chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Emotional distress, Fatigue, Headache
Clinical narrative: Emotional distress; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (Emotional distress), HEADACHE (Headache) and FATIGUE (Tiredness) in a 19-year-old male patient who received mRNA-1273 for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 07-Feb-2022, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2022, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On an unknown date, the patient experienced EMOTIONAL DISTRESS (Emotional distress). In February 2022, HEADACHE (Headache) and FATIGUE (Tiredness) had resolved. At the time of the report, EMOTIONAL DISTRESS (Emotional distress) had not resolved.        The action taken with mRNA-1273  (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient reported not feeling well emotionally. In FEB2022, patient experienced a headache and felt tired but that resolved.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Nerve injury
Clinical narrative: Chronic insomnia; Nerve damage; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Chronic insomnia) and NERVE INJURY (Nerve damage) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (2 weeks after 2nd dose) and Pfizer (1st dose). Past adverse reactions to the above products included DVT with Pfizer; and Fibrin D dimer increased with Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Chronic insomnia) and NERVE INJURY (Nerve damage). At the time of the report, INSOMNIA (Chronic insomnia) and NERVE INJURY (Nerve damage) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Ankle fracture, Fatigue, Hypersensitivity
Clinical narrative: Allergies; Tiredness; Broken ankle; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Broken ankle), HYPERSENSITIVITY (Allergies) and FATIGUE (Tiredness) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2022, received fourth 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, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. In 2021, the patient experienced ANKLE FRACTURE (Broken ankle). In February 2022, the patient experienced FATIGUE (Tiredness). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergies). At the time of the report, ANKLE FRACTURE (Broken ankle) and HYPERSENSITIVITY (Allergies) had resolved and FATIGUE (Tiredness) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Vaccination site pain; All over body pain after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All over body pain after covid vaccine) and VACCINATION SITE PAIN (Vaccination site pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.  No Medical History information was reported.  On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In April 2021, the patient experienced PAIN (All over body pain after covid vaccine). In April 2021, PAIN (All over body pain after covid vaccine) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.     No concomitant medication information was reported. No treatment medication information was reported. Processed by medical personnel on 25-Aug-2022 This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  This case was linked to MOD-2022-624780 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Now back down 99.5 today; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Now back down 99.5 today) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Now back down 99.5 today). At the time of the report, PYREXIA (Now back down 99.5 today) was resolving.            Relevant concomitant medications were not reported.  It was reported that patient's body temperature back down 99.5 at the time report and there was no real cough. Patient received 2 shots of Moderna COVID-19 vaccine and booster from Pfizer. It was also reported that the patient was feeling really fortunate at the time of report.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fall, Inappropriate schedule of product administration, Pain
Clinical narrative: Fall; Pain; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall), PAIN (Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 64-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.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced FALL (Fall) and PAIN (Pain). At the time of the report, FALL (Fall) and PAIN (Pain) had resolved with sequelae and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient fell and experienced pain. Recovered with some sequalae. Patient took the booster dose of vaccine much after the standard time gap between the doses.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Pain, Pain in extremity, Peripheral swelling, Vaccination site bruising
Clinical narrative: Swelling of hands/ Swelling in the hands more than usual; general body pain/ pain in body; Pain in hand/ Pain in hands as a burning pain; Vaccination adverse reaction/ill effects on the left side of body; Vaccination site bruising/ bruises alot more often; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction/ill effects on the left side of body), VACCINATION SITE BRUISING (Vaccination site bruising/ bruises alot more often), PERIPHERAL SWELLING (Swelling of hands/ Swelling in the hands more than usual), PAIN (general body pain/ pain in body) and PAIN IN EXTREMITY (Pain in hand/ Pain in hands as a burning pain) in a 56-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.    Concurrent medical conditions included Psoriatic arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Citrate Free). On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK (Citrate Free). In December 2020, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction/ill effects on the left side of body) and VACCINATION SITE BRUISING (Vaccination site bruising/ bruises alot more often). In April 2022, the patient experienced PAIN (general body pain/ pain in body) and PAIN IN EXTREMITY (Pain in hand/ Pain in hands as a burning pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of hands/ Swelling in the hands more than usual). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction/ill effects on the left side of body), VACCINATION SITE BRUISING (Vaccination site bruising/ bruises alot more often) and PAIN (general body pain/ pain in body) outcome was unknown and PERIPHERAL SWELLING (Swelling of hands/ Swelling in the hands more than usual) and PAIN IN EXTREMITY (Pain in hand/ Pain in hands as a burning pain) had not resolved.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in both leg; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPOAESTHESIA (Numbness in both leg) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer Covid 19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer Covid 19 vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in both leg). At the time of the report, HYPOAESTHESIA (Numbness in both leg) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported. No treatment medications was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching) 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 Ankylosing spondylitis and Panuveitis.    The patient's past medical history included Knee arthroplasty. Concurrent medical conditions included Ankylosing spondylitis and Panuveitis.   On 01-Jan-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) 40 milligram. In February 2022, the patient experienced INJECTION SITE PRURITUS (Injection site itching). At the time of the report, INJECTION SITE PRURITUS (Injection site itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Reportedly, the patient had knee replacement in last summer and had itching on injection site for couple of months.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter causality for an event KNEE ARTHROPLASTY with the Humira was no reasonable possibility and causality for an event INJECTION SITE PRURITUS with the Humira was reasonable possibility.  