chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
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 female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Concomitant Drugs Not Reported. On an unknown date, the patient experienced HUMIRA SEEMED LESS EFFECTIVE AFTER HAD COVID. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of HUMIRA SEEMED LESS EFFECTIVE AFTER HAD COVID unknown onset and HUMIRA SEEMED LESS EFFECTIVE AFTER HAD COVID unknown onset with HUMIRA(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment; This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after receiving the 2nd dose of mRNA-1273 vaccine and co-suspect drug Adalimumab. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received 1st dose of mRNA-1273 vaccine 30 days prior to the 2nd dose. Co-suspect drug Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after receiving the 2nd dose of mRNA-1273 vaccine and co-suspect drug Adalimumab. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received 1st dose of mRNA-1273 vaccine 30 days prior to the 2nd dose. Co-suspect drug Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
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 a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Joint pain.    No Medical History information was reported.   In 2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). In 2021, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Patient started Rinvoq in 2021 and already feels huge improvement with joint pain. He was hospitalized with covid and released. No pain still with his joints, he attributes to Rinvoq. No treatment medication were reported. It was reported that there is no reasonable possibility that the event of COVID is related to 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.  Company Comment: This is a spontaneous case concerning a 62-year-old male patient with no reported medical history, who was hospitalized due to the unexpected, 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 resolved within the same year. 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 reported medical history, who was hospitalized due to the unexpected, 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 resolved within the same year. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: SORENESS with HUMIRA (ADALIMUMAB); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (SORENESS with HUMIRA (ADALIMUMAB)) in a patient of an unknown age and gender 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 an unknown date, the patient received 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 PAIN (SORENESS with HUMIRA (ADALIMUMAB)). At the time of the report, PAIN (SORENESS with HUMIRA (ADALIMUMAB)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  on an unknown date, the patient experienced soreness. covid-19 vaccine was also considered suspect.  It was unknown if patient was enrolled in a covid-19 vaccine trial. on unknown date, patient received 1st dose covid-19 vaccine manufactured by moderna. on an unknown date, patient received 2nd dose covid-19 vaccine manufactured by moderna. primary reporter contact for lot number information was not available.  Causality for humira (adalimumab), the reporter's causality for the event(s) of soreness was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood cholesterol, Blood cholesterol increased, Pyrexia
Clinical narrative: CHOLESTEROL LEVEL UP; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD CHOLESTEROL INCREASED (CHOLESTEROL LEVEL UP) and PYREXIA (Low grade fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PYREXIA (Low grade fever). On an unknown date, the patient experienced BLOOD CHOLESTEROL INCREASED (CHOLESTEROL LEVEL UP). At the time of the report, BLOOD CHOLESTEROL INCREASED (CHOLESTEROL LEVEL UP) was resolving and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: Cholesterol level up.         No relevant concomitant medications were reported.   The reporters causality for the event of cholesterol level up with rinvoq (upadacitinib) was no reasonable possibility. The reporters causality for the events of low grade fever was not provided.  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
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Fatigue, Hypersensitivity, Nasopharyngitis
Clinical narrative: Colds; Allergies; COVID vaccines side effects/feeling tired; COVID vaccines side effects/light headed; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Colds), DIZZINESS (COVID vaccines side effects/light headed), HYPERSENSITIVITY (Allergies) and FATIGUE (COVID vaccines side effects/feeling tired) in a 50-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.    No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced DIZZINESS (COVID vaccines side effects/light headed) and FATIGUE (COVID vaccines side effects/feeling tired). On an unknown date, the patient experienced NASOPHARYNGITIS (Colds) and HYPERSENSITIVITY (Allergies). At the time of the report, NASOPHARYNGITIS (Colds), DIZZINESS (COVID vaccines side effects/light headed), HYPERSENSITIVITY (Allergies) and FATIGUE (COVID vaccines side effects/feeling tired) was resolving.            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 was reported.  The patient had been having allergies. Patient was feeling tired and had been getting colds. The patient had received both of covid vaccines and had some side effects like feeling tired and light headed. Patient agrees to have physician contacted.    No treatment medication was reported.  The reporter's causality for the events of allergies, COVID vaccines side effects/feeling tired and light headed onset in 2021, COVID vaccines side effects/feeling tired and light headed onset in 2021 and colds was not provided for co-suspect Skyrizi.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: she felt l ke she got hit by a truck so it was much worse; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she felt l ke she got hit by a truck so it was much worse) 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 (COMIRNATY) 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 third dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form and first dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she felt l ke she got hit by a truck so it was much worse). At the time of the report, FEELING ABNORMAL (she felt l ke she got hit by a truck so it was much worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gait inability, Malaise
