chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left eye began leaking profusely; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISCHARGE (left eye began leaking profusely) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE DISCHARGE (left eye began leaking profusely). At the time of the report, EYE DISCHARGE (left eye began leaking profusely) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The concomitant medications were not reported. Treatment medications were reported as some unknown eyedrops and eye medications.   This case was linked to MOD-2021-436213, MOD-2021-436265 (Patient Link).
Numbness, loss of grip strength, loss of feeling, tingling and pain on left side of body.  Effecting left arm and hand more than the left leg.  But also has same symptoms in left leg but not as severe as left arm/hand.   Excessive sweating, lack of concentration.
Pfizer-BioNTech COVID-19 Vaccine EUA Muscle aches, chills, high fever, headache, vaccine site soreness and redness, swollen lymph node under right arm after second vaccine dose. Took extra strength Tylenol 1000mg  as directed every 6 hours (limited to 6 pills in 24 hours). Fever peaked at 103 about 36 hours after vaccination, was back to normal at about 72 hours after vaccination. Headache, vaccine site soreness and redness, swollen lymph node under right arm persists 72 hours post vaccination.
Face felt tight around her mouth; Facial tingling; Diarrhea; Tiredness; Extreme chills; Aches; Headache; Nausea; A fever of 101; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN TIGHTNESS (Face felt tight around her mouth), PARAESTHESIA (Facial tingling), DIARRHOEA (Diarrhea), FATIGUE (Tiredness) and CHILLS (Extreme chills) in a 42-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 Type II diabetes mellitus.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Jan-2021, the patient experienced SKIN TIGHTNESS (Face felt tight around her mouth), PARAESTHESIA (Facial tingling), DIARRHOEA (Diarrhea), FATIGUE (Tiredness), CHILLS (Extreme chills), MYALGIA (Aches), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (A fever of 101). On 13-Jan-2021, PYREXIA (A fever of 101) had resolved. On 14-Jan-2021, DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved. On 23-Jan-2021, SKIN TIGHTNESS (Face felt tight around her mouth), PARAESTHESIA (Facial tingling), CHILLS (Extreme chills), MYALGIA (Aches) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided  by the reporter.  The patient endorsed that her blood sugars were 'all over the place' following the first vaccine administration.  Treatment information was not provided.   This case was linked to MOD-2021-038627 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Events patient experienced during first and second dose, patient's medical history, more details of patient and information about patient's HCP was also provided.
Approx. 16 hours after 2nd dose, along with fever/chills, I experienced extreme vertigo. For approximately 24 hours, any attempt to sit up or stand was met with extreme dizziness, head spinning vertigo, and vomiting. Still (3 plus weeks later) experiencing debilitating vertigo daily. Waiting for appointment with healthcare professional.
pt recv vax 19SEP97 & on 20SEP97 swollen face & itching 21SEP97;tachycardia (P120), n/v, erythematous plaques on arms & abd;epi, DPH, Pred given;19SEP97 feeling bad;
Immediately after receiving dose, patient began to feel dizzy, then had an emesis and felt sick to her stomach. Patient laid down down on exam table and vital signs were monitored for 15 minutes. After 15 minutes, patient stated she felt better and was able to sit up and walk around. Observed patient for 15 more minutes before she left.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with a single dose of RECOMBIVAX HB (dose, lot# and route of administration were not reported) that was exposed to 23F for unknown period of time. It was unable to determine how long the vaccine was exposed to this low temperature since the facility did not clear the minimum-maximum thermometer daily. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented with acute respiratory failure and shortness of breath from COVID-19 pneumonia. He improved with systemic steroids, anticoagulation. There was a questionable superimposed pneumonia so he completed course of antibiotics. He also completed course with Remdesivir. Pt also had new onset atrial fibrillation. V/Q scan showed possible PE. He was discharged home on oral steroids, anticoagulation once medically stable.
This spontaneous report as received from a 67 year old female patient with diabetes type 2, niacin allergy, oro allergy, erythromycin allergy, steroids allergy and beta blockers allergy. In February 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # unknown), 1 time vaccine, subcutaneous in the left arm. Concomitant therapies included JANUVIA, "DIAVION", high blood pressure medication, CRESTOR and vitamins (unspecified). On 15-APR-2013 the patient had gotten a rash around her neck that had "prickly heat". She also stated that since getting the ZOSTAVAX vaccine, she had a wart that had increased in size under her right armpit. The hospitalization listed (hospitalization date unknown) was because she had food poisoning, per the patient. The patient did not receive any treatment or seek any medical attention. The outcome of the events was unknown. Relationship between the events and ZOSTAVAX were unknown. Additional information is not expected.
My daughter passed out, and while passing out was shaking/trembling, a few seconds after given the HPV Vaccine (Gardasil).  Had terrible headaches afterwards.
swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after the first dose of COVID vaccine and they are very painful; Swollen lymph nodes around left clavicle and close to armpit and neck; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 08:00 at single dose for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took oxycodone and experienced allergy. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Dec2020 07:00 PM, the patient experienced swollen lymph nodes around left clavicle and close to armpit and neck, that happened 5 days after the first dose of COVID vaccine and they are very painful. The outcome of the events was recovering. No treatment was given to the patient for the events.
had a gout flare up, it lasted a week then went away but came back worse; Severe gout attack; Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose.; Sore arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (had a gout flare up, it lasted a week then went away but came back worse), GOUT (Severe gout attack), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose.) and VACCINATION SITE PAIN (Sore arm injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026621A and 049821A) for COVID-19 vaccination.     Concurrent medical conditions included Gout attack.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose.) and VACCINATION SITE PAIN (Sore arm injection site). On 23-May-2021, the patient experienced GOUT (had a gout flare up, it lasted a week then went away but came back worse). 23-May-2021, the patient experienced GOUT (Severe gout attack). The patient was treated with CELERY SEED EXTRACT at an unspecified dose and frequency; PRUNUS CERASUS (CHERRYXTRA) at an unspecified dose and frequency and APPLE CIDER VINEGAR ongoing since an unknown date for Gout attack, at an unspecified dose and frequency. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose.) had resolved. On 16-May-2021, VACCINATION SITE PAIN (Sore arm injection site) had resolved. On 26-May-2021, GOUT (Severe gout attack) had resolved. At the time of the report, GOUT (had a gout flare up, it lasted a week then went away but came back worse) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant Follow up received on 01/JUL/2021, added new events and updated treatment medications. On 06-Jul-2021: TCR form attached. Consent declined.
