chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Neoplasm malignant
Clinical narrative: Headache; Cancer; FEEL SICK; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a 53-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 Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to Severe).   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant) and MALAISE (FEEL SICK). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, NEOPLASM MALIGNANT (Cancer), MALAISE (FEEL SICK) and HEADACHE (Headache) had not resolved.            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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of CANCER, FEEL SICK and HEADACHE with HUMIRA (ADALIMUMAB) was a reasonable possibility.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 53-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Neoplasm malignant, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease can be a contributory factor for neoplasm malignant. 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, concerning a 53-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Neoplasm malignant, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Underlying Crohn´s disease can be a contributory factor for neoplasm malignant. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Bilateral swelling under both eyes; This spontaneous case was reported by a nurse and describes the occurrence of EYE SWELLING (Bilateral swelling under both eyes) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Restylane Silk on 06-Nov-2020. Past adverse reactions to the above products included No adverse event with Restylane Silk.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EYE SWELLING (Bilateral swelling under both eyes). At the time of the report, EYE SWELLING (Bilateral swelling under both eyes) 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.   The concomitant medication was not reported by reporter. The Nurse reported that a patient was seen on 06-Nov-2020 and injected with Restylane Silk in the tear troughs bilaterally. The Nurse reported the patient received a covid-19 vaccine some time in Nov-2021 and on 12-Nov-2021 the patient came back to the office after receiving the vaccine presenting with bilateral swelling under both eyes where the Restylane Silk was placed a year earlier. Nurse reported the swelling also had some soft nodules under the eyes. Nurse reported the patient was scheduled to have the Silk dissolved but the patient failed the appointment and never came back to the office. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 69.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient 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 INFLUENZA VACCINE for Flu.    Concurrent medical conditions included Primary biliary cirrhosis (Primary biliary cirrhosis She takes medication for cirrhosis of the liver but it's not from drinking, she has primary biliary cirrhosis. States that started many many years ago, over 20 years. Caller does not know name of medication.) and Emphysema (Emphysema diagnosed in the last 3 years and she takes a once a day inhaler. Caller does not know name of medication.).   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., third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 18-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.            Ethnicity reported.  No concomitant medications were reported.  Reported that patient started paxlovid on 18-Apr-2022 and experienced massive headache earlier the morning of 19-Apr-2022 around 3 am and was persisting. Reported that patient got COVID-19 and was at high risk. Reported that patient was boostered and everything and she got it. Reported that patient received First and second dose of Moderna and booster was Pfizer COVID-19 vaccine. Reported that her last dose was over 6 month ago, she has not gotten the most recent booster. Reported that reporter think patient got her flu shot that same day when Pfizer vaccine was administered.  Reported that patient not received any prior vaccination within four weeks. Reported that tested positive for COVID-19 this past Sunday, she did a home test.   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-2022-621378 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection, Influenza like illness
Clinical narrative: Flu like symptoms; Bacterial infection; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and BACTERIAL INFECTION (Bacterial infection) 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 Crohn's disease.    There was no reported medical history.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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) UNK, Citrate free. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and BACTERIAL INFECTION (Bacterial infection). The patient was treated with AZITHROMYCIN (ZITHROMAX Z-PACK) at an unspecified dose and frequency. In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and BACTERIAL INFECTION (Bacterial infection) had resolved.      Formulation for HUMIRA was given as Solution for injection in pre-filled pen.  The reporter's causality for the events of Influenza like illness and bacterial infection with HUMIRA(ADALIMUMAB) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CONTRACTED COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (CONTRACTED COVID) in an adult 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.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (CONTRACTED COVID). At the time of the report, COVID-19 (CONTRACTED COVID) outcome was unknown.            Concomitant Drugs Not Reported. No treatment information was 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.  Company Comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Follow-up added-received updates to event information.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the 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.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Immunisation reaction
