chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lightheaded; Arms, upper chest, face, and eyelids became red; Felt tingling all over skin like she was going to get hives; Felt tingling all over skin like she was going to get hives; low grade fever; This is a spontaneous report from a contactable pharmacist.   A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9269), via an unknown route administered in the right arm, on 22Mar2021 (at the age of 50-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 from Mar2020 and hives in the past due to unspecified antibiotic. The patient did not have concomitant medications. Patient was vaccinated on 22Mar2021. Symptoms started the same day at 16:00. Patient felt lightheaded, her arms, upper chest, face, and eyelids became red; she felt tingling over her skin like she was going to get hives. These events were assessed as medically significant. Later in call the caller mentioned the patient also had a low-grade fever (non-serious).  Patient never erupted into hives or had any itching. The patient was treated for diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC). Symptoms lasted about 24 hours and were gone the next day. However, the patient was considered recovered from the events 'lightheaded', 'arms, upper chest, face, and eyelids became red', and 'felt tingling all over skin like she was going to get hives' in Apr2021 (duration of the events was 21 days); the patient had recovered from the event 'low grade fever' on unknown date in 2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9269), via an unknown route administered in the right arm, on 17Apr2021 at single dose to completed COVID-19 immunisation.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the events Dizziness, Erythema , Paraesthesia Urticaria and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Burning/itching of skin. Next morning, rash appeared and I went straight to doctor at the advice of a family member.
As I was administering the vaccine, the patient stated: "I feel" and then fainted on me. Her husband and I kept trying to get her to talk to us, she was squeezing my hand as we talked, I ran an alcohol pad under her nose. We got her to open her eyes a few times and decided to call 911. She was breathing and I could feel her pulse. 911 had us lay her on the floor where she started to come to and mentioned how bad her vertigo was before I gave the shot. She also said her blood pressure was really low this morning and didn't want us to call the news as she didn't want to be on the news
This is an observation study case, initially received on 08-Nov-2018, concerns a 30-year-old, adult pregnant female, subject of body mass index: 20.2, weight: 121.2 lbs and height: 65 in, enrolled in a prospective observational safety study. The subject had an obstetrical history of ectopic pregnancy and spontaneous abortion. The subject had no maternal/paternal history with major congenital malformations. The father did not receive any medications prior to conception. The subject had not used tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included Herpes simplex virus infection (since an unspecified date). The concomitant medications included PNV, Valacyclovir HCL for herpes simplex infection. The subject's last menstrual period date was 19-Mar-2018 and the type of pregnancy was reported as singleton. On 18-May-2018, the subject underwent cystic fibrosis mutation analysis and no major congenital malformations were revealed. On 12-Jun-2018, the first trimester screening test was performed, and no major congenital malformation was noted. On 06-Jul-2018, maternal serum alpha-fetoprotein (MSAFP) serum markers analysis performed showed no major congenital malformation. On 13-Aug-2018, anatomic scan was performed, and no major congenital malformation was noted. On 01-Oct-2018, the patient (28 weeks of gestational age) was administered non-company suspect TDAP vaccine (dose, route of administration, batch number, expiry date and anatomical location: not reported). On 17-Oct-2018 (30 weeks gestational age), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF41708, dose, route of administration, expiry date and anatomical location: not reported). On an unspecified date in 2018, the subject underwent ultrasound which revealed echogenic cardiac foci which was not as bright as bone. At the time of this report, the outcome of the event was unknown. The subject's estimated date of delivery was reported as 24-Dec-2018.
First dose: Sore left arm; This is a spontaneous report from a contactable 34-years-old female consumer(patient).  A 34-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 23Aug2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Aug2021, after the vaccination, the patient experienced a sore left arm right away. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (23Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
She got her vaccine, her arm was hurting that day and that night, a little red around it.  Then it continued to grow and grew a marker and it grew outside of that circle and went to the ER, on 7/2/22.  They looked at the arm, saw that she was having an allergic reaction, gave her IV Benadryl, Pepcid for her stomach, Toradol for the pain, and then they did blood work, her potassium was low and they gave her sodium chloride packets.  They did an EKG on her as she was stressed as well as a chest x-ray, which they did cool compresses on the right arm.  The arm was swollen and getting worse, and she was told to continue the Benadryl at home.  The arm was then getting worse and by Tuesday it was more swollen, the redness was more and the area was going down toward the elbow and is red and swollen.  When she went back the 2nd time saw that her arm was swollen, etc., and did the Benadryl through the IV.  They did blood tests and it showed common cold (rhinovirus).  They gave her Tylenol and gave her Prednisone IV as well as 40 mg for 4 days at home.  She is still having the cold symptoms with her nose, throat, hurting ear, eyes are watery.  Her arm is still swollen, red down from middle of arm down to the elbow, but does not have it up top.  She called her infectious provider and saw her and said that it was a reaction and not an infection.  Every day she hopes that it would be less swollen.  Her skin is red and now really does not know if she is protected.  She is still not feeling "herself", having cramps/pain in her legs due to low potassium and has a call to her doctor for that.   She has had had 3 COVID vaccines and now cannot get the 2nd booster due to this reaction and feels she will have to wait 4 months to get that one.
