chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid; Covid; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of COVID-19 (Covid) and the second episode of COVID-19 (Covid) in a 42-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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced the first episode of COVID-19 (Covid). In October 2021, the patient experienced the second episode of COVID-19 (Covid). In 2021, last episode of COVID-19 (Covid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  Company comment: This is a spontaneous case concerning a 42-year-old female patient with Hidradenitis supurativa on treatment with Adalimumab, who experienced the non-serious unexpected event of COVID-19 (AESI), on the same month after the first dose of mRNA-1273 vaccine and a second episode of COVID-19 two months later. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 42-year-old female patient with Hidradenitis supurativa on treatment with Adalimumab, who experienced the non-serious unexpected event of COVID-19 (AESI), on the same month after the first dose of mRNA-1273 vaccine and a second episode of COVID-19 two months later. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) in a 63-year-old male 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In November 2021, the patient experienced BRONCHITIS (Bronchitis). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. In 2021, BRONCHITIS (Bronchitis) had resolved.            No concomitant medication was reported. The patient went to the emergency room and got a special cough syrup, cough pills, expectorant syrup, Amoxicillin, Prednisone. 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: VERY TIRED; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (VERY TIRED) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Mar-2021, the patient experienced FATIGUE (VERY TIRED). On 14-Mar-2021, FATIGUE (VERY TIRED) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   This case was linked to MOD-2021-624907 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Irritable bowel syndrome, Post-traumatic stress disorder
Clinical narrative: Irritable bowel syndrome symptoms; Symptoms of post-traumatic stress disorder; Fever; pain at injection site with pain and soreness; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome symptoms), POST-TRAUMATIC STRESS DISORDER (Symptoms of post-traumatic stress disorder), PYREXIA (Fever), VACCINATION SITE PAIN (pain at injection site with pain and soreness) and FATIGUE (Fatigue) 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) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 06-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome symptoms), POST-TRAUMATIC STRESS DISORDER (Symptoms of post-traumatic stress disorder), PYREXIA (Fever), VACCINATION SITE PAIN (pain at injection site with pain and soreness), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome symptoms) and POST-TRAUMATIC STRESS DISORDER (Symptoms of post-traumatic stress disorder) had not resolved and PYREXIA (Fever), VACCINATION SITE PAIN (pain at injection site with pain and soreness), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Body temperature: 101.1 for 48 hrs after covid booster.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment medication were provided.  The reporter's causality for the events of irritable bowel syndrome, fever, vaccination site pain, fatigue and headache with Humira(adalimumab) was no reasonable possibility and for post traumatic stress disorder causality 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Irritable bowel syndrome symptoms; Symptoms of post-traumatic stress disorder; Fever; pain at injection site with pain and soreness; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome symptoms), POST-TRAUMATIC STRESS DISORDER (Symptoms of post-traumatic stress disorder), PYREXIA (Fever), VACCINATION SITE PAIN (pain at injection site with pain and soreness) and FATIGUE (Fatigue) 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) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 06-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome symptoms), POST-TRAUMATIC STRESS DISORDER (Symptoms of post-traumatic stress disorder), PYREXIA (Fever), VACCINATION SITE PAIN (pain at injection site with pain and soreness), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome symptoms) and POST-TRAUMATIC STRESS DISORDER (Symptoms of post-traumatic stress disorder) had not resolved and PYREXIA (Fever), VACCINATION SITE PAIN (pain at injection site with pain and soreness), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Body temperature: 101.1 for 48 hrs after covid booster.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment medication were provided.  The reporter's causality for the events of irritable bowel syndrome, fever, vaccination site pain, fatigue and headache with Humira(adalimumab) was no reasonable possibility and for post traumatic stress disorder causality 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: Contusion
