chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carditis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Heart inflammation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDITIS (Heart inflammation) (seriousness criteria death and medically significant). An autopsy was performed. The autopsy-determined cause of death was Cardiac arrest and heart inflammation. Concomitant medication was not reported. Patient's autopsy result showed cardiac arrest from heart inflammation. Treatment details were not reported. Cardiac arrest was reported symptoms of Heart inflammation. 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 an unknown age with no reported medical history, who experienced the unexpected, serious (fatal) adverse event of special interest Carditis (Heart inflammation) on an unknown date in the context of having received a dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and event onset were undisclosed. Treatment and laboratory details were not reported. The event led to a fatal outcome on an unknown date. It was reported that  autopsy result showed cardiac arrest and heart inflammation as the cause of death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious (fatal) adverse event of special interest Carditis (Heart inflammation) on an unknown date in the context of having received a dose of mRNA-1273 vaccine. Onset latency could not be determined as dates of vaccination and event onset were undisclosed. Treatment and laboratory details were not reported. The event led to a fatal outcome on an unknown date. It was reported that autopsy result showed cardiac arrest and heart inflammation as the cause of death. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Autopsy-determined Cause(s) of Death: Cardiac arrest; Heart inflammation.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021; Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021; Interchange of vaccine products; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), COVID-19 IMMUNISATION (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 EXTRA DOSE ADMINISTERED (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), COVID-19 IMMUNISATION (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), COVID-19 IMMUNISATION (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was provided. No treatment medication was provided. The patient was completed primary series of Pfizer Covid 19 vaccine on 8-Mar-2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021.
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: Crohn's; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's) 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 Crohn's disease.    The patient's past medical history included Crohn's disease (In 2019, the patient was in the hospital due to Chrohn's. She was recovered from hospitalization).   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 CROHN'S DISEASE (Crohn's) (seriousness criteria hospitalization and medically significant). At the time of the report, CROHN'S DISEASE (Crohn's) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was recovered from hospitalization. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.  Company Comment:  This spontaneous case concerns an elderly female patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (hospitalization and medically significant) event of Crohn's disease on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and onset date of the event was not provided. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to recur. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with relevant medical history of Crohn's disease, who experienced the unexpected, serious  (hospitalization and medically significant) event of Crohn's disease on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and onset date of the event was not provided. No information on any other doses of COVID-19 vaccination was provided. The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to recur. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FELT TIRED/ Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (FELT TIRED/ Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (FELT TIRED/ Tiredness). At the time of the report, FATIGUE (FELT TIRED/ Tiredness) was resolving.            Patient's husband had cancer. Relevant concomitant medications were not reported.  On unknown date, the patient took second shot of Moderna COVID-19 Vaccine and felt arm hurt. On unknown date, the patient took booster dose of Moderna COVID-19 Vaccine and felt tired.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623797.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       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 provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2021-623784, MOD-2021-623786 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Liver function test, Skin disorder
Clinical narrative: Skin disorder/Feels like scalp got worse and had spots on back; Joint pain/Pain in joints; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Skin disorder/Feels like scalp got worse and had spots on back), ARTHRALGIA (Joint pain/Pain in joints) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    No Medical History information was reported.   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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (Skin disorder/Feels like scalp got worse and had spots on back), ARTHRALGIA (Joint pain/Pain in joints) and HEADACHE (Headache). At the time of the report, SKIN DISORDER (Skin disorder/Feels like scalp got worse and had spots on back) and ARTHRALGIA (Joint pain/Pain in joints) had not resolved and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Liver function test: doubled..         