Clinical narrative: Felt severely ill; Unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt severely ill) and GAIT INABILITY (Unable to walk) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt severely ill) and GAIT INABILITY (Unable to walk). At the time of the report, MALAISE (Felt severely ill) and GAIT INABILITY (Unable to walk) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  Patient was unable to go to work for more than a weekend was unable to return to work later.The reporter causality for the events with respect to Rinvoq was provided as not reported.  The treatment medication was not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain/soreness at injection spot from covid-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain/soreness at injection spot from covid-19 vaccination) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in. In August 2021, the patient experienced VACCINATION SITE PAIN (pain/soreness at injection spot from covid-19 vaccination). At the time of the report, VACCINATION SITE PAIN (pain/soreness at injection spot from covid-19 vaccination) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Action taken of co-suspect ADALIMUMAB (HUMIRA) was reported as unknown with respect to the event.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  It was reported Primary reporter contact for lot number information was unsuccessful.  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   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Live follow-up received additional no new information was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for 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 ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced COVID-19 (Positive for COVID). At the time of the report, COVID-19 (Positive for COVID) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On an unknown date, the patient experienced positive for COVID. 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.  Company comment: This spontaneous case concerns an adult female of unknown age, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event was resolving. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This spontaneous case concerns an adult female of unknown age, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event was resolving. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node disorder; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node disorder) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node disorder). At the time of the report, LYMPHADENOPATHY (Lymph node disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported.   It was reported that Humira was not effective.  The reporter's causality for the event(s) of issue with lymph nodes by ear and Humira was not effective with Humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just a slightlly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Just a slightlly sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Just a slightlly sore arm). At the time of the report, PAIN IN EXTREMITY (Just a slightlly sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Both Pfizer shots, just a slightly sore arm after. However, a good friend had fever, chills, headaches, and body aches for three days after her second shot. 4 closest blood relatives, brother who had Moderna and niece and 2 nephews with both Pfizer had the same results that reporter had.  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
Symptoms: Immunisation reaction
Clinical narrative: Covid-19 vaccine made patient sick; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Covid-19 vaccine made patient sick) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, On an unknown date, the patient experienced IMMUNISATION REACTION (Covid-19 vaccine made patient sick). At the time of the report, IMMUNISATION REACTION (Covid-19 vaccine made patient sick) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 vaccine trial. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Candida infection, Feeling guilty, Stomatitis
Clinical narrative: Mouth sores occasionally; Guilt feeling; Had thrush following vaccine; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (Mouth sores occasionally), CANDIDA INFECTION (Had thrush following vaccine) and FEELING GUILTY (Guilt feeling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Aug-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) Solution for injection in pre-filled pen and METHOTREXATE (unknown route) at an unspecified dose. In 2021, the patient experienced CANDIDA INFECTION (Had thrush following vaccine). On an unknown date, the patient experienced STOMATITIS (Mouth sores occasionally) and FEELING GUILTY (Guilt feeling). At the time of the report, STOMATITIS (Mouth sores occasionally) outcome was unknown and CANDIDA INFECTION (Had thrush following vaccine) and FEELING GUILTY (Guilt feeling) was resolving.            The concomitant medication was not reported by reporter. It was reported that patient experienced guilt feeling of losing husband after placing him into hospice care and assisted living home. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: was itchy; injection site reaction/area swelled; sore arm; low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (was itchy), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) in a 21-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 Plaque psoriasis.    No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE PRURITUS (was itchy) and INJECTION SITE SWELLING (injection site reaction/area swelled). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (was itchy) was resolving, PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and INJECTION SITE SWELLING (injection site reaction/area swelled) had resolved.            Concomitant medication was not reported.   The patient had injection site reaction area swelled to around 3 cm and was itchy. She did take Benedryl and that helped some with the itchiness and it was no longer swollen. 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: was itchy; injection site reaction/area swelled; sore arm; low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (was itchy), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) in a 21-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 Plaque psoriasis.    No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE PRURITUS (was itchy) and INJECTION SITE SWELLING (injection site reaction/area swelled). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (was itchy) was resolving, PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and INJECTION SITE SWELLING (injection site reaction/area swelled) had resolved.            Concomitant medication was not reported.   The patient had injection site reaction area swelled to around 3 cm and was itchy. She did take Benedryl and that helped some with the itchiness and it was no longer swollen. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over arms) 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 Psoriasis vulgaris.    No Medical History information was reported.   In January 2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 75 milligram twice a day. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced RASH (Rash over arms). At the time of the report, RASH (Rash over arms) was resolving.            It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chills, Headache, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Pain of extremities; Painful joints; Swelling of limbs; Rib pain; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain of extremities), ARTHRALGIA (Painful joints), PERIPHERAL SWELLING (Swelling of limbs), MUSCULOSKELETAL CHEST PAIN (Rib pain) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain of extremities), ARTHRALGIA (Painful joints), PERIPHERAL SWELLING (Swelling of limbs), MUSCULOSKELETAL CHEST PAIN (Rib pain), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Pain of extremities) was resolving, ARTHRALGIA (Painful joints), HEADACHE (Headache) and CHILLS (Chills) had resolved, PERIPHERAL SWELLING (Swelling of limbs) had not resolved and MUSCULOSKELETAL CHEST PAIN (Rib pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine was reported. No medical history was reported. On unknown dates, the patient experienced soreness in feet and hands sometimes in knees and hips, middle toe was swollen, rib cage pain, headache and chills. It was unknown if patient was enrolled in a covid-19 vaccine trial. For Humira, the reporter causality for the event soreness in feet and hands sometimes in knees and hips unknown onset and soreness in feet and hands sometimes in knees and hips unknown onset, middle toe was swollen, rib cage pain, headache and chills 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. No treatment medicine was reported.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling
Clinical narrative: Pain of extremities; Painful joints; Swelling of limbs; Rib pain; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain of extremities), ARTHRALGIA (Painful joints), PERIPHERAL SWELLING (Swelling of limbs), MUSCULOSKELETAL CHEST PAIN (Rib pain) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain of extremities), ARTHRALGIA (Painful joints), PERIPHERAL SWELLING (Swelling of limbs), MUSCULOSKELETAL CHEST PAIN (Rib pain), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Pain of extremities) was resolving, ARTHRALGIA (Painful joints), HEADACHE (Headache) and CHILLS (Chills) had resolved, PERIPHERAL SWELLING (Swelling of limbs) had not resolved and MUSCULOSKELETAL CHEST PAIN (Rib pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine was reported. No medical history was reported. On unknown dates, the patient experienced soreness in feet and hands sometimes in knees and hips, middle toe was swollen, rib cage pain, headache and chills. It was unknown if patient was enrolled in a covid-19 vaccine trial. For Humira, the reporter causality for the event soreness in feet and hands sometimes in knees and hips unknown onset and soreness in feet and hands sometimes in knees and hips unknown onset, middle toe was swollen, rib cage pain, headache and chills 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. No treatment medicine was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Hypophagia, Illness, Speech disorder, Vomiting
Clinical narrative: Oral intake reduced; Diarrhea; Vomiting; Sickness; Speech disorder; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), SPEECH DISORDER (Speech disorder), HYPOPHAGIA (Oral intake reduced), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced ILLNESS (Sickness), SPEECH DISORDER (Speech disorder), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced HYPOPHAGIA (Oral intake reduced). At the time of the report, ILLNESS (Sickness), SPEECH DISORDER (Speech disorder), HYPOPHAGIA (Oral intake reduced), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved.            No concomitant and 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Skin infection, Vaccination site pain
