chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after the 2nd dose, they have been diagnosed with COVID19.; after the 2nd dose, they have been diagnosed with COVID19.; This is a spontaneous report from a contactable nurse reported for a patient. A 85-years-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection Batch/Lot number: Unknown) via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received BNT162B2 (COMIRNATY Formulation: Solution for injection Batch/Lot number: Unknown) via an unspecified route of administration on an unknown date as historical vaccine as dose 1, single for COVID-19 immunization. Reporter stated two patients (one male 85-years-old and second female 85-years-old) who already received first 2 doses of the Pfizer Biontech COVID19 vaccine. Reporter said that after the second dose, they have been diagnosed with COVID-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test diagnosed with COVID-19.   The lot number for [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE(Drug ineffective,Covid-19) The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202101383070 same reporter/drug/event, different pt
high pitched crying for 6 to 8 hrs; fever inc 101; swelling @ inj site;
On the evening of 3/2/2021 I started having severe chills and I developed a fever, both symptoms lasted 24 hours. Then on 3/4/2021 around 2:00 pm I broke out into hives from the chest up. I took Benadryl a couple times that day and I was symptom free on 3/5/2021.  After I recieved my second dose on 3/302021, I developed the same symptoms except the hives came on the same day and lasted two days.
Woke at 12:15 am with rectal temp of 101.4. No discomfort at site.
Swelling and redness with pain and itching to injection site 24 hours after vaccine administration.
Developed fever to 102F for 2 days , following Prevnar Vaccine. Within 2 weeks developed now-in set moderate eczema
1447: Post vaccination approximately 20 minutes.  Patient had c/o dizziness, feeling shaky, nauseated, and light headed.
Muscle aches; Feeling of fainting; Stomach upset; nausea; Headache; Flu Like Symptoms; Sweats; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, 16 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, sweating, chills, muscle pain, felt faint, upset stomach, nausea and headache. In May 2019, the outcome of the influenza-like symptoms, sweating, chills, felt faint, upset stomach, nausea and headache were recovered/resolved. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, sweating, chills, muscle pain, felt faint, upset stomach, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient who was a pharmacist.  The patient received Shingrix in the left arm. He stated that about 16 hours after receiving the vaccine he experienced flu like symptoms, sweats, chills, muscle aches, felt like fainting, stomach upset, nausea and headache. It was intense for the next 6 hours. He recovered from everything 24 hours later except the muscle ache which he was still experiencing. The reporter did not consent to follow-up. No further details were provided.
pt recvd vax & exp red face, stiff body, limp body & pale rash on arms; was not seen by MD; sx resolved in 1 hr;
Information has been received from a physician concerning a 12 yr old pt who was vaccinated with a dose of varicella virus vaccine live. In approx July 2005, recently, the pt experienced breakthrough varicella with a fever and a lot of lesions. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available. Additional information has been requested.
11JAN92 pt began having hives break out & skin was red & blotchy on face & thighs; temp elevated 103; mom took pt to ER & was given DPH & Epi-hives continued to break out until 14JAN92; MD started pt on Pediazole on 13JAN92;
pt was admitted for eval of sz 6JUL93 w/admitting dx of partial complex sz, generalized sz, probable idiopathic epilepsy, r/o anatomic etiology;
Pain, heat, erythema, edema; WBC: 16000, afebrile;
I have never had any food allergies, but I ate roasted peanuts yesterday for the first time since my covid vaccines. I had anaphylaxis, throat swollen shut, swollen lips tongue and face. shortness of breath, runny nose, coughing, vomiting, chest pain about 15 minutes after eating.
Right arm pain , numbness, weakenss, starting about 2 days after injection. Had reduced grip strength and numbness along dorsal part of hand. Symptoms are improving now, about 2 weeks post vaccine.
