chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site papule
Clinical narrative: RAISED RASH AT THE INJECTION SITE; Injection site papule; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (RAISED RASH AT THE INJECTION SITE) and VACCINATION SITE PAPULE (Injection site papule) in an elderly female patient who received mRNA-1273 (Spikevax) 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 dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced INJECTION SITE RASH (RAISED RASH AT THE INJECTION SITE) and VACCINATION SITE PAPULE (Injection site papule). At the time of the report, INJECTION SITE RASH (RAISED RASH AT THE INJECTION SITE) had not resolved and VACCINATION SITE PAPULE (Injection site papule) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of RAISED RASH AT THE INJECTION SITE unknown onset with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of RAISED RASH AT THE INJECTION SITE unknown onset was not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Inappropriate schedule of product administration, Malaise, SARS-CoV-2 test
Clinical narrative: Feeling unwell/ NOT FEELING WELL; 1st dose COVID-19 Vaccine 20-DEC-2020, 2nd dose COVID-19 Vaccine 1-Feb-2021; Illness; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), MALAISE (Feeling unwell/ NOT FEELING WELL), ILLNESS (Illness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose COVID-19 Vaccine 20-DEC-2020, 2nd dose COVID-19 Vaccine 1-Feb-2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 01-Jul-2021, the patient experienced COVID-19 (COVID-19). On 29-Dec-2021, the patient experienced ILLNESS (Illness). On an unknown date, the patient experienced MALAISE (Feeling unwell/ NOT FEELING WELL) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose COVID-19 Vaccine 20-DEC-2020, 2nd dose COVID-19 Vaccine 1-Feb-2021). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, MALAISE (Feeling unwell/ NOT FEELING WELL) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose COVID-19 Vaccine 20-DEC-2020, 2nd dose COVID-19 Vaccine 1-Feb-2021) outcome was unknown and ILLNESS (Illness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, SARS-CoV-2 test: (Positive) Positive.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient not feeling well after receiving Moderna COVID-19 booster; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient not feeling well after receiving Moderna COVID-19 booster) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    The patient's past medical history included Muscle pain in 2020.   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. In January 2022, the patient experienced IMMUNISATION REACTION (Patient not feeling well after receiving Moderna COVID-19 booster). At the time of the report, IMMUNISATION REACTION (Patient not feeling well after receiving Moderna COVID-19 booster) had not resolved.            No concomitant medication provided. No treatment information mentioned.  In Jan of 2021, patient was not feeling well after taking the Moderna COVID booster.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Joint swelling, Kidney infection, Lethargy
Clinical narrative: Asthenia; Lethargic; Kidney infection; Swollen ankles; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis aggravated.    Concurrent medical conditions included Diabetes, Gout and Rheumatoid arthritis (Moderate to Severe).   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 an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant). On an unknown date, the patient experienced JOINT SWELLING (Swollen ankles), ASTHENIA (Asthenia) and LETHARGY (Lethargic). At the time of the report, KIDNEY INFECTION (Kidney infection), ASTHENIA (Asthenia) and LETHARGY (Lethargic) outcome was unknown and JOINT SWELLING (Swollen ankles) had resolved.            The patient had swollen ankles which was lasted about two days. patient felt that it was due to cold weather. Stated that he felt rundown after getting the vaccine. patient was felt weaker, lethargic after getting the vaccine. Stated that he did not feel the same.  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  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 60-year-old male patient, with relevant medical condition of diabetes, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Upadacitinib for rheumatoid arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 60-year-old male patient, with relevant medical condition of diabetes, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Upadacitinib for rheumatoid arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: Two swollen lymphy nodes; Joints aching; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Two swollen lymphy nodes) and ARTHRALGIA (Joints aching) in a 67-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-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 ADALIMUMAB (HUMIRA) (Subcutaneous) .4 milliliter. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to .4 milliliter and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to .4 milliliter. On an unknown date, the patient experienced LYMPHADENOPATHY (Two swollen lymphy nodes) and ARTHRALGIA (Joints aching). At the time of the report, LYMPHADENOPATHY (Two swollen lymphy nodes) and ARTHRALGIA (Joints aching) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  On unknown dates patient reported two swollen lymph nodes and aching joints. Patient also reported negative reaction from last 3 Humira injections.  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: Migraine, Nasopharyngitis, Palpitations, Pyrexia, Tension headache
Clinical narrative: Migraines; Tight headiness; Racing heart; Cold; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), TENSION HEADACHE (Tight headiness), PALPITATIONS (Racing heart), NASOPHARYNGITIS (Cold) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-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 20-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 started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced MIGRAINE (Migraines), TENSION HEADACHE (Tight headiness), PALPITATIONS (Racing heart), NASOPHARYNGITIS (Cold) and PYREXIA (Fever). At the time of the report, MIGRAINE (Migraines) and NASOPHARYNGITIS (Cold) had not resolved and TENSION HEADACHE (Tight headiness), PALPITATIONS (Racing heart) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of MIGRAINES, TIGHT HEADINESS, RACING HEART, COLD and FEVER with RINVOQ(UPADACITINIB) 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Hypersensitivity, Insomnia