Clinical narrative: bruising in legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising in legs and feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruising in legs and feet). At the time of the report, CONTUSION (bruising in legs and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   One of the nieces had an adverse event and also had an acute case of ITP when she as a teenager struggling with Chronic Fatigue syndrome. 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.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: No improvement/gotten worst with humira; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (No improvement/gotten worst with humira) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (No improvement/gotten worst with humira). At the time of the report, CONDITION AGGRAVATED (No improvement/gotten worst with humira) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. On an unknown date, the patient experienced no improvement/gotten worst with Humira. No treatment medication reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Sinusitis
Clinical narrative: Sinus infection; Flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) in a 41-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 an unknown indication.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). On an unknown date, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) 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: Arthralgia, Fatigue, Feeling abnormal, Pain
Clinical narrative: AFTER COVID-19 BOOSTER NEXT MORNING FELT IF HAD BEEN IN A CAR ACCIDENT; PAINS WORSENING AFTER GETTING ON HUMIRA/ACHES/PAINS/VERY SORE AFTER TAKING COVID-19 BOOSTER; ON NECK DOWN JOINTS ACHE; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (AFTER COVID-19 BOOSTER NEXT MORNING FELT IF HAD BEEN IN A CAR ACCIDENT), PAIN (PAINS WORSENING AFTER GETTING ON HUMIRA/ACHES/PAINS/VERY SORE AFTER TAKING COVID-19 BOOSTER), ARTHRALGIA (ON NECK DOWN JOINTS ACHE) and FATIGUE (Fatigued) 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 Rheumatoid arthritis.    Previously administered products included for Drug use for unknown indication: ENBREL. Past adverse reactions to the above products included No adverse event with ENBREL. Concurrent medical conditions included Rheumatoid arthritis.   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. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced FEELING ABNORMAL (AFTER COVID-19 BOOSTER NEXT MORNING FELT IF HAD BEEN IN A CAR ACCIDENT), PAIN (PAINS WORSENING AFTER GETTING ON HUMIRA/ACHES/PAINS/VERY SORE AFTER TAKING COVID-19 BOOSTER), ARTHRALGIA (ON NECK DOWN JOINTS ACHE) and FATIGUE (Fatigued). At the time of the report, FEELING ABNORMAL (AFTER COVID-19 BOOSTER NEXT MORNING FELT IF HAD BEEN IN A CAR ACCIDENT) had resolved, PAIN (PAINS WORSENING AFTER GETTING ON HUMIRA/ACHES/PAINS/VERY SORE AFTER TAKING COVID-19 BOOSTER) and ARTHRALGIA (ON NECK DOWN JOINTS ACHE) had not resolved and FATIGUE (Fatigued) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment medication information was provided.  The reporter's causality with Humira (adalimumab): not provided for fatigued, on neck down joints ache and aches/pains/very sore after taking covid-19 booster, no reasonable possibility for event after covid-19 booster next morning felt if had been in a car accident and reasonable possibility for event pains worsening after getting on 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: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: LOOSE STOOL/WATERY STOOL; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (LOOSE STOOL/WATERY STOOL) in an elderly patient of an unknown gender 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 Ulcerative colitis.    The patient's past medical history included Loose stools.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-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 an unknown date, the patient experienced DIARRHOEA (LOOSE STOOL/WATERY STOOL). At the time of the report, DIARRHOEA (LOOSE STOOL/WATERY STOOL) 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: Injection site reaction, Joint swelling, Therapeutic product effect decreased
Clinical narrative: Drug effect decreased; Injection site reaction; Swollen joints; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased), INJECTION SITE REACTION (Injection site reaction) and JOINT SWELLING (Swollen joints) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased), INJECTION SITE REACTION (Injection site reaction) and JOINT SWELLING (Swollen joints). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased), INJECTION SITE REACTION (Injection site reaction) and JOINT SWELLING (Swollen joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication information was provided.  On unknown dates, patient experienced HUMIRA stopped working, reaction at injection site and joints to swell in back, neck and jaw with HUMIRA(ADALIMUMAB).   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  'This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Gastrooesophageal reflux disease, Vaccination site pain, Vaccination site pruritus
