chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Throat tightness
Clinical narrative: BODY ACHES; SORE THROAT; TIGHTNESS IN THE THROAT; CHILLS; FATIGUE; BAD HEADACHE; FEVER; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight was 185 pounds, and height was 73 inches. The patient's concurrent conditions included: pollen allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient was healthy and had no medical conditions. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced sore throat. On 02-NOV-2021, the patient experienced tightness in the throat. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced fatigue. On 02-NOV-2021, the patient experienced bad headache. On 02-NOV-2021, the patient experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, chills, bad headache, and fever, and the outcome of sore throat, tightness in the throat and fatigue was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a 60 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that on 15-MAR-2021, the patient was in the hospital with an other blood clot and had to be given 2 units of blood. The number of hospitalization days were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211110749-COVID-19 VACCINE AD26.COV2.S-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: 1 day of not feeling well; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (1 day of not feeling well) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (1 day of not feeling well). At the time of the report, MALAISE (1 day of not feeling well) had resolved.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired booster dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date/03Sep2021 4 doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/03Sep2021 4 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/03Sep2021 4 doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/03Sep2021 4 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided  Treatment medications were not provided  Reported that 68 doses of the Moderna Covid-19 Vaccine (all from lot 939902) used after the vials were stored in the refrigerator for 30 days.Dose administered after 30-day Use By Date.  Date the vial was initially stored in the refrigerator: 02-Aug-2021.  Date of vaccine administration was reported as 03 Sep  2021- 4 doses, 20 Sep 2021 -4 doses, 01 Oct 2021- 7 doses,18 Oct 2021 -4 doses , 25 Oct 2021 -19 booster doses, 26 Oct 2021- 14 booster doses, 27 Oct 2021 -19 booster doses.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received on 28-Oct-2021 contains: Date(s) of administration of vaccine added and updated in I narrative.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Illness, Influenza like illness
Clinical narrative: really really sick; Like a really bad flu; dizzy; Fever of temperature 101; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really really sick), INFLUENZA LIKE ILLNESS (Like a really bad flu), DIZZINESS (dizzy), PYREXIA (Fever of temperature 101) and HEADACHE (Terrible headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (really really sick), INFLUENZA LIKE ILLNESS (Like a really bad flu), DIZZINESS (dizzy), PYREXIA (Fever of temperature 101) and HEADACHE (Terrible headache). At the time of the report, ILLNESS (really really sick), INFLUENZA LIKE ILLNESS (Like a really bad flu), DIZZINESS (dizzy), PYREXIA (Fever of temperature 101) and HEADACHE (Terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of temperature 101.         No concomitant medications were reported.  No treatment medications were reported.  The patient states she had no symptoms after the first two shots.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received : It contains No New Information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: really really sick; Like a really bad flu; dizzy; Fever of temperature 101; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really really sick), INFLUENZA LIKE ILLNESS (Like a really bad flu), DIZZINESS (dizzy), PYREXIA (Fever of temperature 101) and HEADACHE (Terrible headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (really really sick), INFLUENZA LIKE ILLNESS (Like a really bad flu), DIZZINESS (dizzy), PYREXIA (Fever of temperature 101) and HEADACHE (Terrible headache). At the time of the report, ILLNESS (really really sick), INFLUENZA LIKE ILLNESS (Like a really bad flu), DIZZINESS (dizzy), PYREXIA (Fever of temperature 101) and HEADACHE (Terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of temperature 101.         No concomitant medications were reported.  No treatment medications were reported.  The patient states she had no symptoms after the first two shots.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received : It contains No New Information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Fatigue, Headache, Vaccination site erythema, Vaccination site pain
