chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Colonoscopy, Diarrhoea, Large intestine polyp, Pyrexia
Clinical narrative: Colonoscopy showed precancerous polyp; Uncontrollable diarrhea; Rheumatoid arthritis pain; Fever after moderna covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINE POLYP (Colonoscopy showed precancerous polyp), DIARRHOEA (Uncontrollable diarrhea), ARTHRALGIA (Rheumatoid arthritis pain) and PYREXIA (Fever after moderna covid vaccine) in a 61-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 and Ulcerative colitis.    The patient's past medical history included COVID-19 in 2020. Concomitant products included COLESTIPOL HCL and CELECOXIB (CELEBREX) for an unknown indication.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced LARGE INTESTINE POLYP (Colonoscopy showed precancerous polyp), DIARRHOEA (Uncontrollable diarrhea), ARTHRALGIA (Rheumatoid arthritis pain) and PYREXIA (Fever after moderna covid vaccine). In 2021, LARGE INTESTINE POLYP (Colonoscopy showed precancerous polyp) and PYREXIA (Fever after moderna covid vaccine) had resolved. At the time of the report, DIARRHOEA (Uncontrollable diarrhea) was resolving and ARTHRALGIA (Rheumatoid arthritis pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, Colonoscopy: Showed precancerous polyp.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drug information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of COLONOSCOPY SHOWED PRECANCEROUS POLYP, RHEUMATOID ARTHRITIS PAIN, UNCONTROLLABLE DIARRHEA and FEVER AFTER MODERNA COVID VACCINE with HUMIRA 40MG/0.4ML(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.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-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) CF. In April 2021, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) had not resolved.            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.   This case was linked to MOD-2021-623564 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Previously administered products included for Product used for unknown indication: CODEINE. Past adverse reactions to the above products included No adverse event with CODEINE. Concurrent medical conditions included Psoriasis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had soreness in arm around injection area due to covid-19 vaccine.  The reporter's causality for the event of Vaccination site pain was reported as no reasonable possibility for Skyrizi.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Joint swelling, Tendon rupture
Clinical narrative: SWELLING IN LEFT SHOULDER; INCREASED PAIN IN LEFT SHOULDER; TWO TENDONS RUPTURED ON LEFT HAND; This spontaneous case was reported by a consumer and describes the occurrence of TENDON RUPTURE (TWO TENDONS RUPTURED ON LEFT HAND), JOINT SWELLING (SWELLING IN LEFT SHOULDER) and ARTHRALGIA (INCREASED PAIN IN LEFT SHOULDER) in a 40-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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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) Citrate free. In April 2022, the patient experienced TENDON RUPTURE (TWO TENDONS RUPTURED ON LEFT HAND). On an unknown date, the patient experienced JOINT SWELLING (SWELLING IN LEFT SHOULDER) and ARTHRALGIA (INCREASED PAIN IN LEFT SHOULDER). At the time of the report, TENDON RUPTURE (TWO TENDONS RUPTURED ON LEFT HAND) was resolving and JOINT SWELLING (SWELLING IN LEFT SHOULDER) and ARTHRALGIA (INCREASED PAIN IN LEFT SHOULDER) outcome was unknown.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of Tendon rupture, Joint swelling, Arthralgia aggravated was assessed as "Not reported" for cosuspect humira. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Discomfort, Mucous stools, Weight, Weight decreased
Clinical narrative: Mucus stools; Discomfort; Particularly urgency going and often diarrhea/Bowels move almost immediately after ate; Weight Loss; This spontaneous case was reported by a consumer and describes the occurrence of MUCOUS STOOLS (Mucus stools), DISCOMFORT (Discomfort), WEIGHT DECREASED (Weight Loss) and DIARRHOEA (Particularly urgency going and often diarrhea/Bowels move almost immediately after ate) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Blood pressure high and Weight loss.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced WEIGHT DECREASED (Weight Loss). On 06-Jul-2021, the patient experienced MUCOUS STOOLS (Mucus stools), DISCOMFORT (Discomfort) and DIARRHOEA (Particularly urgency going and often diarrhea/Bowels move almost immediately after ate). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, MUCOUS STOOLS (Mucus stools), WEIGHT DECREASED (Weight Loss) and DIARRHOEA (Particularly urgency going and often diarrhea/Bowels move almost immediately after ate) had not resolved and DISCOMFORT (Discomfort) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: Weight loss.   No concomitant medication details were provided.  The reporter's causality for the events with HUMIRA 40MG/0.4ML(ADALIMUMAB) was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623426 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Light headedness; Fever; Headache; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Weight loss in 2020. Concurrent medical conditions included Blood pressure high since 2015.   