Clinical narrative: ACID REFLUX; ITCHINESS AFTER COVID-19 VACCINE AND FLU SHOT; SORE ARM AFTER COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (ACID REFLUX), VACCINATION SITE PRURITUS (ITCHINESS AFTER COVID-19 VACCINE AND FLU SHOT) and VACCINATION SITE PAIN (SORE ARM AFTER COVID-19 VACCINE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and INFLUENZA VACCINE for an unknown indication.    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., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (ACID REFLUX), VACCINATION SITE PRURITUS (ITCHINESS AFTER COVID-19 VACCINE AND FLU SHOT) and VACCINATION SITE PAIN (SORE ARM AFTER COVID-19 VACCINE). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (ACID REFLUX), VACCINATION SITE PRURITUS (ITCHINESS AFTER COVID-19 VACCINE AND FLU SHOT) and VACCINATION SITE PAIN (SORE ARM AFTER COVID-19 VACCINE) outcome was unknown.            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: U
Vaccine: COVID19
Symptoms: Anxiety, Energy increased, Fatigue, Feeling abnormal, Nausea
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (weird feeling), ANXIETY (less anxiety), ENERGY INCREASED (More energy), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epstein-Barr virus infection and Mononucleosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (weird feeling), ANXIETY (less anxiety), ENERGY INCREASED (More energy), NAUSEA (nausea), VACCINATION SITE PAIN (sore arm) and FATIGUE (Less fatigue). At the time of the report, FEELING ABNORMAL (weird feeling), ANXIETY (less anxiety), ENERGY INCREASED (More energy), NAUSEA (nausea), VACCINATION SITE PAIN (sore arm) and FATIGUE (Less fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported. Patient had IgG immunodeficiency. It was reported that patient received the first vaccine on 2nd April. Patient slept well the night after the vaccination and could do more of house-hold work which usually was not able to do after vaccination.  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: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (weird feeling), ANXIETY (less anxiety), ENERGY INCREASED (More energy), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epstein-Barr virus infection and Mononucleosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (weird feeling), ANXIETY (less anxiety), ENERGY INCREASED (More energy), NAUSEA (nausea), VACCINATION SITE PAIN (sore arm) and FATIGUE (Less fatigue). At the time of the report, FEELING ABNORMAL (weird feeling), ANXIETY (less anxiety), ENERGY INCREASED (More energy), NAUSEA (nausea), VACCINATION SITE PAIN (sore arm) and FATIGUE (Less fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported. Patient had IgG immunodeficiency. It was reported that patient received the first vaccine on 2nd April. Patient slept well the night after the vaccination and could do more of house-hold work which usually was not able to do after vaccination.  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: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Insomnia, Pain of skin, Rash
Clinical narrative: I am in pain because of the outbreak on my skin; I can't sleep; Severe allergic reaction to your 1st dose; I am in pain because of the outbreak on my skin; This spontaneous case was reported by a patient and describes the occurrence of PAIN OF SKIN (I am in pain because of the outbreak on my skin), INSOMNIA (I can't sleep), ALLERGY TO VACCINE (Severe allergic reaction to your 1st dose) and RASH (I am in pain because of the outbreak on my skin) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN OF SKIN (I am in pain because of the outbreak on my skin), INSOMNIA (I can't sleep), ALLERGY TO VACCINE (Severe allergic reaction to your 1st dose) and RASH (I am in pain because of the outbreak on my skin). At the time of the report, PAIN OF SKIN (I am in pain because of the outbreak on my skin), INSOMNIA (I can't sleep), ALLERGY TO VACCINE (Severe allergic reaction to your 1st dose) and RASH (I am in pain because of the outbreak on my skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. The patient had lost wages for a job that patient was on probation for a year. The patient had bloodwork twice by two different locations. Patient went to dermatologist. Patient was in pain because of the outbreak on skin and could not sleep. Patient was trying to overcome pain just to go to work. Treatment information was provided. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The patient had a sore arm after the first dose of the vaccine for about a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient had a sore arm after the first dose of the vaccine for about a day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient had a sore arm after the first dose of the vaccine for about a day). At the time of the report, VACCINATION SITE PAIN (The patient had a sore arm after the first dose of the vaccine for about a day) outcome was unknown. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a sore arm after the first dose of the vaccine for about a day. 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-2021-624903 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: My son (23 years) had 1 shot of Moderna's COVID vacccine and has myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID vacccine and has myocarditis) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID vacccine and has myocarditis) (seriousness criterion medically significant). The patient was treated with COLCHICINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID vacccine and has myocarditis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter stated that her son (23 years) had 1 shot of Moderna's COVID vaccine and had myocarditis and they won't let him get the 2nd shot. 