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 03-Jun-2022: Live Significant Follow up information received, procedure KNEE REPLACEMENT was added and causality for event injection site itching was updated to related.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Mild arm pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild arm pain) and FATIGUE (Fatigue) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Mild arm pain) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Mild arm pain) and FATIGUE (Fatigue) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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 US-MODERNATX, INC.-MOD-2022-623799 (E2B Linked Report).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After more than 24 hours my arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After more than 24 hours my arm hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) 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 (Spikevax) (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 VACCINATION SITE PAIN (After more than 24 hours my arm hurts). At the time of the report, VACCINATION SITE PAIN (After more than 24 hours my arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Post procedural complication, Psoriasis, Skin cancer, Skin mass
Clinical narrative: Skin cancer; Psoriasis flare-up; Erythematous nodule; Post procedural complication; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (Skin cancer) in a 72-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In December 2021, the patient experienced SKIN MASS (Erythematous nodule) and POST PROCEDURAL COMPLICATION (Post procedural complication). On an unknown date, the patient experienced SKIN CANCER (Skin cancer) (seriousness criterion medically significant) and PSORIASIS (Psoriasis flare-up). At the time of the report, SKIN CANCER (Skin cancer) had not resolved, SKIN MASS (Erythematous nodule) and POST PROCEDURAL COMPLICATION (Post procedural complication) outcome was unknown and PSORIASIS (Psoriasis flare-up) was resolving.    mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications was reported.  In Aug-2021, the cancer was removed and as of Dec-2021 noticed it was still red spot and a lump on her nose, she thought there was cancer on the nose. She had a Plaque Psoriasis breakout due to coverage gap. No treatment medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 72-year-old female with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Skin cancer, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old female with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Skin cancer, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Haemolysis
Clinical narrative: Severe Hemolysis; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOLYSIS (Severe Hemolysis) in a 32-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Paroxysmal nocturnal hemoglobinuria.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (Severe Hemolysis) (seriousness criterion medically significant). At the time of the report, HAEMOLYSIS (Severe Hemolysis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Concomitant medications were not reported.  Treatment medications were not reported.  Company Comment: This spontaneous case concerns a 32-year-old, female patient with medical history of Paroxysmal Nocturnal Hemoglobinuria, who experienced the unexpected, serious (medically significant) event of haemolysis. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the vaccine induced severe hemolysis. No further details were provided. The history of Paroxysmal Nocturnal Hemoglobinuria, a rare blood disorder which occurs when part of the immune system attacks and damages the red blood cells and platelets, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 32-year-old, female patient with medical history of Paroxysmal Nocturnal Hemoglobinuria, who experienced the unexpected, serious (medically significant) event of haemolysis. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the vaccine induced severe hemolysis. No further details were provided. The history of Paroxysmal Nocturnal Hemoglobinuria, a rare blood disorder which occurs when part of the immune system attacks and damages the red blood cells and platelets, remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bipolar disorder, Dizziness, Fatigue
Clinical narrative: Dizziness; Bipolar depression; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BIPOLAR DISORDER (Bipolar depression) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Psoriasis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 75 milligram. In 2021, the patient experienced FATIGUE (Fatigue). In 2022, the patient experienced BIPOLAR DISORDER (Bipolar depression) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, BIPOLAR DISORDER (Bipolar depression) had not resolved and DIZZINESS (Dizziness) and FATIGUE (Fatigue) had resolved.            No concomitant and treatment medications were reported.  Patient had been taking only 75 milligram per every 12 weeks of SKYRIZI.  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 53-year-old female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of Bipolar disorder (Bipolar depression) on an unknown date after receiving the third dose of mRNA-1273 vaccine.  Onset latency could not be determined as exact onset date of event was not provided. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 35 days apart, with the second dose given approximately 7 months prior to current vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-623876 (Patient Link).; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of Bipolar disorder (Bipolar depression) on an unknown date after receiving the third dose of mRNA-1273 vaccine.  Onset latency could not be determined as exact onset date of event was not provided. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 35 days apart, with the second dose given approximately 7 months prior to current vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Haemolysis
Clinical narrative: Severe Hemolysis; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOLYSIS (Severe Hemolysis) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Paroxysmal nocturnal hemoglobinuria.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (Severe Hemolysis) (seriousness criterion medically significant). At the time of the report, HAEMOLYSIS (Severe Hemolysis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Concomitant medications were not reported.  Treatment medications were not reported.  CC: This spontaneous case concerns a 63-year-old, male patient with an underlying paroxysmal nocturnal hemoglobinuria, who experienced and unexpected, medically significant event of Severe hemolysis in association with a dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying paroxysmal nocturnal hemoglobinuria remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 63-year-old, male patient with an underlying paroxysmal nocturnal hemoglobinuria, who experienced and unexpected, medically significant event of Severe hemolysis in association with a dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying paroxysmal nocturnal hemoglobinuria remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced COVID-19 (covid-19) (seriousness criterion life threatening). At the time of the report, COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not 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 life - threatening spontaneous case concerns a female patient of unknown age, with no medical history provided, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of COVID-19. Vaccination date from second dose was not reported; hence latency and temporal association cannot be properly assessed. The patient tested positive for COVID  19 approximately 9 months after the first dose of mRNA  1273 vaccine. The report mentioned the patient received medical treatment and intervention; however, no further information regarding the event was provided for medical reviewing. The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-623817 (Linked Report).; Sender's Comments: This life - threatening spontaneous case concerns a female patient of unknown age, with no medical history provided, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of COVID-19. Vaccination date from second dose was not reported; hence latency and temporal association cannot be properly assessed. The patient tested positive for COVID  19 approximately 9 months after the first dose of mRNA  1273 vaccine. The report mentioned the patient received medical treatment and intervention; however, no further information regarding the event was provided for medical reviewing. The benefit risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-623817:step dad case