Clinical narrative: caliber bone swelling; tender arm; swellown arm; redness; headache; some fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE SWELLING (caliber bone swelling), VACCINATION SITE PAIN (tender arm), VACCINATION SITE SWELLING (swellown arm), VACCINATION SITE ERYTHEMA (redness) and HEADACHE (headache) in a 70-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.     Concurrent medical conditions included Drug allergy (cephalosporins).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE SWELLING (caliber bone swelling), VACCINATION SITE PAIN (tender arm), VACCINATION SITE SWELLING (swellown arm), VACCINATION SITE ERYTHEMA (redness), HEADACHE (headache) and FATIGUE (some fatigue). At the time of the report, BONE SWELLING (caliber bone swelling), VACCINATION SITE PAIN (tender arm), VACCINATION SITE SWELLING (swellown arm), VACCINATION SITE ERYTHEMA (redness), HEADACHE (headache) and FATIGUE (some fatigue) outcome was unknown.            no concomitant medications were reported. no treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: caliber bone swelling; tender arm; swellown arm; redness; headache; some fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE SWELLING (caliber bone swelling), VACCINATION SITE PAIN (tender arm), VACCINATION SITE SWELLING (swellown arm), VACCINATION SITE ERYTHEMA (redness) and HEADACHE (headache) in a 70-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.     Concurrent medical conditions included Drug allergy (cephalosporins).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE SWELLING (caliber bone swelling), VACCINATION SITE PAIN (tender arm), VACCINATION SITE SWELLING (swellown arm), VACCINATION SITE ERYTHEMA (redness), HEADACHE (headache) and FATIGUE (some fatigue). At the time of the report, BONE SWELLING (caliber bone swelling), VACCINATION SITE PAIN (tender arm), VACCINATION SITE SWELLING (swellown arm), VACCINATION SITE ERYTHEMA (redness), HEADACHE (headache) and FATIGUE (some fatigue) outcome was unknown.            no concomitant medications were reported. no treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Thirst
Clinical narrative: waking up thirsty the night of the shots; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (waking up thirsty the night of the shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE in January 2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced THIRST (waking up thirsty the night of the shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered ). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered ) had resolved. At the time of the report, THIRST (waking up thirsty the night of the shots) outcome was unknown.      No concomitant information was reported. No treatment information was reported. Patient stated that patient never came down with COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Slight fever; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Slight fever) and MYALGIA (Body aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PYREXIA (Slight fever) and MYALGIA (Body aches). In August 2021, PYREXIA (Slight fever) and MYALGIA (Body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  No treatment medication reported by reporter.   This case was linked to MOD-2021-315935, MOD-2021-368432 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: lymph node was really swollen in left arm where I got shot; diarrhea; nauseated; vomiting; chilling really bad; fever/101°F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHILLS (chilling really bad), PYREXIA (fever/101°F), NAUSEA (nauseated) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A, 019B21A and 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced CHILLS (chilling really bad) and PYREXIA (fever/101°F). On 27-Oct-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nauseated) and VOMITING (vomiting). On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph node was really swollen in left arm where I got shot). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 28-Oct-2021, DIARRHOEA (diarrhea), CHILLS (chilling really bad), PYREXIA (fever/101°F), NAUSEA (nauseated) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph node was really swollen in left arm where I got shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Body temperature: 101°f (High) High.         No concomitant medication provided. Patient date of birth includes 28-OCT year was unknown
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vomiting
Clinical narrative: lymph node was really swollen in left arm where I got shot; diarrhea; nauseated; vomiting; chilling really bad; fever/101°F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHILLS (chilling really bad), PYREXIA (fever/101°F), NAUSEA (nauseated) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A, 019B21A and 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced CHILLS (chilling really bad) and PYREXIA (fever/101°F). On 27-Oct-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nauseated) and VOMITING (vomiting). On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph node was really swollen in left arm where I got shot). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 28-Oct-2021, DIARRHOEA (diarrhea), CHILLS (chilling really bad), PYREXIA (fever/101°F), NAUSEA (nauseated) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph node was really swollen in left arm where I got shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Body temperature: 101°f (High) High.         No concomitant medication provided. Patient date of birth includes 28-OCT year was unknown
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vomiting