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 provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2021-623781, MOD-2021-623786 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; first dose of Moderna Covid vaccine on 8Mar2021, and then received a dose of Pfizer BioNTech Covid 19 vaccine on 14Jul2021; interchange of vaccine products; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (No adverse event), COVID-19 IMMUNISATION (first dose of Moderna Covid vaccine on 8Mar2021, and then received a dose of Pfizer BioNTech Covid 19 vaccine on 14Jul2021) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced COVID-19 IMMUNISATION (first dose of Moderna Covid vaccine on 8Mar2021, and then received a dose of Pfizer BioNTech Covid 19 vaccine on 14Jul2021) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event), COVID-19 IMMUNISATION (first dose of Moderna Covid vaccine on 8Mar2021, and then received a dose of Pfizer BioNTech Covid 19 vaccine on 14Jul2021) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (first dose of Moderna Covid vaccine on 8Mar2021, and then received a dose of Pfizer BioNTech Covid 19 vaccine on 14Jul2021) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products).    Concomitant products were not provided. Treatment medication were 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sneezing
Clinical narrative: Sneezing; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis and Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third 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 SNEEZING (Sneezing) and HEADACHE (Headache). At the time of the report, SNEEZING (Sneezing) and HEADACHE (Headache) had resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided.  No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2021-623781, MOD-2021-623784, MOD-2021-623781 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paralysis
Clinical narrative: paresthesia; paralysis; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (paresthesia) and PARALYSIS (paralysis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 PARAESTHESIA (paresthesia) (seriousness criterion hospitalization) and PARALYSIS (paralysis) (seriousness criteria hospitalization and medically significant). At the time of the report, PARAESTHESIA (paresthesia) and PARALYSIS (paralysis) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient was hospitalized for a month and had weeks of physical therapy. 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, received 2 doses of mRNA-1273 vaccine in March 2021 and experienced serious events of paraesthesia and paralysis from the chest  down in April 2021 which lead to a month-long hospital stay and weeks of physical therapy. No further details regarding clinical course, diagnostic tests or treatment performed 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, received 2 doses of mRNA-1273 vaccine in March 2021 and experienced serious events of paraesthesia and paralysis from the chest  down in April 2021 which lead t a month-long hospital stay and weeks of physical therapy. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: SECOND SHOT OF COVID IN ARM HURT/ Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SECOND SHOT OF COVID IN ARM HURT/ Vaccination site pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second 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 VACCINATION SITE PAIN (SECOND SHOT OF COVID IN ARM HURT/ Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (SECOND SHOT OF COVID IN ARM HURT/ Vaccination site pain) was resolving.            Patient's husband had cancer. Relevant concomitant medications were not reported.  On unknown dates, the patient took second shot of Moderna COVID-19 Vaccine and felt arm hurt.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623780 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: got achy and that lasted a few hours and he was past it.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (got achy and that lasted a few hours and he was past it.) 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 (got achy and that lasted a few hours and he was past it.). At the time of the report, PAIN (got achy and that lasted a few hours and he was past it.) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Exposure to SARS-CoV-2, Headache, Muscular weakness, Nausea, SARS-CoV-2 test
Clinical narrative: Blurred vision; Muscle weakness; Nausea; headache; Exposure to COVID-19 by family; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea), HEADACHE (headache) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19 by family) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 18-May-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19 by family). On 12-Aug-2021, the patient experienced VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea) and HEADACHE (headache). At the time of the report, VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea) and HEADACHE (headache) was resolving and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19 by family) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The patient was exposed to Covid-19 by family in his home around 23-Jul-2021. Patient did move to hotel and self-quarantine. The patient was feeling better however, still unable to work. No other information reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the event of blurred vision, muscle weakness, exposed to covid-19 by family, nausea and headache was not provided for co-suspect drug Skyrizi.
Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vision blurred
