chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pruritus, Pyrexia, Wheezing
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), COUGH (Coughing), PYREXIA (Fever), WHEEZING (Wheezing) and CHILLS (Chills) in a 66-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    Concurrent medical conditions included Psoriasis.   In 2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. In 2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. On 24-Sep-2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRURITUS (Itching). On 09-Nov-2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction), COUGH (Coughing), PYREXIA (Fever), WHEEZING (Wheezing), CHILLS (Chills), DECREASED APPETITE (Appetite lost) and FATIGUE (Tiredness). On 10-Nov-2021, IMMUNISATION REACTION (Vaccination adverse reaction), COUGH (Coughing), PYREXIA (Fever), WHEEZING (Wheezing), CHILLS (Chills), DECREASED APPETITE (Appetite lost) and FATIGUE (Tiredness) had resolved. At the time of the report, PRURITUS (Itching) outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: Fever.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment medication information provided No concomitant medication information provided  It was unknown if patient was enrolled in a covid-19 vaccine trial.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Fatigue, Nasopharyngitis, Pain
Clinical narrative: Tiredness; Cold; Pain; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PAIN (Pain), DIZZINESS (Dizziness) and FATIGUE (Tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 04-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 received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced NASOPHARYNGITIS (Cold), PAIN (Pain) and DIZZINESS (Dizziness). In 2021, FATIGUE (Tiredness) had resolved. At the time of the report, NASOPHARYNGITIS (Cold) was resolving, PAIN (Pain) had not resolved and DIZZINESS (Dizziness) outcome was unknown.            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: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Patient received COVID-19 Vaccine manufactured by Moderna. Patient received COVID-19 Vaccine manufactured by Johnson and Johnson.  On an unknown date, the patient experienced fatigue for a day and it was resolved.  Treatment information was not provided.  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, COVID19
Symptoms: Chills, Fatigue, Hot flush, Pyrexia
Clinical narrative: Chills; Fever; Hot Flushes; Fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), HOT FLUSH (Hot Flushes) and FATIGUE (Fatigue) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), HOT FLUSH (Hot Flushes) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), PYREXIA (Fever), HOT FLUSH (Hot Flushes) and FATIGUE (Fatigue) outcome was unknown. Not Provided          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
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bronchitis, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Acute bronchitis; COVID BOOSTER CAUSED ARM TO SWELL/ Vaccination site swelling; BOOSTER CAUSED ARM TURN RED/ Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Acute bronchitis), VACCINATION SITE SWELLING (COVID BOOSTER CAUSED ARM TO SWELL/ Vaccination site swelling) and VACCINATION SITE ERYTHEMA (BOOSTER CAUSED ARM TURN RED/ Vaccination site erythema) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Diabetes. Concomitant products included LIRAGLUTIDE (VICTOZA) and METFORMIN for Diabetes.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced BRONCHITIS (Acute bronchitis), VACCINATION SITE SWELLING (COVID BOOSTER CAUSED ARM TO SWELL/ Vaccination site swelling) and VACCINATION SITE ERYTHEMA (BOOSTER CAUSED ARM TURN RED/ Vaccination site erythema). At the time of the report, BRONCHITIS (Acute bronchitis), VACCINATION SITE SWELLING (COVID BOOSTER CAUSED ARM TO SWELL/ Vaccination site swelling) and VACCINATION SITE ERYTHEMA (BOOSTER CAUSED ARM TURN RED/ Vaccination site erythema) had resolved.            On unknown dates, the patient experienced acute bronchitis, COVID-19 booster caused arm to swell and turn red. On an unknown date, COVID-19 booster caused arm to swell and turn red resolved. Treatment information was not provided.  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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore/Pain in arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced VACCINATION SITE PAIN (Sore/Pain in arm). At the time of the report, VACCINATION SITE PAIN (Sore/Pain in arm) was resolving. No concomitant medication provided. No treatment information mentioned. In December 2021, patient experienced sore arm or pain in arm as a result of the COVID booster from Moderna. Reporters causality of events with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site bruising, Vaccination site pain
Clinical narrative: Injection site bruising; Vaccination site pain; Fatigue; Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MALAISE (Feeling unwell), VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE PAIN (Vaccination site pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 28-Feb-2021 to an unknown date for COVID-19 vaccination.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue) and MALAISE (Feeling unwell). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, FATIGUE (Fatigue) and MALAISE (Feeling unwell) outcome was unknown and VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE PAIN (Vaccination site pain) had not resolved. 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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No  treatment medication provided
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse Event; 14 year old female patient received the Moderna vaccine in error on 21 June at another facility; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old female patient received the Moderna vaccine in error on 21 June at another facility) 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.     No Medical History information was reported.    On 21-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old female patient received the Moderna vaccine in error on 21 June at another facility). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old female patient received the Moderna vaccine in error on 21 June at another facility) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old female patient received the Moderna vaccine in error on 21 June at another facility).    Concomitant medications were not reported.  The 14 years patient had received the Moderna vaccine in error at another facility. Moderna was not approved for children under 18 years of age. Facility that administered the vaccine told the patient to start over with Pfizer. So the patient received the first dose of Pfizer.  No treatment information was provided by the reporter.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Photosensitivity reaction