Clinical narrative: full body aches; I got my Moderna Covid-19 booster in the afternoon. I've been throwing up; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (full body aches), VOMITING (I got my Moderna Covid-19 booster in the afternoon. I've been throwing up), PYREXIA (fever) and CHILLS (chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced MYALGIA (full body aches), VOMITING (I got my Moderna Covid-19 booster in the afternoon. I've been throwing up), PYREXIA (fever) and CHILLS (chills). At the time of the report, MYALGIA (full body aches), VOMITING (I got my Moderna Covid-19 booster in the afternoon. I've been throwing up), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-368946 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in his injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in his injection site arm.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in his injection site arm.). At the time of the report, VACCINATION SITE PAIN (soreness in his injection site arm.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-369491, MOD-2021-369492 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Significant followup appended, patient's gender confirmed.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspepsia, Fatigue, Pain in extremity
Clinical narrative: Heart palpitations, heart racing, dizziness, heart burn, weakness, fatigue, arm soreness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations, heart racing, dizziness, heart burn, weakness, fatigue, arm soreness.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Colonoscopy, Computerised tomogram, Culture stool, Impaired work ability
Clinical narrative: Severe abdominal pain, nausea, and vomiting requiring hospital visits, office visits, colonoscopy. Have missed several days of work due to this.. Entyvio infusion increased to every 4 weeks from every 8 weeks.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea, Vomiting
Clinical narrative: Severe abdominal pain, nausea, and vomiting requiring hospital visits, office visits, colonoscopy. Have missed several days of work due to this.. Entyvio infusion increased to every 4 weeks from every 8 weeks.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Self esteem decreased
Clinical narrative: Left side numb for over a week. My butt hole keeps twitching. Loss of self respect
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Contusion, Erythema, Headache, Lymph node pain
Clinical narrative: Redness; soreness; headache; sore/swollen lymph nodes under left arm pit; left side of left breast was sore and was purple and looked bruised.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Skin discolouration
Clinical narrative: Redness; soreness; headache; sore/swollen lymph nodes under left arm pit; left side of left breast was sore and was purple and looked bruised.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Computerised tomogram abnormal, Urine analysis abnormal, Vaginal haemorrhage
Clinical narrative: BREAKTHROUGH VAGINAL BLEEDING: 10/8/21, 11/2/21, 11/5/21
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy cervix, Carbohydrate antigen 125, Full blood count, Postmenopausal haemorrhage, Red blood cell sedimentation rate
Clinical narrative: Post Menopausal Bleeding - have now had two consecutive menstrual Period. I am three years post menopause. This is highly unusual and all other potential causes have been ruled out
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan vagina
Clinical narrative: Post Menopausal Bleeding - have now had two consecutive menstrual Period. I am three years post menopause. This is highly unusual and all other potential causes have been ruled out
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrioventricular block second degree, Cardiac monitoring, Cardiac pacemaker insertion, Cardiac stress test, Echocardiogram
Clinical narrative: Symptoms were missing heart beats while exercising. Diagnosed with type 2, second degree AV Block, requiring pacemaker.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extrasystoles, Scan myocardial perfusion
Clinical narrative: Symptoms were missing heart beats while exercising. Diagnosed with type 2, second degree AV Block, requiring pacemaker.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood 25-hydroxycholecalciferol, Cardiac flutter, Cardiac monitoring, Chest discomfort, Dizziness
Clinical narrative: hours after receiving vaccination heart started racing, chest was heavy, started having to take intensely deep breaths.  Moments of heart fluttering/palpitations and pounding along with some dizziness and nausea for 5 days before seeking treatment
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Nausea, Palpitations, Respiration abnormal
Clinical narrative: hours after receiving vaccination heart started racing, chest was heavy, started having to take intensely deep breaths.  Moments of heart fluttering/palpitations and pounding along with some dizziness and nausea for 5 days before seeking treatment
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Palpitations
Clinical narrative: Systemic: hair loss. palpitations-Medium
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site pain, Rash
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Severe, Additional Details: pt contracted shingles shortly after. after md visit, per pt md states shingles was triggered by vaccine
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: 10 days after the shot I got basic flu like symptoms. Body ache, mild head ache, chills, fatigue, but NO fever. These symptoms lasted about four hours.