Subsequently post vax, the pt developed a rash. Unspecified medical attention was sought.
Day after vaccine: Swelling lymph nodes under left arm and clavicle. Fever/chills, fatigue. Lasting 3 days. Day four after vaccine: vertigo. Lasting three days so far.
EAR ACHE; LARYNGITIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old female. Initial information was processed along with the additional information received on 16-JUL-2021 and 19-JUL-2021. The patient's weight was 137 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user and non smoker and also the patient was healthy. The patient experienced drug allergy when treated with codeine for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and  expiry: unknown) dose was not reported, 1 total administered on  05-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-JUL-2021, the patient underwent a covid-19 test and on 14-JUL-2021, the results came as positive (suspected clinical vaccination failure and suspected covid-19 infection). It was reported that the patient's covid-19 symptoms started with an ear ache, scratchy throat and laryngitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure, ear ache and laryngitis was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality Complaint -90000186156.; Sender's Comments: V0:20210733616-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
warm,  where the shot went in; hard, where the shot went in; Swollen, where the shot went in; good size red circle where the shot went in; red circle around the injection site, swollen and hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm,  where the shot went in), VACCINATION SITE INDURATION (hard, where the shot went in), VACCINATION SITE SWELLING (Swollen, where the shot went in), VACCINATION SITE ERYTHEMA (good size red circle where the shot went in) and VACCINATION SITE PAIN (red circle around the injection site, swollen and hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL and METOPROLOL for Blood pressure high.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (red circle around the injection site, swollen and hurting). On 02-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm,  where the shot went in), VACCINATION SITE INDURATION (hard, where the shot went in), VACCINATION SITE SWELLING (Swollen, where the shot went in) and VACCINATION SITE ERYTHEMA (good size red circle where the shot went in). At the time of the report, VACCINATION SITE WARMTH (warm,  where the shot went in), VACCINATION SITE INDURATION (hard, where the shot went in), VACCINATION SITE SWELLING (Swollen, where the shot went in) and VACCINATION SITE PAIN (red circle around the injection site, swollen and hurting) had resolved and VACCINATION SITE ERYTHEMA (good size red circle where the shot went in) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information in response to events was not provided.
body aches; Shivering; Swollen eyes; face is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: EYE SWELLING (non-serious) with onset 25Jan2023, outcome "unknown", described as "Swollen eyes"; SWELLING FACE (non-serious) with onset 25Jan2023, outcome "unknown", described as "face is swollen"; PAIN (non-serious), outcome "recovering", described as "body aches"; CHILLS (non-serious), outcome "recovering", described as "Shivering". Therapeutic measures were taken as a result of pain, chills. Additional information: caller got the Pfizer COVID booster vaccine and had a reaction last night and this morning, which caller stated is normal, always has this reaction, which caller clarified is that caller always has body aches and shivering for a little bit. When caller took medicine, no product name provided, the body aches and shivering reduced. Woke up with swollen eyes this morning, under eyes, on top of eyes, and face is swollen, really swollen around eyes.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This non-serious spontaneous case, initially received from other health professional on 26-Sep-2018, concerns an adult, pregnant, female pregnant patient of unspecified age. On an unspecified date, the pregnant patient was administered FLUCELVAX QIVc (batch number: 252659, expiry date: 31-May-2019, dose, route of administration and anatomical location: not reported). No adverse event was reported.
pt recvd vax & 4 hrs later devel dizziness & diaphoresis; pt was admitted to hosp w/dx of sinus bradycardia;
Upon removal of needle, child complained "I'm feeling dizzy", child jerked, then vomited.
APPROXIMATELY 12 HOURS AFTER IMMUNIZATIONS WERE ADMINISTERED CHILD DEVELOPED VIOLENT VOMITING, ACHINESS, WEAKNESS & CHILLS.  DEVELOPED FEVER  OF 103PO LATER DURING EVENING OF 12/20. GIVEN TYLENOL/MOTRIN FOR FEVER.  SXS SPONTANEOUSLY RESOLVED 24 HOURS AFTER ADMINISTRATION OF VACCINES.