Extreme muscular pain everywhere. Chills  ? could not get warm. Severe pain at injection site which limited use of left arm.  Symptoms lasted 15 hours
extreme headache/severe headache; my left hand has swelling pretty significantly and it is in a lot of pain; my left hand has swelling pretty significantly and it is in a lot of pain; Joint pain; my left hand had swollen up significantly and it is itching very badly, red, warm to touch; my left hand had swollen up significantly and it is itching very badly, red, warm to touch; my left hand had swollen up significantly and it is itching very badly, red, warm to touch; This is a spontaneous report from a contactable consumer. This 49-year-old female consumer (patient) reported for herself that: A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: unknown, NDC/UPC number and Expiry Date: Unknown), via an unspecified route of administration on 28Apr2021 as DOSE 2, SINGLE (at the age of 49-years-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included pantoprazole. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0158), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization.  On 29Apr2021 after the second dose of vaccination, the patient experienced extreme headache/severe headache, left hand has swelling pretty significantly and it is in a lot of pain, Joint pain, left hand had swollen up significantly and it is itching very badly, red, warm to touch. It was reported that, When probed for the concern, Patient stated she just had the second vaccine shot yesterday and had extreme headache today and her left hand has swelling pretty significantly and it is in a lot of pain so patient did not know whether she should just ice it or is it a known side effect and it is in pain even if she try to make a fist it hurts so I just do not know whether she should be going to ER or whether it will just by. Patient woke up early this morning with very severe headache, joint pain and my left hand had swollen up significantly and it is itching very badly, red, warm to touch and the swelling seems to keep growing and I can barely close my hand. So patient was assuming it the reactions, patient did not know whether Patient should be going to the doctor or is it a known side effect. It was very painful. Patient took treatment Excedrin Migraine which helped a little bit but she still have the headache but in the right side of the head. The outcome of the events my left hand has swelling pretty significantly and it is in a lot of pain was not recovered, while the outcome of other events was reported as unknown.  No follow-up attempts were needed. Information about lot/batch number could not be obtained.
3/31-hives , back legs , lower back.   now hives , localized to injection site, nausea    her   dr recommended Zyrtec and Claritin
No other AE; a 10 month old patient was administered their 4th dose of VAXNEUVANCE too early; This spontaneous report was received from a nurse referring to a 10-month-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 16-AUG-2023, the patient was vaccinated with the fourth dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (lot #: W036242, expiration date: 01-OCT-2024; strength, dose, and route of administration were not reported) for prophylaxis, which was too early (inappropriate schedule of product administered). No symptoms reported.  No other adverse events (AE) (no adverse event).
PATIENT WAS GIVEN COVID VACCINE AFTER BEYOND USE DATE OF 12/17/2022
Chronic cough, hoarseness, phlegm, tinnitus, dizziness, anorexia.
Severe inflammatory reaction - swelling throughout entire body, (Most visibly noticeable  in hands), severe neck and back pain,  Face and upper chest became very red, band-Aid from vaccine uncharacteristically for a patient left severe redness persistent after more than 24 hours from 2nd shot.
while the lymph node swollen was declare i also feel some chest pain during the day since the day following the vaccination.  it may be due to the swollen lymph node because the injection was on left arm hence the swollen is my left armpit but i have been feeling pressure in my chest and lot of pain coming from the swollen armpit.
AFIB after the first vaccine on the same day within a few hours. Then I had the second dose and at that point I was having Afib (Atrial Fibrillation several times a week and long in duration and took 4-6 hours to recuperate. Condition worsened. Doctor put me on flecainide to control the Afib since about late November 2021. Cardiologist seen for this. Since I began flecainide, I have not had a full-blown AFIB. In January 2022 I feel like my heart races some times. Since that never happened before, my cardiologist said we will discuss that again on my next visit.
hallucinating; blood sugar very low; very dizzy; disorientated; I wasn't able to hold conversation; very scary; sweaty; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 37-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0217), dose 2 via an unspecified route of administration in arm left on 25Jun2021 at 17:00 (at the age of 37-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included liver disease from an unknown date and unknown if ongoing. The concomitant medications of the patient included rifaximin (XIFAXAN), propranolol (PROPRANOLOL), bupropion hydrochloride (WELLBUTRIN), celecoxib (CELEXA [CELECOXIB]) and ursodiol (URSODIOL) all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0178), via an unspecified route of administration in arm left on 04Jun2021 at 15:00 (at the age of 37-years-old) as single dose for COVID-19 immunisation. 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 not been tested with covid-19. The patient experienced reported that on 25Jun2021 at 18:00 approx 30 min after injection, while shopping, I became very dizzy, sweaty and disorientated. I wasn't able to hold conversation and was rolling and running in circles. I did not know where I was and was hallucinating, very scary and all happened very quickly. Was taken to ER for observation, was told my blood sugar very low. I've never had glucose problems and am not diabetic. The patient underwent lab tests and procedures which included blood glucose decreased was low on 25Jun2021. Therapeutic measures were taken as a result of events that included ate food and observed. The outcome of all the events was reported as resolving.
