chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug interaction, Influenza like illness
Clinical narrative: Flu like symptom; Drug interaction; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptom), DRUG INTERACTION (Drug interaction) and COVID-19 (COVID-19) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) tablet for Lymphocytic leukemia and REMDESIVIR for COVID-19.    Concurrent medical conditions included Lymphocytic leukemia (Small lymphocytic leukemia).   In 2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day. In 2022, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 280 milligram once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and REMDESIVIR (unknown route) at an unspecified dose. In February 2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptom), DRUG INTERACTION (Drug interaction) and COVID-19 (COVID-19). In February 2022, INFLUENZA LIKE ILLNESS (Flu like symptom), DRUG INTERACTION (Drug interaction) and COVID-19 (COVID-19) had resolved.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Moderna vaccine caused achiness; Moderna vaccine caused fever; Moderna vaccine caused fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Moderna vaccine caused achiness), PYREXIA (Moderna vaccine caused fever) and FATIGUE (Moderna vaccine caused fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PAIN (Moderna vaccine caused achiness), PYREXIA (Moderna vaccine caused fever) and FATIGUE (Moderna vaccine caused fatigue). At the time of the report, PAIN (Moderna vaccine caused achiness), PYREXIA (Moderna vaccine caused fever) and FATIGUE (Moderna vaccine caused fatigue) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  Patient had Moderna vaccine and second dose caused fever, fatigue, and achiness.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of Moderna vaccine caused fever, Moderna vaccine caused fatigue, Moderna vaccine caused achiness with Skyrizi (risankizumab) 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.   This case was linked to MOD-2022-630370 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site haemorrhage, Vaccination site rash
Clinical narrative: bloody injection site; pulled  out needle/medication went everywhere; BLOODY INJECTION SITE/ SCRATCH; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bloody injection site), VACCINATION SITE RASH (BLOODY INJECTION SITE/ SCRATCH) and INCORRECT DOSE ADMINISTERED (pulled  out needle/medication went everywhere) 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) solution for injection 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) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2022, the patient experienced VACCINATION SITE RASH (BLOODY INJECTION SITE/ SCRATCH). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (bloody injection site) and INCORRECT DOSE ADMINISTERED (pulled  out needle/medication went everywhere). At the time of the report, VACCINATION SITE HAEMORRHAGE (bloody injection site) and VACCINATION SITE RASH (BLOODY INJECTION SITE/ SCRATCH) had resolved and INCORRECT DOSE ADMINISTERED (pulled  out needle/medication went everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of humira as per reporter for events vaccination site bleeding, vaccination site rash and Inappropriate dose of drug administered was no reasonable possibility. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free pre-filled pen. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (cancer) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Chemotherapy NOS (The patient was currently on chemo treatments) since an unknown date.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced NEOPLASM MALIGNANT (cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (cancer) outcome was unknown.            No concomitant medication were reported.  Patient had clean mammogram prior to vaccine.  The reporters causality for the event of CANCER was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns an elderly female patient, in treatment with co  suspect product Adalimumab for Rheumatoid arthritis, who received two doses of mRNA-1273 vaccine and experienced the serious medically significant unexpected event of neoplasm malignant. Onset date of the event was not provided, hence latency and temporal association cannot be properly assessed. No further information has been provided for medical reviewing. The report mentioned the patient was currently on chemo treatments, which could be a confounding factor. 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, in treatment with co  suspect product Adalimumab for Rheumatoid arthritis, who received two doses of mRNA-1273 vaccine and experienced the serious medically significant unexpected event of neoplasm malignant. Onset date of the event was not provided, hence latency and temporal association cannot be properly assessed. No further information has been provided for medical reviewing. The report mentioned the patient was currently on chemo treatments, which could be a confounding factor. The benefit  risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: patient has mixed adrenal insufficiency (prior tovaccines) and suffered from convulsions, neuropathy, migraines and more for most of her life. each dose gave her a rush of energy not felt since childhood within about 15 minutes, and in the days.; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (patient has mixed adrenal insufficiency (prior tovaccines) and suffered from convulsions, neuropathy, migraines and more for most of her life. each dose gave her a rush of energy not felt since childhood within about 15 minutes, and in the days.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adrenal insufficiency since an unknown date. Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1 Batch/Lot No: er8734) on 06-Apr-2021, Pfizer (Dose Number: 2 Batch/Lot No: er7533) on 27-Apr-2021 and Pfizer (Dose Number: 3 Batch/Lot No: fe3590) on 02-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Penicillin allergy, Convulsions, Neuropathy, Migraine, Chronic back pain and Food allergy. Concomitant products included TOPIRAMATE (TOPAMAX), CANNABINOIDS NOS and N-ACETYLCYSTEINE for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (patient has mixed adrenal insufficiency (prior tovaccines) and suffered from convulsions, neuropathy, migraines and more for most of her life. each dose gave her a rush of energy not felt since childhood within about 15 minutes, and in the days.