Age: 9.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No other AEs or PQC reported. No Additional information available.; received PROQUAD and VARlVAX at same visit; This spontaneous report was received from a medical assistant and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # U006312, expiration date 24-AUG-2022, 0.5 milliliter, subcutaneously (SQ) and varicella virus vaccine live (oka/merck) (VARIVAX) lot # U007471, expiration date 08-MAR-2023, 0.5 ml, SQ (formulations, concentrations, dose numbers and anatomical locations were not reported) for prophylaxis. Both the vaccines were administered at the same visit (overdose). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles vaccine gave shingles/ Suspected vaccination failure; shingles; 4 months of severe pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved.   The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that Shingles vaccine gave him/her shingles and had 4 months of severe pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Near death experience
Clinical narrative: practically kill me; This case was reported by a consumer via  interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2017, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by patient. The age at vaccination was not reported. The patient stated that, he/she got the shingles shot and it practically killed him/her. The follow-up would not possible as no contact details were available.
Age: 57.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash, Rash erythematous, Rash papular
Clinical narrative: itchy bumps legs and elbows, itching; itchy bumps legs and elbows; red bumps legs and elows, rash started to get worse this afternoon; soreness at the injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 24th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2021-2022 season. In October 2021, 24 hrs after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced injection site pain and injection site erythema. On 27th October 2021, the patient experienced itchy rash, papular rash and red rash. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the itchy rash, papular rash and red rash were not recovered/not resolved.   The reporter considered the injection site pain and injection site erythema to be related to Shingrix. It was unknown if the reporter considered the itchy rash, papular rash and red rash to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patient for himself. The also stated that he got flu shot at the same time, but in his left arm. The patient Shingrix shot in his right arm on the evening. The patient stated that 24 hours after the shot, he had redness and soreness at the injection site. The redness traveled down his arm for about 48 hours, but the redness and soreness in his arm (right arm) had resolved. The patient stated he started to see some mild, slightly itchy red bumps on his legs and elbows.  The patient now called to report that the rash started to get worse this afternoon. The patient stated that there were more red bumps effecting both his arms and the rash was itching.  The patient had no further data on either of the shots. Spoke per PI about side effects.  Referred him to health care professional and gave medical disclaimer.  He stated that if he started to have issues breathing, to go immediately to local emergency room. The reporter did not consent to follow-up. Refer linked case US2021224261, wife's case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224261:Wife's case
Age: 57.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Rash pruritic
Clinical narrative: itchy bumps legs and elbows, itching; itchy bumps legs and elbows; red bumps legs and elows, rash started to get worse this afternoon; soreness at the injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 24th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2021-2022 season. In October 2021, 24 hrs after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced injection site pain and injection site erythema. On 27th October 2021, the patient experienced itchy rash, papular rash and red rash. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the itchy rash, papular rash and red rash were not recovered/not resolved.   The reporter considered the injection site pain and injection site erythema to be related to Shingrix. It was unknown if the reporter considered the itchy rash, papular rash and red rash to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patient for himself. The also stated that he got flu shot at the same time, but in his left arm. The patient Shingrix shot in his right arm on the evening. The patient stated that 24 hours after the shot, he had redness and soreness at the injection site. The redness traveled down his arm for about 48 hours, but the redness and soreness in his arm (right arm) had resolved. The patient stated he started to see some mild, slightly itchy red bumps on his legs and elbows.  