HEART RATE INCREASED (increased heart rate) and DYSPNOEA (breathing problem) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided. The fresh herbs including mint, basil, Huttuynia, peppermint, bean sprouts, lettuce, and fresh garlic also helped the patient side effects of Moderna vaccine.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia
Clinical narrative: I havent been able to go out for a couple of days; Whole Body is Aching; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I havent been able to go out for a couple of days) and MYALGIA (Whole Body is Aching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    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 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I havent been able to go out for a couple of days) and MYALGIA (Whole Body is Aching). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I havent been able to go out for a couple of days) and MYALGIA (Whole Body is Aching) outcome was unknown.            No relevant concomitant medications were reported. 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: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    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 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) was resolving.            No concomitant medication information was provided. The patient felt tired possibly due to the Covid Vaccine shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Headache
Clinical narrative: Headaches; Blood pressure went up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and BLOOD PRESSURE INCREASED (Blood pressure went up) in a  patient of an unknown age and gender 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 TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headaches) and BLOOD PRESSURE INCREASED (Blood pressure went up). At the time of the report, HEADACHE (Headaches) and BLOOD PRESSURE INCREASED (Blood pressure went up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High Fever) 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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced PYREXIA (High Fever). At the time of the report, PYREXIA (High Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.   This case was linked to MOD-2021-624854 (Patient Link).   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Fatigue, Malaise
Clinical narrative: Felt sick; Chill; Felt tired; Unable to focus; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick), CHILLS (Chill), FATIGUE (Felt tired) and DISTURBANCE IN ATTENTION (Unable to focus) in a 59-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 Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, citrate free. On an unknown date, the patient experienced MALAISE (Felt sick), CHILLS (Chill), FATIGUE (Felt tired) and DISTURBANCE IN ATTENTION (Unable to focus). At the time of the report, MALAISE (Felt sick), CHILLS (Chill), FATIGUE (Felt tired) and DISTURBANCE IN ATTENTION (Unable to focus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and 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: F
Vaccine: COVID19
Symptoms: Breast discharge
Clinical narrative: Breast discharge; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCHARGE (Breast discharge) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (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 and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced BREAST DISCHARGE (Breast discharge). At the time of the report, BREAST DISCHARGE (Breast discharge) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 61-year-old male patient 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 FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient had Moderna vaccine and had complaints of being tired.  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: F
Vaccine: COVID19
Symptoms: Malaise, Psoriasis
Clinical narrative: Ill feeling; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill feeling) and PSORIASIS (Psoriasis flare-up) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concomitant products included CYANOCOBALAMIN (B-12) for an unknown indication.   On 13-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 an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Ill feeling) and PSORIASIS (Psoriasis flare-up). At the time of the report, MALAISE (Ill feeling) outcome was unknown and PSORIASIS (Psoriasis flare-up) had not resolved.            The patient had flare up. She had surface rash at bottom of scalp, She had itches when she was sweating. Her second dose of moderna vaccine caused feeling of being ill.  She was taking supplement of B-12 injections. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis
Clinical narrative: Spondylitis ankylosing aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant). At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) outcome was unknown.            Other concomitant Medication use information was not provided by reporter.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality of humira vaccine for the event(s) of increased ankylosing spondylitis symptoms was not provided.  Treatment Medication use information was not 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.  Company comment: This is a spontaneous case reported by a consumer. A 58-year-old female patient, in treatment with Adalimumab for Ankylosing spondylitis, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of Spondylitis ankylosing aggravated (AESI). Onset date of the event was not provided; hence, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Spondylitis ankylosing can flare as part of its natural history. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 58-year-old female patient, in treatment with Adalimumab for Ankylosing spondylitis, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of Spondylitis ankylosing aggravated. Onset date of the event was not provided; hence, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Spondylitis ankylosing can flare as part of its natural history. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Caused slight redness on her arms; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Caused slight redness on her arms) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for an unknown indication.    The patient's past medical history included Injection (Patient gets an injection for her bones every 3 months). Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 PALBOCICLIB (IBRANCE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (Caused slight redness on her arms). At the time of the report, ERYTHEMA (Caused slight redness on her arms) outcome was unknown.            No concomitant medications were reported.  The first two doses of Moderna vaccine only caused slight redness on her arm but no other reaction. Patient was currently on Ibrance but listed no side effects.  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.   This case was linked to MOD-2021-624969 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   The patient did not think Skyrizi was working as well as he expected. After taking his Covid 19 Vaccines he only felt a sore arm for a couple of days after both injections in Aug 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter did not have the lot number information, because the packaging was discarded.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   The patient stated that Skyrizi has never relieved her condition and when she saw the dermatologist, dermatologist did not think that she had psoriasis. She also had fever after Covid vaccine.  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.