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 reported by a consumer, concerns a 23 years old male patient with no relevant medical history reported, who experienced the expected, serious, medically significant AESI of MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID 19 Vaccine and has myocarditis) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that he was on colchicine. No further clinical information on comorbidities, risk factors, symptoms, labs, diagnostics and concomitant medications details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 23 years old male patient with no relevant medical history reported, who experienced the expected, serious, medically significant AESI of MYOCARDITIS (My son (23 years) had 1 shot of Moderna's COVID 19 Vaccine and has myocarditis) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that he was on colchicine. No further clinical information on comorbidities, risk factors, symptoms, labs, diagnostics and concomitant medications details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling hot, Peripheral swelling, Vaccination site reaction
Clinical narrative: swollen arm; Localised feeling of warmth; Vaccination site reaction; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE REACTION (Vaccination site reaction) and FEELING HOT (Localised feeling of warmth) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Bone spur in 1976, Knee swelling in 2011, Osteoarthritis in January 1996, Knee osteoarthritis in 2014, Osteoarthritis in 2011 and Foot surgery. Concurrent medical conditions included Osteoarthritis (in Nov-2020, knee Osteoarthritis in 2014, in 2011) since November 2020, Walking difficulty since 2011, Discomfort in joints (KNEE DISCOMFORT in 2011), Alcohol use (ALCOHOL USER/BEER AND GLASS OF WINE OCCATIONALLY) since 1976 and Non-tobacco user. Concomitant products included METHOTREXATE for Rheumatoid arthritis, FOLIC ACID for Supplementation therapy, DENOSUMAB (PROLIA) for an unknown indication.   In January 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). 11-Apr-2021, the patient experienced FEELING HOT (Localised feeling of warmth). In 2021, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction). On 25-Apr-2021, PERIPHERAL SWELLING (swollen arm) outcome was unknown, FEELING HOT (Localised feeling of warmth) had resolved. At the time of the report, VACCINATION SITE REACTION (Vaccination site reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: came positive for anti-bodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In 2021, the patient experienced bad reaction on left arm at covid vaccination site. On 11-Apr-2021 patient experienced feverish arm and arm got very swollen. On 01-Nov-2021, the patient underwent out patient total right knee replacement surgery with titanium joint. Patient chose not to have the second dose of covid 19 vaccine. 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: significant follow up- event added. On 18-Nov-2021: Significant follow up- event added On 20-Dec-2021: Live Significant Follow-up appended
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Presyncope
Clinical narrative: Vasovagal response; dangerous drop in blood pressure; This spontaneous case was reported by a patient and describes the occurrence of PRESYNCOPE (Vasovagal response) and BLOOD PRESSURE DECREASED (dangerous drop in blood pressure) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Vasovagal response) (seriousness criterion hospitalization) and BLOOD PRESSURE DECREASED (dangerous drop in blood pressure) (seriousness criterion hospitalization). At the time of the report, PRESYNCOPE (Vasovagal response) and BLOOD PRESSURE DECREASED (dangerous drop in blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: drop in blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. The patient recently received first dose of the covid-19 vaccine. During injection patient experienced and diagnosed with Vasovagal response and was hospitalized after a dangerous drop in blood pressure. Due to that experience patient had been advised by multiple medical professionals to abstain from receiving the subsequent dose of the product. No treatment information was provided.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who was hospitalized due to the unexpected, serious events of Presyncope and Blood pressure decreased, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who was hospitalized due to the unexpected, serious events of Presyncope and Blood pressure decreased, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Influenza like illness, Nasopharyngitis