Clinical narrative: localized skin infections; Swollen lymph nodes/swelled lymph nodes; Chills; Site of vaccination painful/local sore arm where COVID-19 vaccine injected; This spontaneous case was reported by a consumer and describes the occurrence of SKIN INFECTION (localized skin infections), LYMPHADENOPATHY (Swollen lymph nodes/swelled lymph nodes), CHILLS (Chills) and VACCINATION SITE PAIN (Site of vaccination painful/local sore arm where COVID-19 vaccine injected) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced CHILLS (Chills) and VACCINATION SITE PAIN (Site of vaccination painful/local sore arm where COVID-19 vaccine injected). On an unknown date, the patient experienced SKIN INFECTION (localized skin infections) and LYMPHADENOPATHY (Swollen lymph nodes/swelled lymph nodes). At the time of the report, SKIN INFECTION (localized skin infections) and LYMPHADENOPATHY (Swollen lymph nodes/swelled lymph nodes) had not resolved and CHILLS (Chills) and VACCINATION SITE PAIN (Site of vaccination painful/local sore arm where COVID-19 vaccine injected) was resolving.            Concomitant product use was not provided by the reporter. The patient had localized skin infections and swelled Lymph nodes causing by SKYRIZI. This had happened three times already so they were switching her. Patient had to be taken off SKYRIZI & switching her to Tremfia. After covid-19 vaccine she had chills and local sore arm where injected. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of LOCALIZED SKIN INFECTIONS and SWELLED LYMPH NODES with  SKYRIZI(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event(s) of CHILLS and LOCAL SORE ARM WHERE COVID-19 VACCINE INJECTED with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back disorder, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Back issues; Patient had all three vaccinations/just pain in arm; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Back issues), VACCINATION SITE PAIN (Patient had all three vaccinations/just pain in arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 44-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.    No Medical History information was reported.   On 10-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. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 18-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced BACK DISORDER (Back issues) and VACCINATION SITE PAIN (Patient had all three vaccinations/just pain in arm). At the time of the report, BACK DISORDER (Back issues) had not resolved and VACCINATION SITE PAIN (Patient had all three vaccinations/just pain in arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and HEADACHE (Headache) in a 52-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.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Pain) and HEADACHE (Headache). At the time of the report, PAIN (Pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Pain
Clinical narrative: Pain from fibromyalgia; Sore body; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Pain from fibromyalgia) and PAIN (Sore body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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) Citrate free. In April 2021, the patient experienced PAIN (Sore body). On an unknown date, the patient experienced FIBROMYALGIA (Pain from fibromyalgia). In 2021, PAIN (Sore body) had resolved. At the time of the report, FIBROMYALGIA (Pain from fibromyalgia) had not resolved.            No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622971 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Vaccination site pain/sore arm; Foot pain/PAIN IN ARCH OF LEFT FOOT; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain/sore arm) and PAIN IN EXTREMITY (Foot pain/PAIN IN ARCH OF LEFT FOOT) 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 ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    The patient's past medical history included Shoulder operation (On 19 Feb 2021, the patient experienced LEFT SHOULDER SURGERY. In 2021, the LEFT SHOULDER SURGERY resolved.) from 19-Feb-2021 to 2021. Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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) UNK, Citrate Free. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/sore arm) and PAIN IN EXTREMITY (Foot pain/PAIN IN ARCH OF LEFT FOOT). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain/sore arm) outcome was unknown and PAIN IN EXTREMITY (Foot pain/PAIN IN ARCH OF LEFT FOOT) had not resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Formulation of Humira was reported as 40 Milligram, Solution for injection in pre-filled pen.  No treatment medication information was provided.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporter's causality for the event(s) of LEFT SHOULDER SURGERY, SORE ARM AFTER SECOND COVID VACCINE and PAIN IN ARCH OF LEFT FOOT with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of LEFT SHOULDER SURGERY, SORE ARM AFTER SECOND COVID VACCINE and PAIN IN ARCH OF LEFT FOOT are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  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 17-Dec-2021: Live Significant Follow-up appended: patient demographics, suspect drug information and narrative updated
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiffness; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (fever), CHILLS and HEADACHE in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HUMIRA solution for injection for Arthritis.    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. and ADALIMUMAB (HUMIRA) (Subcutaneous) Discontinued. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) had resolved.            No concomitant and 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.