Age: 77.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lymphoedema, Rash macular
Clinical narrative: Accidental Underdose/Patient took booster instead of third dose; Inappropriate schedule of vaccine administartion/patient took booster instaed of third full dose; Lymphedema; sick; Flu; Vaccination adverse reaction; Red blotches; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema), ILLNESS (sick), INFLUENZA (Flu), IMMUNISATION REACTION (Vaccination adverse reaction) and RASH MACULAR (Red blotches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Immunocompromised. Concomitant products included PALBOCICLIB (IBRANCE) for an unknown indication.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced LYMPHOEDEMA (Lymphedema), ILLNESS (sick), INFLUENZA (Flu), IMMUNISATION REACTION (Vaccination adverse reaction) and RASH MACULAR (Red blotches). On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Accidental Underdose/Patient took booster instead of third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administartion/patient took booster instaed of third full dose). At the time of the report, LYMPHOEDEMA (Lymphedema), ILLNESS (sick), IMMUNISATION REACTION (Vaccination adverse reaction), RASH MACULAR (Red blotches), ACCIDENTAL UNDERDOSE (Accidental Underdose/Patient took booster instead of third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administartion/patient took booster instaed of third full dose) outcome was unknown and INFLUENZA (Flu) had resolved.            The patient got an injection every three months for the bones every three months.  The patient had received 2 doses of Moderna vaccine as well as the booster shot due to being immunocompromised. When the patient received the bosster shot she also got the flu vaccine. The patient stated had quite the reactions to the combination of the two and felt like had the flu for about a day and half. The patient had lymphedema in the left arm that would become red and blotchy at times when patient was sick. The patient thought this was due to the flu vaccine or the combination of the two.  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-2021-624962 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Suspected COVID-19
Clinical narrative: has mild symptoms of Covid very mild; Just feels off; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (has mild symptoms of Covid very mild) and FEELING ABNORMAL (Just feels off) in a male patient of an unknown age 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 SUSPECTED COVID-19 (has mild symptoms of Covid very mild) and FEELING ABNORMAL (Just feels off). At the time of the report, SUSPECTED COVID-19 (has mild symptoms of Covid very mild) and FEELING ABNORMAL (Just feels off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on concomitant medication were reported. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: No additional information reported in the follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: She had a reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (She had a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   No Medical History information was reported.  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She had a reaction). At the time of the report, IMMUNISATION REACTION (She had a reaction) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication information was reported. No treatment medication information was reported. Patient did not receive second dose. 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: Allergy to vaccine
Clinical narrative: she received her Moderna Covid19 vaccine last month, and had an allergic reaction to it.; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (she received her Moderna Covid19 vaccine last month, and had an allergic reaction to it.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (she received her Moderna Covid19 vaccine last month, and had an allergic reaction to it.). At the time of the report, ALLERGY TO VACCINE (she received her Moderna Covid19 vaccine last month, and had an allergic reaction to it.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry eye, Dysphonia, Myalgia, Oropharyngeal pain
Clinical narrative: Hoarse voice/Voice raspy; Sore throat; Dizzy/Felt Dizzy; Vaccination site stinging/stung; Muscle soreness/COVID shot caused sore muscle; Dry eyes; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eyes), DYSPHONIA (Hoarse voice/Voice raspy), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy/Felt Dizzy) and VACCINATION SITE PAIN (Vaccination site stinging/stung) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis.    Concomitant products included INFLUENZA VACCINE for Prophylactic vaccination.   On 09-Mar-2002, 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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. In 2021, the patient experienced DRY EYE (Dry eyes), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy/Felt Dizzy), VACCINATION SITE PAIN (Vaccination site stinging/stung) and MYALGIA (Muscle soreness/COVID shot caused sore muscle). On an unknown date, the patient experienced DYSPHONIA (Hoarse voice/Voice raspy). At the time of the report, DRY EYE (Dry eyes), DIZZINESS (Dizzy/Felt Dizzy), VACCINATION SITE PAIN (Vaccination site stinging/stung) and MYALGIA (Muscle soreness/COVID shot caused sore muscle) outcome was unknown and DYSPHONIA (Hoarse voice/Voice raspy) and OROPHARYNGEAL PAIN (Sore throat) was resolving.            