Clinical narrative: shaking like cold extreme; stomach ache; drowsy; felt like flu; typical mild fever; body got into chills /shivering; legs hurt, hands hurts; has a mild headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (shaking like cold extreme), ABDOMINAL PAIN UPPER (stomach ache), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like flu) and PYREXIA (typical mild fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizure and Epilepsy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (shaking like cold extreme), ABDOMINAL PAIN UPPER (stomach ache), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like flu), PYREXIA (typical mild fever), CHILLS (body got into chills /shivering), PAIN IN EXTREMITY (legs hurt, hands hurts) and HEADACHE (has a mild headache). At the time of the report, NASOPHARYNGITIS (shaking like cold extreme), ABDOMINAL PAIN UPPER (stomach ache), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like flu), PYREXIA (typical mild fever), CHILLS (body got into chills /shivering) and PAIN IN EXTREMITY (legs hurt, hands hurts) outcome was unknown and HEADACHE (has a mild headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The reporter stated that twin sister and her twin sister's husband also experienced same events. Chest hurt for a little bit, for a full week.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: shaking like cold extreme; stomach ache; drowsy; felt like flu; typical mild fever; body got into chills /shivering; legs hurt, hands hurts; has a mild headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (shaking like cold extreme), ABDOMINAL PAIN UPPER (stomach ache), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like flu) and PYREXIA (typical mild fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizure and Epilepsy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (shaking like cold extreme), ABDOMINAL PAIN UPPER (stomach ache), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like flu), PYREXIA (typical mild fever), CHILLS (body got into chills /shivering), PAIN IN EXTREMITY (legs hurt, hands hurts) and HEADACHE (has a mild headache). At the time of the report, NASOPHARYNGITIS (shaking like cold extreme), ABDOMINAL PAIN UPPER (stomach ache), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like flu), PYREXIA (typical mild fever), CHILLS (body got into chills /shivering) and PAIN IN EXTREMITY (legs hurt, hands hurts) outcome was unknown and HEADACHE (has a mild headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The reporter stated that twin sister and her twin sister's husband also experienced same events. Chest hurt for a little bit, for a full week.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: the patient felt yucky the next day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (the patient felt yucky the next day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (the patient felt yucky the next day). At the time of the report, FEELING ABNORMAL (the patient felt yucky the next day) outcome was unknown. Not provided          After the second dose, the patient felt yucky the next day and then he was up like nothing had happened to him. The caller and the patient both have high blood pressure. 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-2021-624885 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Illness, Influenza, Pyrexia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Moderna vaccine kicked his butt and had him sick as), INFLUENZA (102 degree fever and felt l ke had a bad flu after Moderna Covid Vaccine) and PYREXIA (102 degree fever and felt  like I had a bad flu after Moderna Covid Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Patient took both doses of Pfizer.). Past adverse reactions to the above products included Pain in arm with Pfizer.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Moderna vaccine kicked his butt and had him sick as), INFLUENZA (102 degree fever and felt l ke had a bad flu after Moderna Covid Vaccine) and PYREXIA (102 degree fever and felt like I had a bad flu after Moderna Covid Vaccine). At the time of the report, ILLNESS (Moderna vaccine kicked his butt and had him sick as), INFLUENZA (102 degree fever and felt l ke had a bad flu after Moderna Covid Vaccine) and PYREXIA (102 degree fever and felt l ke had a bad flu after Moderna Covid Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: soreness; stiffness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and MUSCULOSKELETAL STIFFNESS (stiffness) in a 59-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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN (soreness) and MUSCULOSKELETAL STIFFNESS (stiffness). In 2021, PAIN (soreness) and MUSCULOSKELETAL STIFFNESS (stiffness) had resolved.            No concomitant medication information was provided. The patient had a double ear infection when she took the first Covid-19 vaccine when later presented hives.  She only had soreness and stiffness for one day after the second dose. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624340.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: LEFT SHOULDER PAIN; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (LEFT SHOULDER PAIN) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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) CF. On 09-Dec-2021, the patient experienced ARTHRALGIA (LEFT SHOULDER PAIN). In December 2021, ARTHRALGIA (LEFT SHOULDER PAIN) 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.   This case was linked to MOD-2021-624862 (Patient Link).