chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Memory impairment, Mouth swelling, Obesity
Clinical narrative: Forgetful occasionally; chemical or abrasion irritation of skin; Obesity; Swollen mouth; Feet burning; Body itching; Rash; Chills; fever/high temperature; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Forgetful occasionally), SKIN IRRITATION (chemical or abrasion irritation of skin), OBESITY (Obesity), MOUTH SWELLING (Swollen mouth) and BURNING SENSATION (Feet burning) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Tick bite. Concurrent medical conditions included Crohn's disease and Diabetes.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2021, the patient experienced PYREXIA (fever/high temperature). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Forgetful occasionally), SKIN IRRITATION (chemical or abrasion irritation of skin), OBESITY (Obesity), MOUTH SWELLING (Swollen mouth), BURNING SENSATION (Feet burning), PRURITUS (Body itching), RASH (Rash) and CHILLS (Chills). At the time of the report, MEMORY IMPAIRMENT (Forgetful occasionally), RASH (Rash), PYREXIA (fever/high temperature) and CHILLS (Chills) outcome was unknown and SKIN IRRITATION (chemical or abrasion irritation of skin), OBESITY (Obesity), MOUTH SWELLING (Swollen mouth), BURNING SENSATION (Feet burning) and PRURITUS (Body itching) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Typhus rickettsia test: (Positive) Positive.         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(s) of tick bite, forgetful occasionally, diabetes, obesity, chills, swollen mouth, feet burning, body itching, fever/high temperature, rash and positive for spotted tick fever was not provided. The reporter's causality for the event(s) of chemical or abrasion irritation of skin with Humira (adalimumab) was no reasonable possibility. Reporter assessed events of tick bite, forgetful occasionally, diabetes, obesity, chills, swollen mouth, feet burning, body itching, fever/high temperature, rash and positive for spotted tick fever and chemical or abrasion irritation of skin as possibly related to Moderna Covid-19 vaccine.  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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Skin irritation, Typhus rickettsia test
Clinical narrative: Forgetful occasionally; chemical or abrasion irritation of skin; Obesity; Swollen mouth; Feet burning; Body itching; Rash; Chills; fever/high temperature; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Forgetful occasionally), SKIN IRRITATION (chemical or abrasion irritation of skin), OBESITY (Obesity), MOUTH SWELLING (Swollen mouth) and BURNING SENSATION (Feet burning) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Tick bite. Concurrent medical conditions included Crohn's disease and Diabetes.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2021, the patient experienced PYREXIA (fever/high temperature). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Forgetful occasionally), SKIN IRRITATION (chemical or abrasion irritation of skin), OBESITY (Obesity), MOUTH SWELLING (Swollen mouth), BURNING SENSATION (Feet burning), PRURITUS (Body itching), RASH (Rash) and CHILLS (Chills). At the time of the report, MEMORY IMPAIRMENT (Forgetful occasionally), RASH (Rash), PYREXIA (fever/high temperature) and CHILLS (Chills) outcome was unknown and SKIN IRRITATION (chemical or abrasion irritation of skin), OBESITY (Obesity), MOUTH SWELLING (Swollen mouth), BURNING SENSATION (Feet burning) and PRURITUS (Body itching) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Typhus rickettsia test: (Positive) Positive.         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(s) of tick bite, forgetful occasionally, diabetes, obesity, chills, swollen mouth, feet burning, body itching, fever/high temperature, rash and positive for spotted tick fever was not provided. The reporter's causality for the event(s) of chemical or abrasion irritation of skin with Humira (adalimumab) was no reasonable possibility. Reporter assessed events of tick bite, forgetful occasionally, diabetes, obesity, chills, swollen mouth, feet burning, body itching, fever/high temperature, rash and positive for spotted tick fever and chemical or abrasion irritation of skin as possibly related to Moderna Covid-19 vaccine.  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.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Headache
Clinical narrative: Pain in shoulders; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and ARTHRALGIA (Pain in shoulders) in a 75-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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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 January 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ARTHRALGIA (Pain in shoulders). In 2021, HEADACHE (Headache) had resolved. At the time of the report, ARTHRALGIA (Pain in shoulders) had resolved.            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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 36-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 Ulcerative colitis.    No Medical History information was reported.   On 24-Oct-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) Solution for injection in pre-filled pen. On 24-Oct-2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 vaccine Trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fall