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    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 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced VOMITING (Vomiting). In 2022, VOMITING (Vomiting) had resolved.            Concomitant medication was not reported.  In January 2022, the patient experienced vomiting. In 2022, the vomiting resolved. Moderna COVID-19 Vaccine (Elasomeran) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.   Treatment medication 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Flare up after COVID vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Flare up after COVID vaccination) 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) solution for injection for Plaque psoriasis and Rheumatoid arthritis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis) and Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONDITION AGGRAVATED (Flare up after COVID vaccination). At the time of the report, CONDITION AGGRAVATED (Flare up after COVID vaccination) had not resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was reported.  On an unknown date the blood work/immunity test result was not reported.  The reporters causality for the event flare up after COVID vaccination with Humira was no reasonable possibility.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Psoriasis
Clinical narrative: Plaque psoriasis flare up/break out on back; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis flare up/break out on back) and PAIN IN EXTREMITY (Pain in arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.  No Medical History information was reported.  On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis flare up/break out on back) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, PSORIASIS (Plaque psoriasis flare up/break out on back) had not resolved and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.    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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nauseated; Headache; This spontaneous case was reported by a consumer and describes the occurrence of (Nauseated) and (Headache) in an elderly female patient who received mRNA-1273  for COVID-19 prophylaxis.    Co-suspect product included non-company product (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form and (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled syringe. On an unknown date, the patient experienced(Nauseated) and (Headache). At the time of the report,  (Nauseated) and  (Headache) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medication was reported. On unknown dates, the patient experienced NAUSEATED and HEADACHE. On unknown dates, NAUSEATED and HEADACHE resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication 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.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient had Astra in May, BionTech in July and Moderna before Christmas.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had Astra in May, BionTech in July and Moderna before Christmas.) 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.     Previously administered products included for Product used for unknown indication: Astra in May 2021 and PFIZER BIONTECH COVID-19 VACCINE in July 2021. Past adverse reactions to the above products included No adverse event with Astra and PFIZER BIONTECH COVID-19 VACCINE.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had Astra in May, BionTech in July and Moderna before Christmas.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had Astra in May, BionTech in July and Moderna before Christmas.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Colitis ulcerative, Vaccination site pain
Clinical narrative: ULCERATIVE COLITIS FLARE UP; CONTRACTED COVID; VACCINE CAUSED SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) in an adult 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 Ulcerative colitis.    Concurrent medical conditions included Colitis ulcerative.   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 COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) (seriousness criterion medically significant), COVID-19 (CONTRACTED COVID) and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM). At the time of the report, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP), COVID-19 (CONTRACTED COVID) and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) had resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.   The reporter's causality for the event(s) of vaccine caused sore arm, contracted covid and ulcerative colitis flare up was not provided.  Company comment: This is a spontaneous case concerning an adult male patient with Ulcerative colitis on treatment with Adalimumab, who experienced the non-serious unexpected event COVID-19 (AESI) and colitis ulcerative flare up. The events occurred on an unknown date after the third dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult male patient with Ulcerative colitis on treatment with Adalimumab, who experienced the non-serious unexpected event COVID-19 (AESI) and colitis ulcerative flare up. The events occurred on an unknown date after the third dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 05-Mar-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) 75 milligram. In 2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). In 2021, DIZZINESS (Dizziness) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had fatigue and dizziness after taking the first dose.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain feels like freaking jellyfish; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brain feels like jellyfish) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain feels like jellyfish). At the time of the report, FEELING ABNORMAL (Brain feels like jellyfish) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Really sore arm; Based on the current case data, this case has been classified as invalid. This invalid case case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (Really sore arm) in subject of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Really sore arm). At the time of the report, VACCINATION SITE PAIN (Really sore arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: likely had a heart attack; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (likely had a heart attack) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) 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 (Spikevax) (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 CARDIAC DISORDER (likely had a heart attack). At the time of the report, CARDIAC DISORDER (likely had a heart attack) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported.  It was reported that the patient likely had a heart attack due to Moderna COVID-19 and Pfizer biotech COVID-19 vaccine.  No treatment 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.