Clinical narrative: FLOORED; FELT ILL; SEVERE FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of FALL (FLOORED), IMMUNISATION REACTION (FELT ILL) and FATIGUE (SEVERE FATIGUE) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for an unknown indication.    Patient had no known allergies.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. and IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day. On an unknown date, the patient experienced FALL (FLOORED), IMMUNISATION REACTION (FELT ILL) and FATIGUE (SEVERE FATIGUE). At the time of the report, FALL (FLOORED), IMMUNISATION REACTION (FELT ILL) and FATIGUE (SEVERE FATIGUE) was resolving.            No concomitant drug taken by patient.  On an unknown date, the patient experienced severe fatigue, felt ill and floored after dose of Moderna booster. Treatment details were not 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Fatigue, Headache
Clinical narrative: ULCERATIVE COLITIS FLARE/WORSE; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE/WORSE) in a 27-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 Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In July 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to citrate free. In 2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). In September 2021, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE/WORSE) (seriousness criterion medically significant). In 2021, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE/WORSE), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the event(s) of tired and headache with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of ulcerative colitis flare/worse with Humira(adalimumab) was a reasonable possibility.  Company comment: This is a spontaneous case concerning a 27-year-old female patient with Ulcerative colitis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Colitis ulcerative flare, on an unknown date after an unspecified dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 27-year-old female patient with Ulcerative colitis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event Colitis ulcerative flare, on an unknown date after an unspecified dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (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. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an adult male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved 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 adult male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Joint swelling, Neuralgia
Clinical narrative: Peripheral neuropathic pain/nerve pain in feet; Swelling of wrists; wrist pain/pain in wrists; Weakness/weak for about a day; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Peripheral neuropathic pain/nerve pain in feet), ASTHENIA (Weakness/weak for about a day), JOINT SWELLING (Swelling of wrists) and ARTHRALGIA (wrist pain/pain in wrists) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 Vaccine (1st dose (1 in 1 Once), Route Intramuscular) on 21-Jan-2021, PFIZER BIONTECH COVID-19 Vaccine (2nd dose (1 in 1 Once), Route Intramuscular) on 15-Feb-2021, PFIZER BIONTECH COVID-19 Vaccine (3rd dose (1 in 1 Once) and Route Intramuscular) on 19-Aug-2021. Past adverse reactions to the above products included Vaccination site pain with PFIZER BIONTECH COVID-19 Vaccine, PFIZER BIONTECH COVID-19 Vaccine and PFIZER BIONTECH COVID-19 Vaccine. Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) First dose. In 2022, the patient experienced ASTHENIA (Weakness/weak for about a day). On an unknown date, the patient experienced NEURALGIA (Peripheral neuropathic pain/nerve pain in feet), JOINT SWELLING (Swelling of wrists) and ARTHRALGIA (wrist pain/pain in wrists). In 2022, ASTHENIA (Weakness/weak for about a day) had resolved. At the time of the report, NEURALGIA (Peripheral neuropathic pain/nerve pain in feet), JOINT SWELLING (Swelling of wrists) and ARTHRALGIA (wrist pain/pain in wrists) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient had swelling and pain in wrists. She had nerve pain in feet. In 2022, following the Moderna Covid-19 Vaccine she was weak for about a day. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters Causality for rinvoq(upadacitinib) with response to all the events were not provided. Action taken with the Co-suspect vaccine was unknown.  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.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza
Clinical narrative: flu; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu) and FATIGUE (fatigue) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Previously administered products included for Drug use for unknown indication: SULFA (SULFA DRUGS ALLERGY MENIFESTED BY FACE SWELLING) and PENICILLIN (PENICILLIN ALLERGY MENIFESTED BY HIVES). Past adverse reactions to the above products included Hives with PENICILLIN; and Swelling of face with SULFA. Concurrent medical conditions included Non-tobacco user.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) Unknown. On 18-Apr-2021, the patient experienced INFLUENZA (flu). In 2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Unknown. On 18-Apr-2021, INFLUENZA (flu) had resolved. At the time of the report, FATIGUE (fatigue) had not resolved.            Patient was non alcohol user.  No concomitant medications were reported.  The patient did not recall of having weakness after receiving the second dose of Moderna vaccine. She stated that it was like a flu and fatigue that she experienced for a day and she was okay after a day.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of influenza was no reasonable possibility and the  reporter's causality for the event of fatigue was not provided with RINVOQ(UPADACITINIB) .  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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Hypoaesthesia
Clinical narrative: Stomach pain; COVID-19; Numbness in face; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), COVID-19 (COVID-19) and HYPOAESTHESIA (Numbness in face) in a 31-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 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness in face). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and COVID-19 (COVID-19). On 01-Jun-2021, HYPOAESTHESIA (Numbness in face) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and COVID-19 (COVID-19) had resolved.            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 for the event(s) of second vaccine caused face to numb, had covid and stomach pain 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.