50/50 millimeter red, painful lump on right upper arm. Given sub-Q. Patient c/o headache and fatigue that started the evening of 2/27/07. Patient advised to alternate warm and cold packs 2-3 times daily and use OTC Benedryl as directed. She will call to report on 3/2/07.
Subject collapsed during Gym period at school. Appeared to black out momentarily, fell and does not remember doing so. Arms and legs shook while he was down. Appeared to observers as if he were having a seizure. Felt OK, if bewildered, when he came to. Wanted to stay in school. No fever or other reported physical sensations.
At  18 hours severe fatigue, aches, usual post vaccine symptoms, but at 48 hours had about 2-3 hours of non-stop SVT?s, fluttering, racing, palpitations. I was coincidentally wearing a heart monitor for this issue which had been occurring infrequently so it was captured on that. My doctor assured me by e-mail that it wasn?t ?significant?. Didn?t feel that way, was very scary but I did not go to ER as I was already on a monitor and felt it would be a ?hassle? there.
Patient passed out after receiving his first Pfizer covid19 vaccination. He fell to the ground, but does not believe he hit his head. He came to not too long after and stated that this has happened before when he has dealt with needles. Other symptoms include patient feeling clammy. His BP was taken three times and read 97/59. 156/108, and 134/94.
Patient has a 5 in. x 4 in. raised, red, hot reaction around the injection site.  He was given the injection of varicella vaccine in his Lt arm SQ at 1000/AM on 9-2-09 and he noticed the reaction this morning -9-3-09.
Information has been received from a certified nurse midwife for the pregnancy registry for GARDASIL, concerning an approximately 19 year old female with diabetes, papilloma viral infection, successful smoking cessation at 27 weeks of gestation and thalassaemia minor and a history of depression, who in October 2007, was vaccinated with the first dose of GARDASIL and subsequently was determined to be pregnant.  It was reported the patient has no previous pregnancies.  On 31-Jan-2008, the patient was placed on therapy with prenatal vitamins (unspecified), PRN for the pregnancy and the treatment of anemia.  Other therapies used in pregnancy included as follows:  On 31-JAN-2008, the patient was placed on therapy with metronidazole, 500 mg twice a day for the treatment of bacterial vaginosis.  On 04-FEB-2008, the patient was placed on ferrous sulfate, 325 mg twice a day for the treatment of anemia.  On 04-FEB-2008, an ultrasound was performed and was found within normal limits.  On 07-FEB-2008, therapy with metronidazole was discontinued.  On 28-APR-2008, the patient was placed on therapy with glyburide, 2.5 mg twice a day for the treatment of gestational diabetes.  On 09-MAY-2008, an ultrasound was performed and was found within normal limits.  On 27-MAY-2008, an ultrasound was performed and a biophysical profile of 8/10 was found.  Diagnostic laboratory tests during pregnancy also included a blood work for iron studies and a group B strep screen found positive.  The patient's LMP was on 24-SEP-2007.  On 11-JUN-2008, the patient delivered a 39 weeks healthy baby girl with an apgar score of 8 at one minute and 10 at 5 minutes.  The estimated date of delivery was 18-JUN-2008.  On 14-NOV-2008, the patient had a 5 month old visit and well child examination was found.  Baby's growth and developed was considered normal.  The baby was recommended for flu vaccine and scheduled for follow-up in two months.  No further information is available.