Clinical narrative: SLIPPED IN THE SHOWER; This spontaneous case was reported by a consumer and describes the occurrence of FALL (SLIPPED IN THE SHOWER) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FALL (SLIPPED IN THE SHOWER). In 2021, FALL (SLIPPED IN THE SHOWER) had resolved.            No concomitant medication was reported. In 2021, the patient experienced SLIPPED IN THE SHOWER. In 2021, the SLIPPED IN THE SHOWER resolved.  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 SLIPPED IN THE SHOWER with HUMIRA(ADALIMUMAB) was a reasonable possibility.   This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Fatigue, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Inappropriate schedule of vaccine administered; COVID-19; Fatigue aggravated; Arthralgia aggravated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FATIGUE (Fatigue aggravated), ARTHRALGIA (Arthralgia aggravated) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 63-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 Drug allergy (PLAQUENIL) and Drug allergy (REGLAN). Concomitant products included VITAMIN D3 and CALCIUM, COLECALCIFEROL (CALCIUM 500+D) for an unknown indication.   In September 2019, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram. On 31-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. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 5 milligram. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 7.5 milligram. In June 2021, the patient experienced COVID-19 (COVID-19). In 2021, the patient experienced FATIGUE (Fatigue aggravated) and ARTHRALGIA (Arthralgia aggravated). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, FATIGUE (Fatigue aggravated) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and ARTHRALGIA (Arthralgia aggravated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, SARS-CoV-2 test: (Positive) Positive.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication was provided. The reporter's causality of rinvoq for the events of COVID-19, More fatigue increase joint pain, patient afraid would run out of rinvoq prior receiving and spacing out pills to one pill every other day to every three days was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Pain in arm; ARM WAS SORE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and LIMB DISCOMFORT (ARM WAS SORE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    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 IN EXTREMITY (Pain in arm) and LIMB DISCOMFORT (ARM WAS SORE). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and LIMB DISCOMFORT (ARM WAS SORE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment drug was 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: F
Vaccine: COVID19
Symptoms: Brain neoplasm, Death
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEATH (she passed away) and BRAIN NEOPLASM (Brain Tumor) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (she passed away) (seriousness criteria death and medically significant) and BRAIN NEOPLASM (Brain Tumor) (seriousness criterion medically significant). The patient died on 10-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, BRAIN NEOPLASM (Brain Tumor) outcome was unknown. Concomitant medications were not reported. 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. Company comment: This is a spontaneous case reported by a consumer. A female patient of an unknown age, with no reported medical history, died after receiving second dose of mRNA-1273 vaccine. Within weeks of her second vaccine, she started not acting right, she got sick so fast and then passed away on 10-Sep-2021. It was also reported that within days of her getting the second vaccine, she was falling down. In addition, patient was diagnosed with a brain tumor on an unknown date. Vaccination date was not provided, latency cannot be assessed. The cause of death was not reported. It is unknown if an autopsy was performed. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a consumer. A female patient of an unknown age, with no reported medical history, died after receiving second dose of mRNA-1273 vaccine. Within weeks of her second vaccine, she started not acting right, she got sick so fast and then passed away on 10-Sep-2021. It was also reported that within days of her getting the second vaccine, she was falling down. In addition, patient was diagnosed with a brain tumor on an unknown date. Vaccination date was not provided, latency cannot be assessed. The cause of death was not reported. It is unknown if an autopsy was performed. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) 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 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) Citrate free. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The reporter's causality for the event of swollen arm with humira(adalimumab) was no reasonable  Possibility.  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.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Waldenstrom's macroglobulinemia.  No known allergies reported. Concurrent medical conditions included Fatigue.  On 17-Sep-1921, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 280 milligram once a day. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram once a day. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had not resolved.  No concomitant medication details were provided. No treatment medication details were provided.  Primary reporter contact for lot number information was not available.  The reporter's causality for the event of fatigue was not provided with IBRUTINIB (IMBRUVICA).  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: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chills, Malaise
Clinical narrative: Did not feel good and joint pains getting a lot worse in the shoulders; Did not feel good; Feeling sick; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), MALAISE (Did not feel good), ARTHRALGIA (Did not feel good and joint pains getting a lot worse in the shoulders) and CHILLS (Chills) in a 62-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.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 30-Aug-2021, the patient experienced MALAISE (Feeling sick) and CHILLS (Chills). On 31-Aug-2021, the patient experienced MALAISE (Did not feel good). On an unknown date, the patient experienced ARTHRALGIA (Did not feel good and joint pains getting a lot worse in the shoulders). In 2021, MALAISE (Did not feel good) and CHILLS (Chills) had resolved. On 30-Aug-2021, MALAISE (Feeling sick) had resolved. At the time of the report, ARTHRALGIA (Did not feel good and joint pains getting a lot worse in the shoulders) had not resolved.            No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Laboratory test, Vaccination site pain