Sex: M
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: Excessive phlegm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Excessive phlegm) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-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) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Excessive phlegm). At the time of the report, PRODUCTIVE COUGH (Excessive phlegm) had not resolved.            No concomitant medication was reported. No treatment medication was reported.  The reporter's causality for the event of excessive phlegm was not provided for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: Hands Swelling; Felt Tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hands Swelling) and FATIGUE (Felt Tired) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In 2022, the patient experienced PERIPHERAL SWELLING (Hands Swelling) and FATIGUE (Felt Tired). At the time of the report, PERIPHERAL SWELLING (Hands Swelling) and FATIGUE (Felt Tired) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2022 Humira was really not helping. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Product dispensing error
Clinical narrative: Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DISPENSING ERROR (Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 72-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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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) CF. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced PRODUCT DISPENSING ERROR (Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe). At the time of the report, PRODUCT DISPENSING ERROR (Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (Flu like symptoms) to be related. No further causality assessment was provided for PRODUCT DISPENSING ERROR (Wrong dosage form  dispensed/possible dispensing error/accustomed to receiving the pen but had been receiving the syringe).    No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of product dispensing error and influenza like illness was not provided with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Illness, Malaise, Rhinorrhoea
Clinical narrative: Sniffles; Ill feeling/ ILL; Sickness/ Sick; Arthritis/ ARTHIRITIS IN WRIST/ANKLES/KNEES; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Sniffles), MALAISE (Ill feeling/ ILL), ILLNESS (Sickness/ Sick) and ARTHRITIS (Arthritis/ ARTHIRITIS IN WRIST/ANKLES/KNEES) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   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) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Sniffles), MALAISE (Ill feeling/ ILL), ILLNESS (Sickness/ Sick) and ARTHRITIS (Arthritis/ ARTHIRITIS IN WRIST/ANKLES/KNEES). At the time of the report, RHINORRHOEA (Sniffles) and ILLNESS (Sickness/ Sick) outcome was unknown and MALAISE (Ill feeling/ ILL) and ARTHRITIS (Arthritis/ ARTHIRITIS IN WRIST/ANKLES/KNEES) had resolved.      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.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 66-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) injection for an unknown indication.    No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-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) Discontinued. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            Concomitant products were not provided. Treatment medication were not 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: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID-19 positive) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 25-Apr-2022, the patient experienced COVID-19 (Tested COVID-19 positive). At the time of the report, COVID-19 (Tested COVID-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event of tested COVID-19 positive with Rinvoq (upadacitinib) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Soreness; Could not move hands; Mild Headache; Fatigue; Hand pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Soreness), MOBILITY DECREASED (Could not move hands), HEADACHE (Mild Headache), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Hand pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Soreness), MOBILITY DECREASED (Could not move hands), HEADACHE (Mild Headache), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Hand pain). At the time of the report, PAIN (Soreness), HEADACHE (Mild Headache) and FATIGUE (Fatigue) had resolved and MOBILITY DECREASED (Could not move hands) and PAIN IN EXTREMITY (Hand pain) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash to his nose and eye lids/ has the symptoms on his cheeks and it comes and goes; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Itchy rash to his nose and eye lids/ has the symptoms on his cheeks and it comes and goes) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Nasal polyps.    No Medical History information was reported.   In August 2020, the patient started DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced RASH PRURITIC (Itchy rash to his nose and eye lids/ has the symptoms on his cheeks and it comes and goes). At the time of the report, RASH PRURITIC (Itchy rash to his nose and eye lids/ has the symptoms on his cheeks and it comes and goes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient experienced small itchy rash to his nose and eye lids, and has symptoms on his cheeks and it comes and goes.  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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Sick/felt unwell since the booster COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Sick/felt unwell since the booster COVID-19 vaccine) in a 71-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]) solution for injection for Psoriasis.    Concurrent medical conditions included Psoriasis.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On 10-Feb-2022, the patient experienced IMMUNISATION REACTION (Sick/felt unwell since the booster COVID-19 vaccine). At the time of the report, IMMUNISATION REACTION (Sick/felt unwell since the booster COVID-19 vaccine) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. She has been a little sick stated she had not felt well since the booster.  The reporter's causality for the event of immunisation reaction was not provided with SKYRIZI(RISANKIZUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Right hand flares up after taking booster Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Right hand flares up after taking booster Moderna shot) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Right hand flares up after taking booster Moderna shot). At the time of the report, CONDITION AGGRAVATED (Right hand flares up after taking booster Moderna shot) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event of right hand flares up after taking booster Moderna shot was not provided for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Gastroenteritis viral
Clinical narrative: Stomach virus; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL (Stomach virus) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced GASTROENTERITIS VIRAL (Stomach virus). At the time of the report, GASTROENTERITIS VIRAL (Stomach virus) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Breast cancer) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 09-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 09-Dec-2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. In March 2022, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (Breast cancer) had not resolved.            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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. On 22 Mar 2022 patient saw her physician to discuss. Physician instructed to hold her next dose of Skyrizi to had a better understanding of the treatment plan for breast cancer. Treatment medications were not reported.  The reporter's causality for the event(s) of breast cancer was not provided. Abbvie's opinion is that there is no reasonable possibility that the event of breast cancer is related to Skyrizi (risankizumab).  Company Comment: This is a spontaneous case concerning a 57-year-old female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Breast cancer, approximately 14 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved 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 57-year-old female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Breast cancer, approximately 14 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: Pain in joint involving hand/ Pain in Knuckles; Chills/ First COVID Vaccine caused chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joint involving hand/ Pain in Knuckles), CHILLS (Chills/ First COVID Vaccine caused chills) and FATIGUE (Fatigue) 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.    There was no reported patient's medical history.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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. In 2021, the patient experienced CHILLS (Chills/ First COVID Vaccine caused chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced ARTHRALGIA (Pain in joint involving hand/ Pain in Knuckles). At the time of the report, ARTHRALGIA (Pain in joint involving hand/ Pain in Knuckles) had not resolved and CHILLS (Chills/ First COVID Vaccine caused chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  It was unknown if patient was enrolled in a COVID-19 Vaccine trail.  No treatment medication reported.  Primary reporter contact for lot number information was unsuccessful.   The reporter causality for co-suspect of Humira for the events Pain in Knuckles, chills and fatigue was not provided.   This case was linked to MOD-2022-624832 (Patient Link).