Clinical narrative: Rotator cuff issues; Skin on his arms and back bleeding; Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms; noticed more allergy symptoms; can't sleep; Had upset stomach/stomach is still woozy; Nausea; Shivering; Fever; aches and pain in his joints; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (Rotator cuff issues), SKIN HAEMORRHAGE (Skin on his arms and back bleeding), PRURITUS (Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms), INSOMNIA (can't sleep) and ABDOMINAL DISCOMFORT (Had upset stomach/stomach is still woozy) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis and Eczema.    The patient's past medical history included Fall in January 2022.   On 27-Jan-2022, the patient started DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. On 11-Apr-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced INSOMNIA (can't sleep), ABDOMINAL DISCOMFORT (Had upset stomach/stomach is still woozy), NAUSEA (Nausea), CHILLS (Shivering), PYREXIA (Fever) and ARTHRALGIA (aches and pain in his joints). On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff issues), SKIN HAEMORRHAGE (Skin on his arms and back bleeding), PRURITUS (Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms) and HYPERSENSITIVITY (noticed more allergy symptoms). The patient was treated with MELOXICAM for Rotator cuff syndrome, at an unspecified dose and frequency. At the time of the report, ROTATOR CUFF SYNDROME (Rotator cuff issues) had not resolved, SKIN HAEMORRHAGE (Skin on his arms and back bleeding), PRURITUS (Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms), INSOMNIA (can't sleep) and NAUSEA (Nausea) outcome was unknown, ABDOMINAL DISCOMFORT (Had upset stomach/stomach is still woozy) and CHILLS (Shivering) was resolving and PYREXIA (Fever), ARTHRALGIA (aches and pain in his joints) and HYPERSENSITIVITY (noticed more allergy symptoms) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Pyrexia, Rotator cuff syndrome, Skin haemorrhage
Clinical narrative: Rotator cuff issues; Skin on his arms and back bleeding; Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms; noticed more allergy symptoms; can't sleep; Had upset stomach/stomach is still woozy; Nausea; Shivering; Fever; aches and pain in his joints; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (Rotator cuff issues), SKIN HAEMORRHAGE (Skin on his arms and back bleeding), PRURITUS (Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms), INSOMNIA (can't sleep) and ABDOMINAL DISCOMFORT (Had upset stomach/stomach is still woozy) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis and Eczema.    The patient's past medical history included Fall in January 2022.   On 27-Jan-2022, the patient started DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. On 11-Apr-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced INSOMNIA (can't sleep), ABDOMINAL DISCOMFORT (Had upset stomach/stomach is still woozy), NAUSEA (Nausea), CHILLS (Shivering), PYREXIA (Fever) and ARTHRALGIA (aches and pain in his joints). On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff issues), SKIN HAEMORRHAGE (Skin on his arms and back bleeding), PRURITUS (Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms) and HYPERSENSITIVITY (noticed more allergy symptoms). The patient was treated with MELOXICAM for Rotator cuff syndrome, at an unspecified dose and frequency. At the time of the report, ROTATOR CUFF SYNDROME (Rotator cuff issues) had not resolved, SKIN HAEMORRHAGE (Skin on his arms and back bleeding), PRURITUS (Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms), INSOMNIA (can't sleep) and NAUSEA (Nausea) outcome was unknown, ABDOMINAL DISCOMFORT (Had upset stomach/stomach is still woozy) and CHILLS (Shivering) was resolving and PYREXIA (Fever), ARTHRALGIA (aches and pain in his joints) and HYPERSENSITIVITY (noticed more allergy symptoms) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant 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: Rash
Clinical narrative: Hand rash/hand rash after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Hand rash/hand rash after covid vaccine) in an elderly 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 known allergies were reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RASH (Hand rash/hand rash after covid vaccine). At the time of the report, RASH (Hand rash/hand rash after covid vaccine) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication details were provided. No treatment medication details were provided.   The reporter's causality for the event of rash with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Headache; Slight fever; Nausea; ARM PAIN FOLLOWED COVID BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (ARM PAIN FOLLOWED COVID BOOSTER), HEADACHE (Headache), PYREXIA (Slight fever) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Oct-2021, the patient experienced PAIN IN EXTREMITY (ARM PAIN FOLLOWED COVID BOOSTER). In January 2022, the patient experienced HEADACHE (Headache), PYREXIA (Slight fever) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (ARM PAIN FOLLOWED COVID BOOSTER) had not resolved and HEADACHE (Headache), PYREXIA (Slight fever) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. On 01-Oct-2021, the patient experienced severe arm pain followed covid booster. In January 2022, the patient experienced headache, slight fever, and nausea. 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: after first covid 19 vaccine arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (after first covid 19 vaccine arm was sore) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced VACCINATION SITE PAIN (after first covid 19 vaccine arm was sore). At the time of the report, VACCINATION SITE PAIN (after first covid 19 vaccine arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination site pain