This study case was received from the investigator in ae trial on 22 February 2012. A 36 year-old male subject whose family history included a parent with CAD and a grandparent that had a bypass at the age of 40 was found to have on 28 August 2009 other, chest pain 19 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported). On 22 July 2009, the subject received ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). The subject arrived by ambulance and presented with L (left) substernal, sharp CP (chest pain) which was reported as 5/10 and SOB (shortness of breath). The subject's pain resolved after the first dose of NG (nitroglycerin). Relevant diagnostic testing revealed: serial ECGs and enzymes are negative, CXR- no PE, no effusion. The subject was admitted to the hospital for continued monitoring (dates not reported). The ER (emergency room) summary included: "IMPRESSION: CP; unstable angina, cardiac rub". Diagnostic testing included: ECG1 : 19days post vaccination Abnormal ECG, possible inferior MI; ECG2 : 19days post vaccination after NG given, no CP, NSR, no stenosis; ECG3: 20days post vaccination NSR (normal sinus rhythm), pain free; ECG4: 20days post vaccination NSR with sinus arrhythmia, pain free; ECG5: 20days post vaccination NSR, subject sleeping, pain free, normal ECG; ECG6: 20days post vaccination NSR, CP 1/10, with mild dyspnea, normal ECG; ECG7: 20days post vaccination NSR with sinus arrhythmia, CP 3/10, normal ECG; ECG8: 20days post vaccination after NG given, no CP, no SOB, no STEMI, Sinus bradycardia, otherwise normal ECG; inpatient stress test 20days post vaccination maximum HR of 166bpm (90.2%). No significant ST segment elevation, normal stress test. Laboratory data included: Troponin I "12:59 19days post vaccination negative; 16:02 19days post vaccination negative; 00:45 20days post vaccination negative. The subject remained on AD (active duty). Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
pt recv vax & pt exp a dec burning sensation @ the inj site, & pain @ the inj site;no further details were provided;
Cannot raise her arm up due to pain; Lump the size of a golf ball at the injection site; swelling seemed to be moving down her left side; Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side; Red at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump the size of a golf ball at the injection site), SWELLING (swelling seemed to be moving down her left side), MOBILITY DECREASED (Cannot raise her arm up due to pain), VACCINATION SITE PAIN (Sore arm) and LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 14-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump the size of a golf ball at the injection site), SWELLING (swelling seemed to be moving down her left side), LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) and VACCINATION SITE ERYTHEMA (Red at the injection site). On 17-Mar-2021, the patient experienced MOBILITY DECREASED (Cannot raise her arm up due to pain). The patient was treated with IBUPROFEN on 12-Mar-2021 at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MASS (Lump the size of a golf ball at the injection site) and VACCINATION SITE PAIN (Sore arm) was resolving and SWELLING (swelling seemed to be moving down her left side), MOBILITY DECREASED (Cannot raise her arm up due to pain), LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) and VACCINATION SITE ERYTHEMA (Red at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.
double vision, lightheaded, feels flush, passes out, lethargic, headaches, tingling in fingers, abdominal pain, drop in blood pressure, disoriented, fatigue, turns blue
Pt received Pnu-Imune 23 and Fluvirin on the same day into the right deltoid. Within 24 hours post vax the pt developed a fever of 104F which persisted for several days then decreased to 102F. She was afebrile as of 10/01/1998, but had a cough productive for white sputum and had chest congestion. It is recommended that these two vaccines be injected into separate sites when they are administered concomitantly. Follow up information information indicated that the vaccinee had a history of small cell lung adenocarcinoma which was treated with Taxol and carboplatin. Pt was treated with Tylenol which relieved her symptoms of fever, chest congestion and productive cough. The fever resolved after 48 hours and all symptoms are stated as having resolved 4 days post onset. Reporting physician strongly believes that the pts reaction may be related to injection of influenza and pneumo vax simultaneously.
No reaction on day vaccines were administered 10/15/15 on morning 10/16/15 patient called to report her left cheek seemed swollen and some numbness on left cheek and her back was itchy. No other symptoms. No reaction at injection site.
Patient was administered ZOSTAVAX vaccine on March 5, 2018. Patient mentioned she developed rash on day 3 post-vaccination. Patient sought medical treatment on March 12. Patient arrived to pharmacy on March 12 with prescriptions from medical treatment. Patient explained what occurred. Her emergency room doctor diagnosed her with varicella. She received treatment for varicella. Patient explained her rash was itchy.
T 104.9 F, convulsions X1, marked alteration in LOC-child not responsive to mother.
Headache; Right neck got stiff; Felt shaky; Felt little nauseous; Itchy all over; Tired; This is a spontaneous report from a contactable consumer (patient's sibling). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 06Mar2021 (at the age of 53 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included allergies to sulpha. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. The patient was a little nervous about getting her second shot due to experienced adverse events. Probably will take off. Immediately after vaccination (06Mar2021), the patient got a headache and right neck got stiff and felt shaky. Within 15 minutes (06Mar2021), the patient felt little nauseous. The patient didn't get rash but after a few hours (06Mar2021), she started feeling itchy all over and tired. The patient also indicated that she feels fine today (08Mar2021). No treatment was received for the adverse events. The patient recovered from the events in Mar2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.