Clinical narrative: UPPER GASTROINTESTINAL ISSUES; SORE ARM AFTER COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (UPPER GASTROINTESTINAL ISSUES) and VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE) 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 Ulcerative colitis.    Concurrent medical conditions included Visual impairment and Ulcerative colitis.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose once a week. 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 GASTROINTESTINAL DISORDER (UPPER GASTROINTESTINAL ISSUES) and VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE). At the time of the report, GASTROINTESTINAL DISORDER (UPPER GASTROINTESTINAL ISSUES) and VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Result elevated.         No relevant concomitant medications were reported.   The reporter's causality for the events of upper gastrointestinal issues, sore arm after covid vaccine with humira 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 mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Got break through cases; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (Got break through cases) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (Got break through cases). At the time of the report, BREAKTHROUGH COVID-19 (Got break through cases) outcome was unknown. Not Provided          No concomitant medications were reported.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the adverse event of special interest of breakthrough COVID-19 an unknown time after a dose of mRNA-1273. Information regarding vaccine schedule, clinical evaluation, diagnostic tests, and treatment provided has not been disclosed. Outcome was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the adverse event of special interest of breakthrough COVID-19 an unknown time after a dose of mRNA-1273. Information regarding vaccine schedule, clinical evaluation, diagnostic tests, and treatment provided has not been disclosed. Outcome was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: Psoriasis aggravated/increase in psoriasis/ scales and cracks; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis aggravated/increase in psoriasis/ scales and cracks) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    There was no reported medical history.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PSORIASIS (Psoriasis aggravated/increase in psoriasis/ scales and cracks). At the time of the report, PSORIASIS (Psoriasis aggravated/increase in psoriasis/ scales and cracks) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication details were provided. No treatment medication details were provided.   Patient reported an increase in psoriasis following Moderna Covid vaccine.   The reporter's causality for the event of psoriasis was not provided with SKYRIZI (RISANKIZUMAB).  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: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug hypersensitivity
Clinical narrative: ALLERGIC TO HUMIRA; This spontaneous case was reported by a consumer and describes the occurrence of DRUG HYPERSENSITIVITY (ALLERGIC TO HUMIRA) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Idiopathic urticaria, Generalized osteoarthritis and Pancolitis.    No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced DRUG HYPERSENSITIVITY (ALLERGIC TO HUMIRA). At the time of the report, DRUG HYPERSENSITIVITY (ALLERGIC TO HUMIRA) was resolving.            No relevant concomitant medications were reported.   The reporter's causality for the event of ALLERGIC TO HUMIRA with HUMIRA(ADALIMUMAB) was no reasonable possibility.  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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Significant follow up received included event verbatim updated.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Illness
Clinical narrative: Joint pain; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) and ILLNESS (Sickness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Joint pain) and ILLNESS (Sickness). At the time of the report, ARTHRALGIA (Joint pain) had not resolved and ILLNESS (Sickness) had resolved.            No concomitant medications were reported. Adult male patient reported that his Joints had been hurting knees/hurting while going up and down stairs and feeling Sick with skyrizi (risankizumab) and might be due to cold weather. Patient was sick for 2 days after second dose of Covid-19 vaccine. 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. No treatment information was reported.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 65-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 Crohn's disease. There was no reported medical history.  On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received 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) Citrate free. In September 2021, the patient experienced VOMITING (Vomiting). In September 2021, VOMITING (Vomiting) had resolved.  No concomitant medication details were provided. No treatment medication details were provided., The reporter's causality for the event of vomiting was not provided with HUMIRA(ADALIMUMAB). 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore arm; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Joint pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   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. In October 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) Citrate free, Solution for injection in pre-filled pen. In October 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Joint pain). In October 2021, PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Joint pain) had resolved.            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, UNK
Symptoms: Pain
Clinical narrative: Pain; Pain; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of PAIN (Pain) and the first episode of PAIN (Pain) 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 Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 22-Oct-2021, the patient experienced the first episode of PAIN (Pain). On an unknown date, the patient experienced the second episode of PAIN (Pain). At the time of the report, last episode of PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of pain after the covid vaccine and pain with Humira(adalimumab) was a reasonable possibility.  Treatment Drugs Not 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: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Injection site pain