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (patient has mixed adrenal insufficiency (prior tovaccines) and suffered from convulsions, neuropathy, migraines and more for most of her life. each dose gave her a rush of energy not felt since childhood within about 15 minutes, and in the days.) 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.  The concomitant medication was reported as Angestrin.   Patient reported that she had mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life and each dose gave her a rush of energy not felt since childhood' within about 15 minutes post vaccination, and her chronic back pain went away, food irritations, and other complications eased.  The treatment medication was not reported.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: Last two times got COVID were definitely less severe than the first three times; Patient got Pfizer, Moderna and JnJ; Patient got Pfizer, Moderna and JnJ; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Last two times got COVID were definitely less severe than the first three times), INTERCHANGE OF VACCINE PRODUCTS (Patient got Pfizer, Moderna and JnJ) and COVID-19 IMMUNISATION (Patient got Pfizer, Moderna and JnJ) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN 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, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Last two times got COVID were definitely less severe than the first three times), INTERCHANGE OF VACCINE PRODUCTS (Patient got Pfizer, Moderna and JnJ) and COVID-19 IMMUNISATION (Patient got Pfizer, Moderna and JnJ). At the time of the report, COVID-19 (Last two times got COVID were definitely less severe than the first three times), INTERCHANGE OF VACCINE PRODUCTS (Patient got Pfizer, Moderna and JnJ) and COVID-19 IMMUNISATION (Patient got Pfizer, Moderna and JnJ) outcome was unknown.            No concomitant product was reported. 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.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Congestion; slight headache; Patient is in Treatment for COVID-19 with Paxlovid/rebound COVID-19 symptoms/Tested positive again; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient is in Treatment for COVID-19 with Paxlovid/rebound COVID-19 symptoms/Tested positive again), NASAL CONGESTION (Congestion) and HEADACHE (slight headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No other medical history reported.  Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2022, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. In April 2022, the patient experienced COVID-19 (Patient is in Treatment for COVID-19 with Paxlovid/rebound COVID-19 symptoms/Tested positive again). On 05-May-2022, the patient experienced NASAL CONGESTION (Congestion) and HEADACHE (slight headache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-Apr-2022 to 29-Apr-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient is in Treatment for COVID-19 with Paxlovid/rebound COVID-19 symptoms/Tested positive again) had not resolved and NASAL CONGESTION (Congestion) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2022, SARS-CoV-2 test: (Negative) negative. On 06-May-2022, SARS-CoV-2 test: (Positive) Positive.         Patient Date of birth was reported.  It was reported that On 05-May-2022, the patient developed rebound COVID-19 symptoms. Congestion and slight headache. Patient had tested negative via BinaxNOW antigen home test after Paxlovid dosing finished and again tested positive with BinaxNOW antigen home test.  This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS CAME BACK WITH A VENGEANCE; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS CAME BACK WITH A VENGEANCE) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS CAME BACK WITH A VENGEANCE) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS CAME BACK WITH A VENGEANCE) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of Rheumatoid arthritis flare up was not provided.  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.  Company comment: This spontaneous case concerns an adult female patient of unknown age with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint swelling, Pyrexia
Clinical narrative: Right hand, joints and knuckles get swollen; Right hand, joints and knuckles hurt; Vaccine caused headache for two days; Vaccine caused fever for two days; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right hand, joints and knuckles get swollen), ARTHRALGIA (Right hand, joints and knuckles hurt), HEADACHE (Vaccine caused headache for two days) and PYREXIA (Vaccine caused fever for two days) in a 38-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-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 ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Right hand, joints and knuckles get swollen), ARTHRALGIA (Right hand, joints and knuckles hurt), HEADACHE (Vaccine caused headache for two days) and PYREXIA (Vaccine caused fever for two days). At the time of the report, JOINT SWELLING (Right hand, joints and knuckles get swollen) and ARTHRALGIA (Right hand, joints and knuckles hurt) was resolving and HEADACHE (Vaccine caused headache for two days) and PYREXIA (Vaccine caused fever for two days) had resolved.            No concomitant medication was reported. No treatment medication was reported.  