Clinical narrative: Vaccination site pain; Suspected COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and SUSPECTED COVID-19 (Suspected COVID-19) 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.    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 14-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and SUSPECTED COVID-19 (Suspected COVID-19). The patient was treated with DENOSUMAB (PROLIA) at an unspecified dose and frequency and REPOSAL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not resolved and SUSPECTED COVID-19 (Suspected COVID-19) was resolving.            No concomitant medicine were provided. There was no reported medical history. For HUMIRA, the reporter causality for the event of Vaccination site pain was a reasonable possibility. and for the event of Suspected COVID-19 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.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Pyrexia
Clinical narrative: Flu-like symptoms; Fever chills; Drug dose administration interval too long; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), PARACETAMOL (TYLENOL 8 HOUR), APIXABAN (ELIQUIS), ALPRAZOLAM, EZETIMIBE, LISINOPRIL, ROSUVASTATIN and TACROLIMUS for an unknown indication.   On 06-Dec-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In January 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 31-Jan-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long). In 2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever chills) had resolved.            On unknown dates, the patient experienced flu-like symptoms and fever chills. In 2022, the patient experienced waited three weeks instead of two weeks to take humira due to received covid booster resolved. On unknown dates, flu-like symptoms and fever chills resolved.  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.
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Urinary tract disorder
Clinical narrative: DIABETIC; URINARY ISSUES; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (DIABETIC) 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 Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced DIABETES MELLITUS (DIABETIC) (seriousness criterion medically significant) and URINARY TRACT DISORDER (URINARY ISSUES). At the time of the report, DIABETES MELLITUS (DIABETIC) and URINARY TRACT DISORDER (URINARY ISSUES) was resolving.            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 urinary issues and diabetic with Humira (adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of Crohn's disease, who experienced the unexpected serious (medically significant) event of Diabetes mellitus after receiving a dose of mRNA-1273 vaccine. The onset date of the event was not reported. Patient received primary series of mRNA-1273 vaccine within the same month. Clinical course and treatment details were not reported. On unknown date, patient received Adalimumab for Crohn's disease which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of Crohn's disease, who experienced the unexpected serious (medically significant) event of Diabetes mellitus after receiving a dose of mRNA-1273 vaccine. The onset date of the event was not reported. Patient received primary series of mRNA-1273 vaccine within the same month. Clinical course and treatment details were not reported. On unknown date, patient received Adalimumab for Crohn's disease which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Vomiting, Weight, Weight decreased
Clinical narrative: Weight loss/ LOST TWENTY POUND; Fever/ HIGH FEVER; Swollen glands; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss/ LOST TWENTY POUND), PYREXIA (Fever/ HIGH FEVER), LYMPHADENOPATHY (Swollen glands) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced WEIGHT DECREASED (Weight loss/ LOST TWENTY POUND), PYREXIA (Fever/ HIGH FEVER), LYMPHADENOPATHY (Swollen glands) and VOMITING (Vomiting). At the time of the report, WEIGHT DECREASED (Weight loss/ LOST TWENTY POUND), PYREXIA (Fever/ HIGH FEVER), LYMPHADENOPATHY (Swollen glands) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: LOST TWENTY POUNDS.         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 medication was not provided.  No information regarding treatment medication was provided.  Humira was discontinued on an unknown date.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose 1 and 2 received on 01-JAN-2021 and 18-FEB-2021 More than 35 days apart; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 01-JAN-2021 and 18-FEB-2021 More than 35 days apart) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.  Concurrent medical conditions included Ankylosing spondylitis.  On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free (1 in 1 wk). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 01-JAN-2021 and 18-FEB-2021 More than 35 days apart) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 01-JAN-2021 and 18-FEB-2021 More than 35 days apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant products were not provided. Treatment medication were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in COVID-19 Vaccine trial.  The reporter's causality for the event (s) of WEAKNESS AND FATIGUE WITH FIRST COVID VACCINE onset in January 2021, WEAKNESS AND FATIGUE WITH FIRST COVID VACCINE onset in January 2021, STIFFNESS and PAIN was not provided.  This case was linked to MOD-2022-619944 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Her lips had abnormal swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (Her lips had abnormal swelling) 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 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced LIP SWELLING (Her lips had abnormal swelling). At the time of the report, LIP SWELLING (Her lips had abnormal swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The patient received Kysse product in lips on 05/Apr/2022. The next day 06/Apr/2022 she received the Moderna booster. Her lips had abnormal swelling. This was her 4th shot and she has not had filler injected in her lips in a few years.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration, Rash, Scar