The patient now called to report that the rash started to get worse this afternoon. The patient stated that there were more red bumps effecting both his arms and the rash was itching.  The patient had no further data on either of the shots. Spoke per PI about side effects.  Referred him to health care professional and gave medical disclaimer.  He stated that if he started to have issues breathing, to go immediately to local emergency room. The reporter did not consent to follow-up. Refer linked case US2021224261, wife's case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224261:Wife's case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: WEIGHT LOSS; DIARRHEA; FATIGUED; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug sensitivity when treated with amoxicillin/clavulanic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 13-OCT-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 13-OCT-2021, the patient experienced body aches. On 13-OCT-2021, the patient experienced diarrhea. On 13-OCT-2021, the patient experienced fatigued. On 13-OCT-2021, the patient experienced headache. On 20-OCT-2021, the patient experienced weight loss. On 29-OCT-2021, Laboratory data included: Blood test (NR: not provided) clean, and Stool analysis (NR: not provided) negative, very watery. Treatment medications (dates unspecified) included: loperamide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 15-OCT-2021, had not recovered from diarrhea, and the outcome of fatigued and weight loss was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: WEIGHT LOSS; DIARRHEA; FATIGUED; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug sensitivity when treated with amoxicillin/clavulanic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 13-OCT-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 13-OCT-2021, the patient experienced body aches. On 13-OCT-2021, the patient experienced diarrhea. On 13-OCT-2021, the patient experienced fatigued. On 13-OCT-2021, the patient experienced headache. On 20-OCT-2021, the patient experienced weight loss. On 29-OCT-2021, Laboratory data included: Blood test (NR: not provided) clean, and Stool analysis (NR: not provided) negative, very watery. Treatment medications (dates unspecified) included: loperamide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 15-OCT-2021, had not recovered from diarrhea, and the outcome of fatigued and weight loss was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling
Clinical narrative: RIGHT KNEE STARTED SWELLING; DIFFICULT TO WALK; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 29-OCT-2021, the patient experienced right knee started swelling. On 29-OCT-2021, the patient experienced difficult to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right knee started swelling and difficult to walk was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: Severe headache, body aches, chills, fever, nausea, severe weakness including fainting episodes x 18 hours. Weakness, nausea ongoing still.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: Severe headache, body aches, chills, fever, nausea, severe weakness including fainting episodes x 18 hours. Weakness, nausea ongoing still.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Loss of personal independence in daily activities, Paraesthesia, Tremor
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Right arm tingling & shaking all the way down to patient's hand making it difficult to perform day-to-day activities
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; reporting due to age requirement. Vaccine not yet approved for child's age.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Extra dose administered, Lip swelling, Peripheral swelling, Skin indentation
Clinical narrative: I received my booster vaccine on Monday, 11/1/2021. On Tuesday morning, 11/2/2021, I woke up with full body hives, as well as on Wednesday, Thursday and Friday. Each day got progressively worse. I take Xyzal and it seemed to subside but the red marks remain. Today, 11/5/2021, I woke at 3 am and took a Xyzal 5mg. I had to take another at 6 am because I started to swell - my hands are so swollen I can leave dents in them. I have hives all over my entire body including my palms, my ears and scalp. The lower half of my face is swollen including my lower lip. I am thinking about going to the emergency room.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Urticaria
Clinical narrative: I received my booster vaccine on Monday, 11/1/2021. On Tuesday morning, 11/2/2021, I woke up with full body hives, as well as on Wednesday, Thursday and Friday. Each day got progressively worse. I take Xyzal and it seemed to subside but the red marks remain. Today, 11/5/2021, I woke at 3 am and took a Xyzal 5mg. I had to take another at 6 am because I started to swell - my hands are so swollen I can leave dents in them. I have hives all over my entire body including my palms, my ears and scalp. The lower half of my face is swollen including my lower lip. I am thinking about going to the emergency room.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Faeces discoloured, Musculoskeletal pain, Myalgia