The reporter's causality for the events of right hand, joints and knuckles get swollen, right hand, joints and knuckles hurt, vaccine caused headache for two days and vaccine caused fever for two days was not provided for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Reaction to psoriasis, hands started to get bad, hand got scaly, crackly/got little spots on sides belt or waist sides/ Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Reaction to psoriasis, hands started to get bad, hand got scaly, crackly/got little spots on sides belt or waist sides/ Psoriasis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Reaction to psoriasis, hands started to get bad, hand got scaly, crackly/got little spots on sides belt or waist sides/ Psoriasis). At the time of the report, PSORIASIS (Reaction to psoriasis, hands started to get bad, hand got scaly, crackly/got little spots on sides belt or waist sides/ Psoriasis) had resolved.            Relevant concomitant medications were not reported.  The patient's booster dose triggered a reaction to psoriasis, per his doctor his hands started to get bad, hand got scaly and crackly and he got little spots on his sides belt or waist sides. The symptoms of hand scaly and crackly was unifying under diagnosis psoriasis. The doctor prescribed an unknown cream for this.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality for the event of triggered a reaction to psoriasis, hands started to get bad, hand got scaly and crackly and got little spots on sides belt or waist sides with SKYRIZI 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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: Not feeling good; Started having rashes on her hips on both sides/ the rash start to go to her abdomen, butt cheeks, and back; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good) and RASH (Started having rashes on her hips on both sides/ the rash start to go to her abdomen, butt cheeks, and back) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   No Medical History information was reported.  In February 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced FEELING ABNORMAL (Not feeling good) and RASH (Started having rashes on her hips on both sides/ the rash start to go to her abdomen, butt cheeks, and back). At the time of the report, FEELING ABNORMAL (Not feeling good) and RASH (Started having rashes on her hips on both sides/ the rash start to go to her abdomen, butt cheeks, and back) 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. Patient's rashes are similar to mosquito bites and there are no big lesions. Patient takes  medications but reporter does not have a list. 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: Blood glucose, Blood pressure measurement, Blood triglycerides, Diarrhoea, Emotional distress
Clinical narrative: More pain; Blood pressure was so high because patient was upset; Blood pressure was so high because patient was upset; Diarrhea; Nauseated; Bump on the reaction site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (More pain), HYPERTENSION (Blood pressure was so high because patient was upset), EMOTIONAL DISTRESS (Blood pressure was so high because patient was upset), DIARRHOEA (Diarrhea) and NAUSEA (Nauseated) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (More pain), HYPERTENSION (Blood pressure was so high because patient was upset), EMOTIONAL DISTRESS (Blood pressure was so high because patient was upset), DIARRHOEA (Diarrhea), NAUSEA (Nauseated) and INJECTION SITE PAPULE (Bump on the reaction site). At the time of the report, PAIN (More pain), HYPERTENSION (Blood pressure was so high because patient was upset) and EMOTIONAL DISTRESS (Blood pressure was so high because patient was upset) outcome was unknown and DIARRHOEA (Diarrhea), NAUSEA (Nauseated) and INJECTION SITE PAPULE (Bump on the reaction site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: High. On an unknown date, Blood pressure measurement: High. On an unknown date, Blood triglycerides: High.         No concomitant medication was reported. No treatment medication was reported.  Latest Moderna vaccine was booster vaccine.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of more pain, nauseated, diarrhea, bump on the reaction site, blood pressure was so high because patient was upset, high sugar and high triglycerides was not provided for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Injection site papule, Nausea, Pain
Clinical narrative: More pain; Blood pressure was so high because patient was upset; Blood pressure was so high because patient was upset; Diarrhea; Nauseated; Bump on the reaction site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (More pain), HYPERTENSION (Blood pressure was so high because patient was upset), EMOTIONAL DISTRESS (Blood pressure was so high because patient was upset), DIARRHOEA (Diarrhea) and NAUSEA (Nauseated) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (More pain), HYPERTENSION (Blood pressure was so high because patient was upset), EMOTIONAL DISTRESS (Blood pressure was so high because patient was upset), DIARRHOEA (Diarrhea), NAUSEA (Nauseated) and INJECTION SITE PAPULE (Bump on the reaction site). At the time of the report, PAIN (More pain), HYPERTENSION (Blood pressure was so high because patient was upset) and EMOTIONAL DISTRESS (Blood pressure was so high because patient was upset) outcome was unknown and DIARRHOEA (Diarrhea), NAUSEA (Nauseated) and INJECTION SITE PAPULE (Bump on the reaction site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: High. On an unknown date, Blood pressure measurement: High. On an unknown date, Blood triglycerides: High.         No concomitant medication was reported. No treatment medication was reported.  Latest Moderna vaccine was booster vaccine.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of more pain, nauseated, diarrhea, bump on the reaction site, blood pressure was so high because patient was upset, high sugar and high triglycerides was not provided for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  Reportedly, patient had received all three doses including the booster were from Moderna and later the patient died.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving the third (booster) 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 patient 'had been treated with a mRNA vaccine and that later the mother died'. The reporter confirmed that the patient received all three doses of the mRNA-1273 vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving the third (booster) 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 patient 'had been treated with a mRNA vaccine and that later the mother died'. The reporter confirmed that the patient received all three doses of the mRNA-1273 vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 69-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 Plaque psoriasis.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-619780.   Reporter did not allow further contact