In July 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced DIZZINESS (Light headedness), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, DIZZINESS (Light headedness), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) 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 Light headedness, Fever, Headaches, Muscle pain and Joint pain with Humira was not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623419 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: FELT ACHY DUE TO BOOSTER; TIRED DUE TO BOOSTER COVID VACCINE; FEVER DUE TO BOOSTER COVID VACCINE; This spontaneous case was reported by a patient and describes the occurrence of PAIN (FELT ACHY DUE TO BOOSTER), FATIGUE (TIRED DUE TO BOOSTER COVID VACCINE) and PYREXIA (FEVER DUE TO BOOSTER COVID VACCINE) 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) solution for injection for Crohn's disease.    The patient's past medical history included Bronchitis and Hysterectomy in March 2021. Concurrent medical conditions included Crohn's disease.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 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) Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen. In August 2021, the patient experienced PAIN (FELT ACHY DUE TO BOOSTER), FATIGUE (TIRED DUE TO BOOSTER COVID VACCINE) and PYREXIA (FEVER DUE TO BOOSTER COVID VACCINE). At the time of the report, PAIN (FELT ACHY DUE TO BOOSTER), FATIGUE (TIRED DUE TO BOOSTER COVID VACCINE) and PYREXIA (FEVER DUE TO BOOSTER COVID VACCINE) had resolved.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of  TIRED DUE TO BOOSTER COVID VACCINE, FEVER DUE TO BOOSTER COVID VACCINE and FELT ACHY DUE TO BOOSTER COVID VACCINE with HUMIRA was no reasonable possibility.  Treatment details were not given.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to US-MODERNATX, INC.-MOD-2021-621585 (E2B Linked Report). This case was linked to MOD-2021-621585 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-621585:Dose 1
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Magnetic resonance imaging, Vaccination site pain, X-ray limb
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Tobacco user (Four Cigarette Sticks A Day) from 1986 to 2014 and Alcohol use (Beer, Hard Liquor, Variety, Occasionally) from 1990 to 1999. Concurrent medical conditions included Bowel adhesions (Lot Of Scar Tissue In Colon), Bowel obstruction (bowel blockages), Bowel discomfort (Trouble With Bowel Movements), Acid reflux (esophageal) and Crohn's disease. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal).   In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 26-Jun-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Magnetic resonance imaging: Showed torn left rotator cuff and left tendon bicep. In 2020, X-ray limb: Showed torn left rotator cuff and left tendon bicep.         The patient had no known allergies.   The reporter's causality for the event vaccination site pain was reported as not related to Humira.  Primary reporter does not had the lot number information, because the information was not available in the patient's file for Humira.  The patient experienced recurrent sore right shoulder due to Covid vaccine. A day after the patient got vaccinated for Covid-19 on each dose patient experienced a sore right shoulder that lasted for two to three days but that was the only side effect  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624662 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rhinorrhoea, Sneezing, Vaccination site erythema, Vaccination site pain
Clinical narrative: Runny nose; Sneezing; Injection site burning; Vaccination site burning; Injection site papule; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), SNEEZING (Sneezing), INJECTION SITE PAIN (Injection site burning), VACCINATION SITE PAIN (Vaccination site burning) and VACCINATION SITE PAPULE (Injection site papule) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriasis vulgaris.    No Medical History information was reported.   On 14-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 160 milligram. In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In July 2021, the patient experienced RHINORRHOEA (Runny nose), SNEEZING (Sneezing), INJECTION SITE PAIN (Injection site burning), VACCINATION SITE PAIN (Vaccination site burning), VACCINATION SITE PAPULE (Injection site papule) and VACCINATION SITE ERYTHEMA (Injection site redness). The last dose administered for ADALIMUMAB (HUMIRA) was on 22-Jul-2021. In July 2021, INJECTION SITE PAIN (Injection site burning) and VACCINATION SITE PAPULE (Injection site papule) had resolved, VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown. At the time of the report, RHINORRHOEA (Runny nose), SNEEZING (Sneezing) and VACCINATION SITE PAIN (Vaccination site burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No known drug allergy. No concomitant drugs taken. The reporter's causality for the event(s) of burning with moderna vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of injection site burning, injection site red/raised with HUMIRA(ADALIMUMAB) was a reasonable possibility. Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site papule