Clinical narrative: VACCINE CAUSED TO FEEL PARALYZED; SUN DAMAGE; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (VACCINE CAUSED TO FEEL PARALYZED) and PHOTOSENSITIVITY REACTION (SUN DAMAGE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HYPOAESTHESIA (VACCINE CAUSED TO FEEL PARALYZED) and PHOTOSENSITIVITY REACTION (SUN DAMAGE). At the time of the report, HYPOAESTHESIA (VACCINE CAUSED TO FEEL PARALYZED) and PHOTOSENSITIVITY REACTION (SUN DAMAGE) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  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. Duration for event numbness was 24 hour. 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: COVID-19 pneumonia; vaccination failure; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in an 80-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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant) and VACCINATION FAILURE (vaccination failure). At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) was resolving and VACCINATION FAILURE (vaccination failure) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   No concomitant medication information was  provided. It was reported that the patient experienced pneumonia in chest from COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medication information was provided.  Company Comment: This is a spontaneous case concerning an 80-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of COVID-19 pneumonia, approximately 7 months after receiving the second dose of mRNA-1273 vaccine. Vaccination failure was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 80-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of COVID-19 pneumonia, approximately 7 months after receiving the second dose of mRNA-1273 vaccine. Vaccination failure was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 52-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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). In January 2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.            No concomitant medication provided. No treatment information mentioned.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The formulation for Co-suspect product Humira was reported as Solution for injection in pre-filled pen  On an unknown date, patient had back surgery, a spinal operation NOS. Trying to recover as of 04JAN2022.  Somewhere in JAN2021, the patient felt like flu and event resolved.   Reporters causality for event with Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-624624 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Significant follow up. Event added to narrative.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Pyrexia, Vaccination site swelling
Clinical narrative: VERY SICK; COVID ARM SWELLING; Fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (VERY SICK), VACCINATION SITE SWELLING (COVID ARM SWELLING), PYREXIA (Fever) and COVID-19 (COVID-19) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In December 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ILLNESS (VERY SICK), VACCINATION SITE SWELLING (COVID ARM SWELLING) and PYREXIA (Fever). At the time of the report, ILLNESS (VERY SICK), VACCINATION SITE SWELLING (COVID ARM SWELLING), PYREXIA (Fever) and COVID-19 (COVID-19) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Symptom recurrence, Therapeutic product effect decreased
Clinical narrative: Symptom recurrence; Drug effect decreased; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (Symptom recurrence) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) 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 Psoriatic arthritis.    No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced SYMPTOM RECURRENCE (Symptom recurrence) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). At the time of the report, SYMPTOM RECURRENCE (Symptom recurrence) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) had not resolved.            No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 25-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 Crohn's disease.    No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Nov-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 23-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 06-Dec-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Influenza like illness, Pain
Clinical narrative: Flu like symptoms; BODY ACHES; Confusion; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (BODY ACHES), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    Concurrent medical conditions included Crohn's disease and Rheumatoid arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (BODY ACHES), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (BODY ACHES), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue) was resolving.            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: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Revaccination with different COVID-19 vaccine; Extra dose administered; Interchange of vaccine products; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), EXTRA DOSE ADMINISTERED (Extra dose administered), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) 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 (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 dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), EXTRA DOSE ADMINISTERED (Extra dose administered), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), EXTRA DOSE ADMINISTERED (Extra dose administered), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment drugs were reported. Patient had 18 shots of Pfizer and Modera.  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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sight of injection very painful for 3 days/Could not sleep on that arm) in a 27-year-old female 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 VACCINATION SITE PAIN (sight of injection very painful for 3 days/Could not sleep on that arm). At the time of the report, VACCINATION SITE PAIN (sight of injection very painful for 3 days/Could not sleep on that arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided. No treatment medication details were provided.  While driving in the car 10-Oct-2021, patient mentioned that she received a vaccination and sight of injection very painful for 3 days. 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
Clinical narrative: Sore/Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore/Achy) 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.    No Medical History information was reported.   On 17-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 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Sore/Achy). The patient was treated with HYDROXYCHLOROQUINE at an unspecified dose and frequency. At the time of the report, PAIN (Sore/Achy) outcome was unknown.            No concomitant medication provided.  Patient reported being sore and achy.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal ulcer, SARS-CoV-2 antibody test