SORE ARM; This spontaneous report received from a patient via a company representative via social media concerned a 75 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm (dose number in series 2). It was reported that, "I got the J&J vaccine and booster. I had a sore arm but other than that no side effects. Still wear my mask and the only gathering I have is my family whom all of us got vaccinated at the same time. I am almost 75 years old and believe in being vaccinated. This virus is the worst I have seen". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium
Swollen - red - hot at area of injection site of pneumo shot. Pt. unable to move arm d/t pain. Pt has arm in sling.
Extreme body aches, headache, fatigue, nausea,  chills, fever, lasting about 36 hours
78 y.o. 1/19/1944    Admit Date:  7/3/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: AKI (acute kidney injury)   Relevant Inpt Dx: Principal Problem:   AKI (acute kidney injury) Active Problems:   Chronic combined systolic and diastolic heart failure   COVID-19 virus infection   Diarrhea   Type 2 diabetes mellitus, without long-term current use of insulin   Essential hypertension       HPI:   Hospital Course:   This 78 year old man was admitted with covid and rhabdomyolysis on 6/29.  He did improve and went home.  He returned the next day with diarrhea and AKI.  He was treated with ivf and he has done well.  He no longer has diarrhea and his creatinine today is normal at 0.8.  He will follow up with pcp.            Consults:   IP CONSULT TO SOCIAL WORK IP CONSULT TO SOCIAL WORK     Disposition:  home   Discharge Condition:  fair
COVID 19 Treatment/Testing positive for covid; COVID 19 Treatment/Testing positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2 NOS), on 24Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/Testing positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Testing positive for covid with headache. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Sedation, Myalgia, Arthralgia & Nausea Vomiting  Narrative:
feel like somebody hit me  with a baseball bat, body ache low grade fever for 5 days
Vision lost for a half hour, hard time breathing, felt faint, joints aching for hours, lost of appetite for a couple hours.
This spontaneous prospective pregnancy report as received from a 25 year old female consumer, refers herself. The patient had no medical history or concurrent conditions. On 28-FEB-2014, the patient was vaccinated with the first dose of (oka/merck) VARIVAX (dose not reported), route reported as injection. No co-suspect therapies were reported. Concomitant therapies included unspecified prenatal vitamins. The patient reported that she received (oka/merck) VARIVAX while being pregnant. The patient became pregnant with Last menstrual Period (LMP) of 26-FEB-2014 and Estimated Date of Delivery (EDD) of 03-DEC-2014. It was reported that no treatment was given for the event and no lab diagnostic studies were performed. At the time of the report, the pregnancy outcome and the outcome of vaccine exposure during pregnancy were unknown. It was reported that (oka/merck) VARIVAX was not reintroduced and that the patient sought medical attention (office visit). Additional information has been requested.
injection site pain; redness at injection site; swelling; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On an unknown date, the patient received Bexsero and MENACTRA. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Bexsero.  Additional case details were provided as follows: The age at vaccination was not reported. The patient was given Bexsero and Menactra in same arm and pain, redness and swelling was reported after injection.
MODERNA COVID-19 VACCINE EUA  FEVER, ALTERNATING CHILLS/SWEATS, BODY ACHES, HEADACHE
This is a spontaneous case, initially received on 20-Sep-2018, reported by other non-health professional (consumer), concerning a 34-year-adult, female pregnant patient. The patient had 1 previous pregnancy and had no history of still birth/miscarriage or birth defect/congenital anomaly in previous pregnancy. The patient had no paternal medical history (hereditary disease). The patient's husband received unspecified medication prior to conception. The patient's historical drugs included allergy medications for grass allergy and oral contraceptives for an unknown indication. The patient's current condition included grass allergy. The concomitant medication included prenatal vitamins for an unknown indication. The patient's last menstrual period (LMP) date was 05-May-2018. It was reported that, it was patient's second pregnancy. The gender of the infant was reported as female. There was no defect or adverse finding from the prenatal test. On 20-Sep-2018, at 19 gestational weeks, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252661, expiry date: 31-May-2019) (explicitly coded as vaccine exposure during pregnancy). At the time of this report, the patient and foetus had not experienced any adverse events. The patient's estimated delivery date (EDD) was reported as Feb-2019. The reporter assessed the case as non-serious. Follow-up received from other non-health professional on 25-Oct-2018: The reporter refused to provide the requested information. Hence, this case was considered as lost to follow-up.