Clinical narrative: Runny nose; Sneezing; Injection site burning; Vaccination site burning; Injection site papule; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), SNEEZING (Sneezing), INJECTION SITE PAIN (Injection site burning), VACCINATION SITE PAIN (Vaccination site burning) and VACCINATION SITE PAPULE (Injection site papule) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriasis vulgaris.    No Medical History information was reported.   On 14-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 160 milligram. In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In July 2021, the patient experienced RHINORRHOEA (Runny nose), SNEEZING (Sneezing), INJECTION SITE PAIN (Injection site burning), VACCINATION SITE PAIN (Vaccination site burning), VACCINATION SITE PAPULE (Injection site papule) and VACCINATION SITE ERYTHEMA (Injection site redness). The last dose administered for ADALIMUMAB (HUMIRA) was on 22-Jul-2021. In July 2021, INJECTION SITE PAIN (Injection site burning) and VACCINATION SITE PAPULE (Injection site papule) had resolved, VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown. At the time of the report, RHINORRHOEA (Runny nose), SNEEZING (Sneezing) and VACCINATION SITE PAIN (Vaccination site burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No known drug allergy. No concomitant drugs taken. The reporter's causality for the event(s) of burning with moderna vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of injection site burning, injection site red/raised with HUMIRA(ADALIMUMAB) was a reasonable possibility. Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cardiac failure, Feeling abnormal
Clinical narrative: Heart failure; felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Heart failure) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) tablet for an unknown indication.    Concomitant products included LINACLOTIDE (LINZESS) for an unknown indication.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) 100 microgram. In July 2021, the patient experienced CARDIAC FAILURE (Heart failure) (seriousness criterion medically significant) and FEELING ABNORMAL (felt terrible). At the time of the report, CARDIAC FAILURE (Heart failure) outcome was unknown and FEELING ABNORMAL (felt terrible) had not resolved.            The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The alternative etiology of event heart failure and felt terrible was Covid 19 Vaccine. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment. This spontaneous case concerns a 71  year  old, female patient, in treatment with levothyroxine sodium, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious (medically significant) unexpected  of cardiac failure. Exact vaccination date and onset date of the event was not reported; hence latency and temporal association cannot be properly assessed. The outcome was not recovered. No further clinical information was available for medical reviewing. Co  suspect product included patient´s concomitant levothyroxine sodium which could be cofounder for heart failure. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71  year  old, female patient, in treatment with levothyroxine sodium, who received two doses of mRNA-1273 vaccine (unknown schedule) and experienced the serious (medically significant) unexpected of cardiac failure. Exact vaccination date and onset date of the event was not reported; hence latency and temporal association cannot be properly assessed. The outcome was not recovered. No further clinical information was available for medical reviewing. suspect product included patient´s concomitant levothyroxine sodium which could be cofounder for heart failure. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Hidradenitis
Clinical narrative: Hidradenitis suppurativa; Pain in joint involving hand; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa) and ARTHRALGIA (Pain in joint involving hand) in a 63-year-old 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) for Hidradenitis suppurativa.    No Medical History information was reported.   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In September 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa) and ARTHRALGIA (Pain in joint involving hand). In 2021, ARTHRALGIA (Pain in joint involving hand) had resolved. At the time of the report, HIDRADENITIS (Hidradenitis suppurativa) outcome was unknown.            Concomitant Drugs Not Reported  The reporter's causality for the event(s) of pain in elbow to wrist after covid injection with Humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of hidradenitis suppurativa flare was not provided.  Treatment Drugs 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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hepatic enzyme, Pain, Pyrexia, Tremor
Clinical narrative: shaking; Major bodyache; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking), PAIN (Major bodyache), PYREXIA (fever) and CHILLS (chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Asthma and Nasal polyps.    Concurrent medical conditions included Essential hypertension, Gastroesophageal reflux disease, Hyperlipidemia, Drug allergy (with Ceftin), Drug allergy (Niaspan extended-Release), Drug allergy (Zocor), Drug allergy (Lamisil), Asthma and Nasal polyps. Concomitant products included OMEPRAZOLE, AZELASTINE;FLUTICASONE, SALBUTAMOL SULFATE (VENTOLIN HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB), MONTELUKAST SODIUM, ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE;BENAZEPRIL, DIAZEPAM, SALBUTAMOL (ALBUTEROL HFA) and HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HYDROCHLOROTHIAZIDE) for an unknown indication.   On 01-Aug-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 mg every other week (strength: 150mg/ml). On 18-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced TREMOR (shaking), PAIN (Major bodyache), PYREXIA (fever) and CHILLS (chills). At the time of the report, TREMOR (shaking), PAIN (Major bodyache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Hepatic enzyme: Elevated.         