Clinical narrative: Injection site pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and INJECTION SITE PAIN (Injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate To Severe Hidradenitis Suppurativa).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,CF. In 2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, DIARRHOEA (Diarrhea) had not resolved and INJECTION SITE PAIN (Injection site pain) was resolving.            Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had burning or tender at injection site and diarrhea.  The reporter's causality for the event of Diarrhea was reported as no reasonable possibility and for Injection site pain was reported as reasonable possibility for Humira.  No treatment medication were 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: 55.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Feeling abnormal
Clinical narrative: FELT BAD; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (FELT BAD) in a 55-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) for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 20-Oct-2021, the patient received 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 pre-filled pen and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced FEELING ABNORMAL (FELT BAD). At the time of the report, FEELING ABNORMAL (FELT BAD) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of FELT BAD was not provided.  No treatment medication 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: injection site knot/nodule; Injection site itching; injection site hard; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (injection site knot/nodule), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE INDURATION (injection site hard) and INJECTION SITE ERYTHEMA (injection site red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced INJECTION SITE NODULE (injection site knot/nodule), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE INDURATION (injection site hard) and INJECTION SITE ERYTHEMA (injection site red). At the time of the report, INJECTION SITE NODULE (injection site knot/nodule) and INJECTION SITE PRURITUS (Injection site itching) was resolving and INJECTION SITE INDURATION (injection site hard) and INJECTION SITE ERYTHEMA (injection site red) had not resolved.            Concomitant medication was not reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for Humira: the event(s) of injection site knot/nodule, injection site hard, injection site red and injection site itching was not provided.  Treatment drug was not 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, COVID19
Symptoms: Antibody test, Body temperature, Head discomfort, Oropharyngeal pain, Suspected COVID-19
Clinical narrative: My head was on fire; Throat got sore; Might have had it COVID-19; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (My head was on fire), OROPHARYNGEAL PAIN (Throat got sore) and SUSPECTED COVID-19 (Might have had it COVID-19) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEAD DISCOMFORT (My head was on fire), OROPHARYNGEAL PAIN (Throat got sore) and SUSPECTED COVID-19 (Might have had it COVID-19). In March 2021, HEAD DISCOMFORT (My head was on fire), OROPHARYNGEAL PAIN (Throat got sore) and SUSPECTED COVID-19 (Might have had it COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 8/12 current result lesser that 0.8 SARS- Spike AB interp says POSITIVE. In 2021, Body temperature: 98.4 98.4 degree F.   Patient wants to know if the test result is in the high or low end and how to interpret the results. Patient had no side effects. Patient head was on fire, although he did not have a temperature and throat got sore. Patient took medication and woke up fine. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620775 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Body temperature, Vaccination site pain
Clinical narrative: My head was on fire; Throat got sore; Might have had it COVID-19; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (My head was on fire), OROPHARYNGEAL PAIN (Throat got sore) and SUSPECTED COVID-19 (Might have had it COVID-19) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEAD DISCOMFORT (My head was on fire), OROPHARYNGEAL PAIN (Throat got sore) and SUSPECTED COVID-19 (Might have had it COVID-19). In March 2021, HEAD DISCOMFORT (My head was on fire), OROPHARYNGEAL PAIN (Throat got sore) and SUSPECTED COVID-19 (Might have had it COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 8/12 current result lesser that 0.8 SARS- Spike AB interp says POSITIVE. In 2021, Body temperature: 98.4 98.4 degree F.   Patient wants to know if the test result is in the high or low end and how to interpret the results. Patient had no side effects. Patient head was on fire, although he did not have a temperature and throat got sore. Patient took medication and woke up fine. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620775 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Body temperature, Head discomfort, Oropharyngeal pain, Suspected COVID-19
Clinical narrative: The left arm got a little sore for some reason; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The left arm got a little sore for some reason) 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.  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (The left arm got a little sore for some reason). At the time of the report, VACCINATION SITE PAIN (The left arm got a little sore for some reason) outcome was unknown.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 8/12 current result lesser that 0.8 SARS- Spike AB interp says POSITIVE. In 2021, Body temperature: 98.4 98.4 degree F.  Patient wants to know if the test result is in the high or low end and how to interpret the results. Patient had no side effects. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620774 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Body temperature, Vaccination site pain
Clinical narrative: The left arm got a little sore for some reason; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The left arm got a little sore for some reason) 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.  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (The left arm got a little sore for some reason). At the time of the report, VACCINATION SITE PAIN (The left arm got a little sore for some reason) outcome was unknown.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 8/12 current result lesser that 0.8 SARS- Spike AB interp says POSITIVE. In 2021, Body temperature: 98.4 98.4 degree F.  Patient wants to know if the test result is in the high or low end and how to interpret the results. Patient had no side effects. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620774 (Patient Link).