Clinical narrative: Blurred vision; Muscle weakness; Nausea; headache; Exposure to COVID-19 by family; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea), HEADACHE (headache) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19 by family) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 18-May-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19 by family). On 12-Aug-2021, the patient experienced VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea) and HEADACHE (headache). At the time of the report, VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea) and HEADACHE (headache) was resolving and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19 by family) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The patient was exposed to Covid-19 by family in his home around 23-Jul-2021. Patient did move to hotel and self-quarantine. The patient was feeling better however, still unable to work. No other information reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the event of blurred vision, muscle weakness, exposed to covid-19 by family, nausea and headache was not provided for co-suspect drug Skyrizi.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Feeling abnormal, Sinusitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), SINUSITIS (Sinus infection), ARTHRALGIA (Shoulder pain) and FEELING ABNORMAL (Foggy feeling in head) 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 Psoriatic plaque.    No Medical History information was reported.   On 30-May-2021, the patient received first 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. On an unknown date, the patient experienced COVID-19 (COVID-19), SINUSITIS (Sinus infection), ARTHRALGIA (Shoulder pain) and FEELING ABNORMAL (Foggy feeling in head). At the time of the report, COVID-19 (COVID-19) and SINUSITIS (Sinus infection) was resolving, ARTHRALGIA (Shoulder pain) had resolved and FEELING ABNORMAL (Foggy feeling in head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant or treatment medication provided
Sex: F
Vaccine: COVID19
Symptoms: Varicella
Clinical narrative: Chickenpox; This spontaneous case was reported by a consumer and describes the occurrence of VARICELLA (Chickenpox) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VARICELLA (Chickenpox). At the time of the report, VARICELLA (Chickenpox) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported. People that had COVID after vaccine they seem to had more side effects especially with moderna. Also lady never had chicken pox as kid and now had chicken pox since april and doctor said they may never go away.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Among those who received two dose moderna vaccine 72 died of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Among those who received two dose moderna vaccine 72 died of COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Among those who received two dose moderna vaccine 72 died of COVID-19) (seriousness criteria death and hospitalization). The reported cause of death was among those who received two dose moderna vaccine 72 died of covid-19. It is unknown if an autopsy was performed. Not Provided          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.  Company comment.  This fatal spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of COVID-19. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of COVID-19. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. The benefit risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Among those who received two dose moderna vaccine 72 died of COVID-19
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Eczema, Oral herpes
Clinical narrative: Cold sores in mouth have appeared; Flare ups on face; Eczema flares, have been in a cycle of clearing and rebounding; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema flares, have been in a cycle of clearing and rebounding), DERMATITIS ATOPIC (Flare ups on face) and ORAL HERPES (Cold sores in mouth have appeared) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concomitant products included FLUCONAZOLE for an unknown indication.   In December 2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced ECZEMA (Eczema flares, have been in a cycle of clearing and rebounding). In May 2021, the patient experienced DERMATITIS ATOPIC (Flare ups on face). On an unknown date, the patient experienced ORAL HERPES (Cold sores in mouth have appeared). The patient was treated with KETOCONAZOLE (topical) for Dermatitis atopic, at an unspecified dose and frequency; PREDNISONE for Eczema, at an unspecified dose and frequency; ACYCLOVIR [ACICLOVIR] for Cold sore mouth, at a dose of 5 days and FLUCONAZOLE for Eczema, at a dose of UNK, qwk. At the time of the report, ECZEMA (Eczema flares, have been in a cycle of clearing and rebounding) and DERMATITIS ATOPIC (Flare ups on face) outcome was unknown and ORAL HERPES (Cold sores in mouth have appeared) was resolving.            Patient's dermatologist told her to put ketoconazole shampoo over the face which did not help much. Last month the patient was prescribed fluconazole once a week. Patient states the flare ups are not as bad as what her condition was prior to beginning dupixent.  Other treatment medications included Protopics, antifungals,but none were tolerable. Cold sores in mouth have appeared about a month ago. Was treated with 5 days of acyclovir, helped but total remission was not achieved.  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-2021-623823 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st Moderna COVID shot on 2/6/21/ and 2nd shot was administered on 11/19/21; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna COVID shot on 2/6/21/ and 2nd shot was administered on 11/19/21) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concomitant products included FLUCONAZOLE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, 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 started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 19-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna COVID shot on 2/6/21/ and 2nd shot was administered on 11/19/21). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna COVID shot on 2/6/21/ and 2nd shot was administered on 11/19/21) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623820 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Hand deformity, Headache, Pain