Clinical narrative: Nasal ulcer; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL ULCER (Nasal ulcer) and FATIGUE (Tiredness) 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 IBRUTINIB (IMBRUVICA) capsule for Chronic lymphoid leukemia.    Concurrent medical conditions included Chronic lymphoid leukemia and Immunodeficiency.   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 24-Nov-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. In 2021, the patient experienced NASAL ULCER (Nasal ulcer) and FATIGUE (Tiredness). At the time of the report, NASAL ULCER (Nasal ulcer) and FATIGUE (Tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: (Negative) Negative.         No concomitant medication provided. Patient had non serious events of sores in both nostrils, did not believe that developed antibodies  From the covid vaccinations due to low immune system and tired with IMBRUVICA (IBRUTINIB).   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    The reporter's causality for the event(s) of sores in both nostrils, did not believe that developed antibodies from the covid vaccinations due to low immune system onset in 2021 and did not believe that developed  Antibodies from the covid vaccinations due to low immune system onset in 2021 was not provided. The reporter's causality for the event(s) of tired with IMBRUVICA(IBRUTINIB) was a reasonable possibility. No treatment medication 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   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Significant live follow up reporter's causality updated.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: Pretty sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Pretty sick) 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 COVID-19 prophylaxis.    No Medical History information was reported.   On 21-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-Aug-2021, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. 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 ILLNESS (Pretty sick). At the time of the report, ILLNESS (Pretty sick) 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.  It was reported that patient received first shot on 21-Jul-21 and final on 19-Aug-21 After vaccination patient experinced headaches.  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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Feeling abnormal, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling abnormal), BACK PAIN (Back pain), CHILLS (Chills), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Pain in hip) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis. 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 14-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) Citrate free. In 2021, the patient experienced FEELING ABNORMAL (Feeling abnormal) and CHILLS (Chills). In June 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced BACK PAIN (Back pain) and ARTHRALGIA (Pain in hip). At the time of the report, FEELING ABNORMAL (Feeling abnormal), BACK PAIN (Back pain), CHILLS (Chills), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Pain in hip) outcome was unknown. Concomitant product use was not provided by the reporter. The patient felt she was going to sick, sore arm with COVID-19 vaccine, back pain and hip pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided. The reporter's causality for the events of chills after second COVID-19 vaccine, patient felt she was going to get sick, sore arm with covid-19 vaccine, back pain and hip pain with Humira was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; Vaccination faliure; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 62-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) injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 28-Nov-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination faliure). The patient was hospitalized on 28-Nov-2021 due to COVID-19. At the time of the report, COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination faliure) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided.  It was reported that the patient remained in hospital as of 16-Dec-2021.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.  Company Comment: This is a spontaneous case concerning a 62-year-old male patient with no relevant medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Vaccination failure was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 62-year-old male patient with no relevant medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Vaccination failure was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Rheumatoid arthritis, Sinusitis
Clinical narrative: Bronchitis; Sinusitis; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-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 June 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced BRONCHITIS (Bronchitis) and SINUSITIS (Sinusitis). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BRONCHITIS (Bronchitis) and SINUSITIS (Sinusitis) outcome was unknown.            Company comment: This is a spontaneous case concerning a 54-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the non-serious unexpected AESI Rheumatoid arthritis, that occurred on the same month after the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623756.; Sender's Comments: Company comment: This is a spontaneous case concerning a 54-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the non-serious unexpected AESI Rheumatoid arthritis, that occurred on the same month after the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Lost smell; Lost taste; Exposure to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposure to COVID-19), ANOSMIA (Lost smell) and AGEUSIA (Lost taste) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-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) at an unspecified dose. On 07-Dec-2021, the patient experienced ANOSMIA (Lost smell) and AGEUSIA (Lost taste). In December 2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposure to COVID-19), ANOSMIA (Lost smell) and AGEUSIA (Lost taste) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2021, SARS-CoV-2 test: (Negative) Negative.         No concomitant medication provided. No treatment information mentioned.  Patient reported that in DEC2021, they were exposed to COVID. On 07DEC2021, lost smell and lost taste.  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: Vascular graft
Clinical narrative: one had triple bypass; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR GRAFT (one had triple bypass) 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 VASCULAR GRAFT (one had triple bypass). At the time of the report, VASCULAR GRAFT (one had triple bypass) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: Friend got a booster dose of Moderna after a primary series of Moderna. Full dose; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Friend got a booster dose of Moderna after a primary series of Moderna. Full dose) and NO ADVERSE EVENT (No adverse event) 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 third 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Friend got a booster dose of Moderna after a primary series of Moderna. Full dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Friend got a booster dose of Moderna after a primary series of Moderna. Full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Reporters friend took the booster dose of Moderna after primary series of Moderna, but took a full 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: U
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: Diabetes; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes) 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 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. On an unknown date, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (Diabetes) outcome was unknown.            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.   Reporter did not allow further contact