Clinical narrative: Hair loss; Scar; Skin breakout; Drug dose administration interval too short; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss), SCAR (Scar), RASH (Skin breakout) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too short) 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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced ALOPECIA (Hair loss), SCAR (Scar), RASH (Skin breakout) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too short). At the time of the report, ALOPECIA (Hair loss), SCAR (Scar) and RASH (Skin breakout) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too short) outcome was unknown.            No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment details were reported. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of TOOK EXTRA INJECTION/TOOK INJECTION A WEEK EARLY with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of BREAKOUT ON HANDS, LOSING HAIR and SCAR ON FACE 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: Back disorder, Bursitis, Musculoskeletal discomfort
Clinical narrative: Bursitis and had been swollen; Hip problems; Back problems; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis and had been swollen), MUSCULOSKELETAL DISCOMFORT (Hip problems) and BACK DISORDER (Back problems) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BURSITIS (Bursitis and had been swollen), MUSCULOSKELETAL DISCOMFORT (Hip problems) and BACK DISORDER (Back problems). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BURSITIS (Bursitis and had been swollen), MUSCULOSKELETAL DISCOMFORT (Hip problems) and BACK DISORDER (Back problems) was resolving.            Concomitant product use was not provided by the reporter.  The patient had experienced bursitis and had been swollen. Patient had been off of Rinvoq for two weeks because patient took the Booster shot. Patient was back on Rinvoq as of 29-Dec-2021.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of bursitis, hip problems and back problems with Rinvoq was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received 1st dose COVID-19 vaccine moderna on 11 Mar 2021 and second dose on 09 Nov 2021; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose COVID-19 vaccine moderna on 11 Mar 2021 and second dose on 09 Nov 2021) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    There was no reported medical history.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose COVID-19 vaccine moderna on 11 Mar 2021 and second dose on 09 Nov 2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose COVID-19 vaccine moderna on 11 Mar 2021 and second dose on 09 Nov 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.   Formulation for HUMIRA was given as Solution for injection in pre-filled pen.  On an unknown date, the patient reported that HUMIRA was not working for her.  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.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: Weakness; bad muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (bad muscle aches) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), MYALGIA (bad muscle aches) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Weakness), MYALGIA (bad muscle aches) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported. Consumer did not wish to be contacted any further.  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-2022-620513 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: became real ill after the second shot; had a fever of 103; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (became real ill after the second shot) and PYREXIA (had a fever of 103) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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, the patient experienced ILLNESS (became real ill after the second shot) and PYREXIA (had a fever of 103). At the time of the report, ILLNESS (became real ill after the second shot) and PYREXIA (had a fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: had a fever of 103.         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-2022-620739 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: became real ill after the second shot; had a fever of 103; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (became real ill after the second shot) and PYREXIA (had a fever of 103) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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, the patient experienced ILLNESS (became real ill after the second shot) and PYREXIA (had a fever of 103). At the time of the report, ILLNESS (became real ill after the second shot) and PYREXIA (had a fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: had a fever of 103.         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-2022-620739 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: her first Moderna booster dose made her sick as well; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (her first Moderna booster dose made her sick as well) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced ILLNESS (her first Moderna booster dose made her sick as well). At the time of the report, ILLNESS (her first Moderna booster dose made her sick as well) 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.   This case was linked to MOD-2022-620735 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: her first Moderna booster dose made her sick as well; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (her first Moderna booster dose made her sick as well) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced ILLNESS (her first Moderna booster dose made her sick as well). At the time of the report, ILLNESS (her first Moderna booster dose made her sick as well) 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.   This case was linked to MOD-2022-620735 (Patient Link).