Information has been received from a nurse practitioner concerning a 38 month old female who on 4/1/2003 was vaccinated with a dose of varicella virus vaccine live. On 6/8/2005 the patient experienced approximately 50 maculopapular lesions on her extremities, trunk and face. She was afebrile. On 6/10/2005 the patient was seen in the office, some of her lesions were excoriated due to scratching. On 6/29/2005 the patient was seen in the office and presented with lesions on her arms and legs which were diagnosed as insect bites. Unspecified medical attention was sought. It was not known if laboratory diagnostic test were performed. At the time of the report the patient was not recovered. There was no product quality complaint involved. Information received on 6/29/2005 contained the following adverse experienced arthropod bite 6/29/2005.
Vaccine given 17 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 17 days post expiry) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 17 days post expiry). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 17 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395985 (Patient Link).
That evening (11/14) and the next day the pt experienced severe generalized weakness, that diminished over time lasting about 5 days.  Pt able to call for medical attention on 11/15 but refused transport to any medical facility as she was told all of her vitals were normal.  Pt was asked but did not experience any muscle pain, or fever, or Nausea or vomiting.
Chest pain developed in the location of the heart.  Was persistent but mild.   Pain was 2-3 on the 10 scale.  I assumed it was caused by work stress, mentioned to family to monitor.  I gave up coffee.  Pain persisted. Mentioned to sleep Dr at standing appointment April 22 later. He said follow up with primary care.  I got into see my PC,  April 24.  He said my heart sounded OK but decided I should be taken to the emergency room for  enzyme test. Also did xray.  ER doc ruled out heart attack and said likely inflammation of chest wall or bones in the area.  Pain still persists. Got referral to cardiologist and did SPECT test June 8th.  results pending.
a 3 year old 10 month old child received only 0.25 mL of Fluzone Quad instead of 0.5; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 3 years old female patient (also reported as 3 year old 10 month or 4 year) who received only 0.25 ml of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of 0.5 ml, which was an intended dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was taken.  On 01-Feb-2019, the patient received a 0.25 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6315UA via unknown route in left thigh.  It was of actual medication error due to vaccine underdose.  It was unknown if any adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Within a week or so after the vaccine I begin experiencing pain under my right arm.  It eventually got to the point under both arms were swollen like holding fluid to the point I had to buy a bra extender.  Lymph nodes under arms were painful and hard, it went to the lymph nodes under my breasts and my right breast enlarged immensely.  I started doing arm exercises trying to get the fluid to move out and succeeded keeping it down enough I could put my arm down without being in a lot of pain.
pt recvd 6 doses of Engerix-B & has not seroconverted;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021 at 1:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:02 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 75.81.  Concomitant products were not provided.  On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 6 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  Vial was stored on cooler 1, on 28-Mar-2021, Excursion duration At 8 AM: 43, 9 AM: 38, 10 AM: 35, 11 AM: 44, 12 AM: 44, 1PM: 41, 2 PM : 46, 3 PM: 46, 4 PM: 42 and 5 PM : 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Irregular menstrual cycle; This is a spontaneous report from a contactable Health Care Professional (patient).   A 28-year-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), the first dose, on an unspecified date, at single dose, in the left arm and the second dose on an unspecified date (Lot. 59267-1000-03) at single dose, in the left arm, for COVID-19 immunisation. Relevant medical history and concomitant medications were none. The patient had not experienced Covid-19 prior vaccination. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks of vaccination. No known allergies were reported. On 17May2021, the patient had irregular menstrual cycle. No treatment received. Clinical outcome of the adverse event was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19.  Follow-up attempt have been completed and no further information is expected. The lot number is not available despite follow-up attempts made.
Right side heart failure (which he has been hospitalized before); Has low indicators of heart disease (no cholesterol and no triglycerides); heart failure was associated with his COPD; 2 types of cancer; on of the being lung cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 02Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 02), administration date: Jan2021, for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "2 types of cancer"; LUNG NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "on of the being lung cancer"; CARDIAC FAILURE (hospitalization), outcome "unknown", described as "Right side heart failure (which he has been hospitalized before)"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Has low indicators of heart disease (no cholesterol and no triglycerides)"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "heart failure was associated with his COPD". The patient underwent the following laboratory tests and procedures: total lung capacity: 65 %, notes: COPD with a lung capacity of 65%.  Clinical Course: The patient had comorbidities. He was aware that the efficacy of the vaccine wanes after 6 months and wished to get information on if he would be able to get a second booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
rash around esrs and neck; 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 RASH (rash around esrs and neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash around esrs and neck). At the time of the report, RASH (rash around esrs and neck) outcome was unknown.            no treatment information was provided no concomitant medication were reported
Red, hot and swollen within hours, and has continued to spread. Now it is from his left shoulder almost to his elbow, and has spread onto his chest. Mom marked the edge at 9 pm last night, and the redness is spreading another 3-4 cm past that on his arm and is almost full circumference on his arm. it is hard to move his arm and shoulder.