Patient had little bubble form under skin after dupilumab injection and noted some mild pain near injection site . Spoke with pharmacist who advised that it was not recommended to be on an ace and an arb at the same time due to risk of renal issues and hyperkalemia. He stated he'd talk to his physician about that. He also discussed he had some soreness in his leg still. It was not bad and it's not red or otherwise discolored but wanted to know if that was common.   On 15-Sep2021, the patient had chest cold characterized by chest congestion, tightness, cough, white phlegm and heaviness.  At the time of the report, event was ongoing as the patient was not feeling well (Malaise) (onset: unknown date in 2021, latency: unknown).   The patient was treated with azithromycin (Zithromax z-pak), methylprednisolone (Medrol) and a nebulizer for Lower respiratory tract infection and not reported for rest.  Outcome was unknown for pain in extremity, hepatic enzyme increased, injection site swelling, injection site pain and not recovered / not resolved for rest.  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, UNK
Symptoms: Chills, Myalgia, Sleep disorder
Clinical narrative: down for 24 hours chills; Aches and pain; Slept till 4 pm in afternoon; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (down for 24 hours chills), MYALGIA (Aches and pain) and SLEEP DISORDER (Slept till 4 pm in afternoon) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Breast cancer.    The patient's past medical history included Foggy feeling in head (not so much a big deal), Queasy (Queasiness has eased off and comes and goes, does not limit her daily activities.), Fatigue (Periods of fatigue 2-6 hours after taking medication) and Sneezing. Previously administered products included for Flu: INFLUENZA (Flu shoot) on 02-Oct-2021. Past adverse reactions to the above products included No adverse event with INFLUENZA. Concurrent medical conditions included Allergic reaction (Increase in seasonal allergies). Concomitant products included LETROZOLE for an unknown indication.   On 13-Sep-2021, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (down for 24 hours chills), MYALGIA (Aches and pain) and SLEEP DISORDER (Slept till 4 pm in afternoon). At the time of the report, CHILLS (down for 24 hours chills), MYALGIA (Aches and pain) and SLEEP DISORDER (Slept till 4 pm in afternoon) had resolved.        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.   No concomitant medication information was reported.  No treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (gave him an empty vial or used syringe, so they revaccinated him) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (gave him an empty vial or used syringe, so they revaccinated him) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (gave him an empty vial or used syringe, so they revaccinated him) and NO ADVERSE EVENT (No adverse event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication 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. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not reported.  The patient and his wife was fully vaccinated as of early April.  The patient's side effect included fever, body aches and chills after the second Moderna shot, all normal and way more tolerable than actually getting COVID.  No treatment information was provided by the reporter.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Joint swelling, Night sweats, Oedema, Vaccination site erythema
Clinical narrative: Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm; Fatigue; Mild swelling, itching, and redness of left upper arm; mild swelling, itching, and redness of left upper arm; Nightsweats; Bilateral ankle sweling; Edema ,unspecified; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Nightsweats), JOINT SWELLING (Bilateral ankle sweling), OEDEMA (Edema ,unspecified), VACCINATION SITE SWELLING (Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm) and FATIGUE (Fatigue) 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.     The patient's past medical history included High cholesterol, Migraine, Shortness of breath, Heart rate abnormal in 2016, Chronic back pain and Depression. Concurrent medical conditions included Hypertension, Fibromyalgia, Neuropathy, Bipolar disorder, Drug allergy (Ultram (tramadol)), Drug allergy (Sulfonamides allergy), Drug allergy (Savella) and Drug allergy (metoproplol). Concomitant products included ARIPIPRAZOLE (ABILIFY), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FAMOTIDINE, SIMVASTATIN, PROPRANOLOL HYDROCHLORIDE (PROPANOLOL HYDROCHLORIDE), OMEPRAZOLE, PROMETHAZINE and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced NIGHT SWEATS (Nightsweats), JOINT SWELLING (Bilateral ankle sweling), VACCINATION SITE SWELLING (Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Mild swelling, itching, and redness of left upper arm) and VACCINATION SITE ERYTHEMA (mild swelling, itching, and redness of left upper arm). In 2021, the patient experienced OEDEMA (Edema ,unspecified). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at an unspecified dose and frequency and TRIAMCINOLONE at a dose of topical, one application two times a week for 10 days. At the time of the report, NIGHT SWEATS (Nightsweats), JOINT SWELLING (Bilateral ankle sweling), VACCINATION SITE SWELLING (Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Mild swelling, itching, and redness of left upper arm) and VACCINATION SITE ERYTHEMA (mild swelling, itching, and redness of left upper arm) outcome was unknown and OEDEMA (Edema ,unspecified) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm; Fatigue; Mild swelling, itching, and redness of left upper arm; mild swelling, itching, and redness of left upper arm; Nightsweats; Bilateral ankle sweling; Edema ,unspecified; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Nightsweats), JOINT SWELLING (Bilateral ankle sweling), OEDEMA (Edema ,unspecified), VACCINATION SITE SWELLING (Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm) and FATIGUE (Fatigue) 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.     The patient's past medical history included High cholesterol, Migraine, Shortness of breath, Heart rate abnormal in 2016, Chronic back pain and Depression. Concurrent medical conditions included Hypertension, Fibromyalgia, Neuropathy, Bipolar disorder, Drug allergy (Ultram (tramadol)), Drug allergy (Sulfonamides allergy), Drug allergy (Savella) and Drug allergy (metoproplol). Concomitant products included ARIPIPRAZOLE (ABILIFY), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FAMOTIDINE, SIMVASTATIN, PROPRANOLOL HYDROCHLORIDE (PROPANOLOL HYDROCHLORIDE), OMEPRAZOLE, PROMETHAZINE and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced NIGHT SWEATS (Nightsweats), JOINT SWELLING (Bilateral ankle sweling), VACCINATION SITE SWELLING (Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Mild swelling, itching, and redness of left upper arm) and VACCINATION SITE ERYTHEMA (mild swelling, itching, and redness of left upper arm). In 2021, the patient experienced OEDEMA (Edema ,unspecified). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at an unspecified dose and frequency and TRIAMCINOLONE at a dose of topical, one application two times a week for 10 days. At the time of the report, NIGHT SWEATS (Nightsweats), JOINT SWELLING (Bilateral ankle sweling), VACCINATION SITE SWELLING (Swelling at covid-19 injection site/ mild swelling, itching, and redness of left upper arm), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Mild swelling, itching, and redness of left upper arm) and VACCINATION SITE ERYTHEMA (mild swelling, itching, and redness of left upper arm) outcome was unknown and OEDEMA (Edema ,unspecified) was resolving.            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: Cough, Headache, Malaise
Clinical narrative: Cough/mucous production that is greenish; did not feel good; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough/mucous production that is greenish), MALAISE (did not feel good) and HEADACHE (Headache) 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 first 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 COUGH (Cough/mucous production that is greenish), MALAISE (did not feel good) and HEADACHE (Headache). At the time of the report, COUGH (Cough/mucous production that is greenish), MALAISE (did not feel good) and HEADACHE (Headache) had not resolved.            No information on concomitant medication were reported. No treatment details 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 19-Aug-2021: significant  Live Follow up appended. Narrative added.
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Occasional Constipation), DIARRHOEA (Occasional Diarrhea) and PAIN IN EXTREMITY (Sore arm) 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 Crohn's disease. Concurrent medical conditions included Crohn's disease (Moderate to severe adult crohn's disease). In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. On an unknown date, the patient experienced CONSTIPATION (Occasional Constipation), DIARRHOEA (Occasional Diarrhea) and PAIN IN EXTREMITY (Sore arm). At the time of the report, CONSTIPATION (Occasional Constipation) and DIARRHOEA (Occasional Diarrhea) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Patient had no known allergies. No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of SORE ARM was not provided. The reporter's causality for the event(s) of OCCASIONAL CONSTIPATION with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of OCCASIONAL DIARRHEA with HUMIRA(ADALIMUMAB) 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She had no reaction to the first 2 doses other than being extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (She had no reaction to the first 2 doses other than being extremely tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot 022M20A and Lot-019B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (She had no reaction to the first 2 doses other than being extremely tired). At the time of the report, FATIGUE (She had no reaction to the first 2 doses other than being extremely tired) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. Patient had no reaction to the first 2 doses other than being extremely tired.  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-2021-368416 (Patient Link).
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: revaccination with different covid vaccine; interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (revaccination with different covid vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (revaccination with different covid vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, COVID-19 IMMUNISATION (revaccination with different covid vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   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.