Clinical narrative: Hands started deforming/Hand deformity; Pain in eyes/Eyes were hurting; General body pain/Pain in body; Joint pain/Joint pain in hands, elbows, wrist, toes and spine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HAND DEFORMITY (Hands started deforming/Hand deformity), EYE PAIN (Pain in eyes/Eyes were hurting), PAIN (General body pain/Pain in body), ARTHRALGIA (Joint pain/Joint pain in hands, elbows, wrist, toes and spine) and HEADACHE (Headache) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concomitant products included PREGABALIN (LYRICA) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form, first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. On an unknown date, the patient experienced HAND DEFORMITY (Hands started deforming/Hand deformity), EYE PAIN (Pain in eyes/Eyes were hurting), PAIN (General body pain/Pain in body), ARTHRALGIA (Joint pain/Joint pain in hands, elbows, wrist, toes and spine) and HEADACHE (Headache). At the time of the report, HAND DEFORMITY (Hands started deforming/Hand deformity) outcome was unknown, EYE PAIN (Pain in eyes/Eyes were hurting), PAIN (General body pain/Pain in body) and HEADACHE (Headache) had resolved and ARTHRALGIA (Joint pain/Joint pain in hands, elbows, wrist, toes and spine) had not resolved.            No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality for the event(s) of joint pain in hands, elbows, wrist, toes and spine, headache, eyes were hurting and pain in body with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of hands started deforming 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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Live Follow up: Added suspect and Co-Suspect product information and event (Hand deformity) was added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Feeling abnormal
Clinical narrative: COVID-19 pneumonia; Foggy feeling in head; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   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, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 25-Jul-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Foggy feeling in head). At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) was resolving and FEELING ABNORMAL (Foggy feeling in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  Company Comment: This is a spontaneous case concerning a 57-year-old female patient with no relevant medical history, who experienced the unexpected, serious (hospitalization and medically significant) adverse event of special interest of COVID-19 pneumonia, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, clinical course and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 57-year-old female patient with no relevant medical history, who experienced the unexpected, serious (hospitalization and medically significant) adverse event of special interest of COVID-19 pneumonia, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, clinical course and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: His head doesn't feel right, like he's in the twilight zone; Slight rash on his face; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (His head doesn't feel right, like he's in the twilight zone) and RASH (Slight rash on his face) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (His head doesn't feel right, like he's in the twilight zone) and RASH (Slight rash on his face). At the time of the report, FEELING ABNORMAL (His head doesn't feel right, like he's in the twilight zone) and RASH (Slight rash on his face) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal mass, Computerised tomogram, Immunisation reaction, Influenza, SARS-CoV-2 test
Clinical narrative: Adrenal nodule; Flu; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), ADRENAL MASS (Adrenal nodule) and IMMUNISATION REACTION (Vaccination adverse reaction) 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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). In September 2021, the patient experienced INFLUENZA (Flu). On an unknown date, the patient experienced ADRENAL MASS (Adrenal nodule). In 2021, IMMUNISATION REACTION (Vaccination adverse reaction) had resolved. At the time of the report, INFLUENZA (Flu) and ADRENAL MASS (Adrenal nodule) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: Negative. On an unknown date, Computerised tomogram: Adrenal nodule.         Concomitant products were not provided. Treatment medication were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Psoriasis, Vaccination site pain
Clinical narrative: LITTLE DEPRESSED; PSORIASIS FLARE UP IN NOSE/HANDS/FEET; SORE ARM FROM COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (LITTLE DEPRESSED), PSORIASIS (PSORIASIS FLARE UP IN NOSE/HANDS/FEET) and VACCINATION SITE PAIN (SORE ARM FROM COVID VACCINE) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Alcohol use.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM FROM COVID VACCINE). On an unknown date, the patient experienced DEPRESSED MOOD (LITTLE DEPRESSED) and PSORIASIS (PSORIASIS FLARE UP IN NOSE/HANDS/FEET). In 2021, VACCINATION SITE PAIN (SORE ARM FROM COVID VACCINE) had resolved. At the time of the report, DEPRESSED MOOD (LITTLE DEPRESSED) and PSORIASIS (PSORIASIS FLARE UP IN NOSE/HANDS/FEET) was resolving.            Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastric disorder, Pain in extremity, Respiratory disorder
Clinical narrative: STOMACH PROBLEMS; BREATHING PROBLEMS; SORE ARM; DIARRHEA; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC DISORDER (STOMACH PROBLEMS), RESPIRATORY DISORDER (BREATHING PROBLEMS), PAIN IN EXTREMITY (SORE ARM) and DIARRHOEA (DIARRHEA) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-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) 1 dosage form. In 2021, the patient experienced GASTRIC DISORDER (STOMACH PROBLEMS), RESPIRATORY DISORDER (BREATHING PROBLEMS), PAIN IN EXTREMITY (SORE ARM) and DIARRHOEA (DIARRHEA). At the time of the report, GASTRIC DISORDER (STOMACH PROBLEMS), RESPIRATORY DISORDER (BREATHING PROBLEMS), PAIN IN EXTREMITY (SORE ARM) and DIARRHOEA (DIARRHEA) was resolving.            No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provided any causality for the events with Humira and for the event of diarrhea with Moderna vaccine.  The reporter assessed the events of gastric disorder, respiratory disorder and pain in arm possibly related to the Moderna vaccine.  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-2021-623852 (Patient Link).