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Headache, Malaise, Nausea
Clinical narrative: Feeling bad; Flushing; Headache; Nausea; Ill feeling; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill feeling), FEELING ABNORMAL (Feeling bad), FLUSHING (Flushing), HEADACHE (Headache) and NAUSEA (Nausea) 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 an unknown indication.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-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 05-Mar-2022, the patient experienced MALAISE (Ill feeling). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad), FLUSHING (Flushing), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, MALAISE (Ill feeling) had not resolved and FEELING ABNORMAL (Feeling bad), FLUSHING (Flushing), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            There was no reported medical history.   Concomitant drugs not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the events of feeling ill and lack of effect was a reasonable possibility and for events feeling like crap, headache, nausea and feeling flush was not provided with humira (adalimumab).  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Hyperhidrosis, SARS-CoV-2 test
Clinical narrative: SWEATING; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (SWEATING) and COVID-19 (COVID-19) in a 69-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 Plaque psoriasis.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-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. On 03-Feb-2022, the patient experienced HYPERHIDROSIS (SWEATING). In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, HYPERHIDROSIS (SWEATING) and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.         No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-619763.
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-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) (unknown route) at an unspecified dose. On 01-Mar-2022, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) was resolving.            No concomitant and treatment medication were provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. There is no reasonable possibility of event tiredness with HUMIRA. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Depressed mood, Hangover, Somnolence
Clinical narrative: Sleepy; COVID-19 BOOSTER DOSE KNOCKED DOWN; FELT LIKE HAD HANGOVER; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), DEPRESSED MOOD (COVID-19 BOOSTER DOSE KNOCKED DOWN) and HANGOVER (FELT LIKE HAD HANGOVER) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    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, RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) at an unspecified dose and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), DEPRESSED MOOD (COVID-19 BOOSTER DOSE KNOCKED DOWN) and HANGOVER (FELT LIKE HAD HANGOVER). At the time of the report, SOMNOLENCE (Sleepy) had resolved, DEPRESSED MOOD (COVID-19 BOOSTER DOSE KNOCKED DOWN) was resolving and HANGOVER (FELT LIKE HAD HANGOVER) outcome was unknown.            No concomitant medications were reported. Patient stated after he took second COVID vaccine he was sleepy the next day, but when he did the booster dose, it knocked him down and he felt like he had a hangover all of the next day. After the third shot of the Skyrizi, he cleared up significantly and since it has been a year, it was almost like he did not had psoriasis anymore. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; Plaque psoriasis/groin area resistant; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in an adult male 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) solution for solution for injection for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant) and PSORIASIS (Plaque psoriasis/groin area resistant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) and PSORIASIS (Plaque psoriasis/groin area resistant) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medication were provided It was unknown if the patient was enrolled in COVID-19 trial. Reporter causality for event Psoriatic arthritis was not reported with Humira. There was no reasonable possibility for event Psoriasis with Humira. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an adult male patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, 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. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult male patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, 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. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Psoriasis, Pyrexia
Clinical narrative: Psoriasis of scalp; Patient had dose 1 on 20 Aug 2021 and dose 2 on 05 Jan 2022; Horrible high fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 20 Aug 2021 and dose 2 on 05 Jan 2022), PSORIASIS (Psoriasis of scalp) and PYREXIA (Horrible high fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1st dose (1 in 1). On 05-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 20 Aug 2021 and dose 2 on 05 Jan 2022). In January 2022, the patient experienced PYREXIA (Horrible high fever). On an unknown date, the patient experienced PSORIASIS (Psoriasis of scalp). In January 2022, PYREXIA (Horrible high fever) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 20 Aug 2021 and dose 2 on 05 Jan 2022) outcome was unknown and PSORIASIS (Psoriasis of scalp) was resolving.            Patient had Skyrizi which had cleared all but not her scalp. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, the patient experienced SKYRIZI not clear plaque psoriasis on scalp. 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.