No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality for the event(s) of COVID shot caused sore muscle, stung, felt dizzy and dry eyes, and voice raspy was not provided. The reporter's causality for the event(s) of sore throat with Humira (ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-625117 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Significant live follow up ( received updates to event information, reporter opinion of causality, suspect drug information, Dose details,concomitant drug information and narrative description).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Hoarse voice/Voice raspy; Sore throat; Dizzy/Felt Dizzy; Vaccination site stinging/stung; Muscle soreness/COVID shot caused sore muscle; Dry eyes; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eyes), DYSPHONIA (Hoarse voice/Voice raspy), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy/Felt Dizzy) and VACCINATION SITE PAIN (Vaccination site stinging/stung) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis.    Concomitant products included INFLUENZA VACCINE for Prophylactic vaccination.   On 09-Mar-2002, 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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. In 2021, the patient experienced DRY EYE (Dry eyes), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy/Felt Dizzy), VACCINATION SITE PAIN (Vaccination site stinging/stung) and MYALGIA (Muscle soreness/COVID shot caused sore muscle). On an unknown date, the patient experienced DYSPHONIA (Hoarse voice/Voice raspy). At the time of the report, DRY EYE (Dry eyes), DIZZINESS (Dizzy/Felt Dizzy), VACCINATION SITE PAIN (Vaccination site stinging/stung) and MYALGIA (Muscle soreness/COVID shot caused sore muscle) outcome was unknown and DYSPHONIA (Hoarse voice/Voice raspy) and OROPHARYNGEAL PAIN (Sore throat) was resolving.            No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality for the event(s) of COVID shot caused sore muscle, stung, felt dizzy and dry eyes, and voice raspy was not provided. The reporter's causality for the event(s) of sore throat with Humira (ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-625117 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Significant live follow up ( received updates to event information, reporter opinion of causality, suspect drug information, Dose details,concomitant drug information and narrative description).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, SARS-CoV-2 test
Clinical narrative: Exhaustion; Aching joints/was very achy in joints; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion) and ARTHRALGIA (Aching joints/was very achy in joints) in a 56-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 Rheumatoid arthritis.    No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate free. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced FATIGUE (Exhaustion) and ARTHRALGIA (Aching joints/was very achy in joints). In 2021, FATIGUE (Exhaustion) and ARTHRALGIA (Aching joints/was very achy in joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: (Positive) Positive. In November 2020, SARS-CoV-2 test: (Positive) Positive. In February 2021, SARS-CoV-2 test: (Negative) Negative.   No concomitant medication details were provided. No treatment medication details were provided.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for all the events was no reasonable possibility with 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.   This case was linked to MOD-2021-623818 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain
Clinical narrative: Lot of inflammation; Pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Lot of inflammation) and PAIN (Pain) in a 47-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 an unknown indication.    No Medical History information was reported.   On 08-Sep-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 09-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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Lot of inflammation) and PAIN (Pain). At the time of the report, INFLAMMATION (Lot of inflammation) and PAIN (Pain) outcome was unknown.     Booster made patient to stay in bed. But about five days after taking Rinvoq, started to feel little better with joint pain.  No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624995, MOD-2021-624996 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) in a 47-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 an unknown indication.    No Medical History information was reported.   On 08-Sep-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 09-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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation). At the time of the report, INFLAMMATION (Inflammation) outcome was unknown.     Patient had lot of inflammation and pain with COVID first dose and not as much inflammation with the second shot Booster made patient to stay in bed. But about five days after taking Rinvoq, started to feel little better with her joint pain.  No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624992, MOD-2021-624996 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inflammation