Clinical narrative: My left shoulder hurt for 6 or more months. Pain under right scapula. Generalized muscle aches and pains. My stool turned yellow. Abdominal bloated. Left foot pain.  I was having noise in my ears but did not think it needed treatment at the time.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: My left shoulder hurt for 6 or more months. Pain under right scapula. Generalized muscle aches and pains. My stool turned yellow. Abdominal bloated. Left foot pain.  I was having noise in my ears but did not think it needed treatment at the time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: 53 year female presented to vaccine clinic, scheduled for a Moderna booster. Reconciled past immunization records on system, pt had received 1st  dose (2/08/21) and 2nd dose (3/04/21) of Moderna and indicated to proceed with administration of 3rd dose. Pt received 0.5cc of Moderna on 10/25/21 @ 11:52, double the recommended volume of 0.25cc for booster. Pt did not have any allergic reaction or adverse event during 15 min monitoring period nor upon leaving.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Seizure like phenomena, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: seizure like symptoms-Severe, Additional Details: pt has hx of this event since birth from shots/blood draws
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 53 year male presented to facility vaccine clinic, scheduled for a Moderna booster. Reconciled past immunization records, pt had received 1st  dose (3/12/21) and 2nd dose (4/09/21) of Moderna and indicated to proceed with administration of 3rd dose. Pt received 0.5cc of Moderna on 10/25/21 @ 10:44, double the recommended volume of 0.25cc for booster. Pt did not have any allergic reaction or adverse event during 15 min monitoring period nor upon leaving.    Moderna Lot #11F21A, exp 1/19/2021
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blindness, Chest pain, Conjunctivitis, Dyspnoea
Clinical narrative: Chronic pink eye, blurred vision, vision loss, sore throat, earache,  sinus pressure, trouble breathing with chest pain, nasal issues, fatigue, muscle/joint pain
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Myalgia, Nasal disorder, Ophthalmological examination
Clinical narrative: Chronic pink eye, blurred vision, vision loss, sore throat, earache,  sinus pressure, trouble breathing with chest pain, nasal issues, fatigue, muscle/joint pain
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Paranasal sinus discomfort, SARS-CoV-2 test, Vision blurred
Clinical narrative: Chronic pink eye, blurred vision, vision loss, sore throat, earache,  sinus pressure, trouble breathing with chest pain, nasal issues, fatigue, muscle/joint pain
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Computerised tomogram abnormal, Fatigue, Inflammation
Clinical narrative: Initial flu like symptoms, continuing fatigue, pain in joints. Two months later, pleurisy symptoms, treated for pneumonia. In June, ER visit, pain on inspiration the same. In July, ER visit, same. Cat scan revealed pericarditis. Pericardial window performed. Post hospital discontinued Mesalamine which was also contributing to systemic inflammation.   As of today, joint pain and extreme fatigue and weakness continue.   GI Doctor calls this a "confounding event" as both the vaccine and Mesalamine could have worked together, but the cascade of effects started with the second vaccine.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Laboratory test, Painful respiration, Pericardial excision, Pericarditis
Clinical narrative: Initial flu like symptoms, continuing fatigue, pain in joints. Two months later, pleurisy symptoms, treated for pneumonia. In June, ER visit, pain on inspiration the same. In July, ER visit, same. Cat scan revealed pericarditis. Pericardial window performed. Post hospital discontinued Mesalamine which was also contributing to systemic inflammation.   As of today, joint pain and extreme fatigue and weakness continue.   GI Doctor calls this a "confounding event" as both the vaccine and Mesalamine could have worked together, but the cascade of effects started with the second vaccine.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Initial flu like symptoms, continuing fatigue, pain in joints. Two months later, pleurisy symptoms, treated for pneumonia. In June, ER visit, pain on inspiration the same. In July, ER visit, same. Cat scan revealed pericarditis. Pericardial window performed. Post hospital discontinued Mesalamine which was also contributing to systemic inflammation.   As of today, joint pain and extreme fatigue and weakness continue.   GI Doctor calls this a "confounding event" as both the vaccine and Mesalamine could have worked together, but the cascade of effects started with the second vaccine.