Clinical narrative: Inflammation; Have to stay in bed; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) and IMMUNISATION REACTION (Have to stay in bed) in a 47-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 an unknown indication.    The patient's past medical history included Inflammation (Patient had lot of inflammation and pain with covid first dose and not as much inflammation with the second shot) and Pain (Patient had lot of inflammation and pain with covid first dose and not as much inflammation with the second shot).   On 08-Sep-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 09-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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced INFLAMMATION (Inflammation) and IMMUNISATION REACTION (Have to stay in bed). At the time of the report, INFLAMMATION (Inflammation) and IMMUNISATION REACTION (Have to stay in bed) outcome was unknown.     Patient had lot of inflammation and pain with covid first dose and not as much inflammation with the second shot. Booster made patient to stay in bed. But about five days after taking Rinvoq, started to feel little better with her joint pain.   No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624992, MOD-2021-624995 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Infection
Clinical narrative: Breakthrough infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Breakthrough infection) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN 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, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Breakthrough infection). At the time of the report, INFECTION (Breakthrough infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  By the end of September moderna two covid 19 vaccine measured as 89 percent effective in march was only 58 percent effective. Amoung the patients 65 and older who were inoculated with the moderna vaccine those who developed the so called breakthrough infection were 76 percent less likely to die of covid 19 compared to unvaccinated veterans to the same age. Older patients who got pfizer biontech vaccine subsequently experienced breakthrough infection were 70 percent less likely to die of covid 19 compared to their invaccinated peers. And older patients who got single jab of J and J vaccine suffered a breakthrough infection were 52 percent less likely to die of covid 19 compared to who did not get any shot.  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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Sinusitis
Clinical narrative: Inappropriate schedule of vaccine administered; Sinus infection; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), SINUSITIS (Sinus infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 32-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 Ankylosing spondylitis.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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. In March 2021, the patient experienced ILLNESS (Sickness). On 18-Nov-2021, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ILLNESS (Sickness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and SINUSITIS (Sinus infection) had not resolved.       No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Photosensitivity reaction, Psoriasis
Clinical narrative: Psoriasis flare-up/breakouts on arms and scalp; Felt ill; Sun sensitivity/being in sun made worse; Pain in arm/arm sore; Swollen arm/arm swelled and puffy; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/breakouts on arms and scalp), PERIPHERAL SWELLING (Swollen arm/arm swelled and puffy), MALAISE (Felt ill), PHOTOSENSITIVITY REACTION (Sun sensitivity/being in sun made worse) and PAIN IN EXTREMITY (Pain in arm/arm sore) in a 69-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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PERIPHERAL SWELLING (Swollen arm/arm swelled and puffy). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/breakouts on arms and scalp), MALAISE (Felt ill), PHOTOSENSITIVITY REACTION (Sun sensitivity/being in sun made worse) and PAIN IN EXTREMITY (Pain in arm/arm sore). At the time of the report, PSORIASIS (Psoriasis flare-up/breakouts on arms and scalp) had not resolved and PERIPHERAL SWELLING (Swollen arm/arm swelled and puffy), MALAISE (Felt ill), PHOTOSENSITIVITY REACTION (Sun sensitivity/being in sun made worse) and PAIN IN EXTREMITY (Pain in arm/arm sore) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality for the event(s) of arm swelled and puffy, arm sore and felt ill with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of psoriasis flare up/breakouts on arms and scalp/being in sun made worse unknown onset 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.   This case was linked to MOD-2021-625124 (Patient Link).