chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; This is a spontaneous report from a contactable consumer (wife). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on 08May2021 as first dose, single dose for COVID-19 immunization. The patient's medical history was not reported. The patient has no concomitant medications. The patient experienced fever on an unspecified date. The outcome of the event was not recovered; patient still has fever after 8 days. It was reported that they don't have health insurance, and in the hospital they didn't want to prescribe anything other than Tylenol and Ibuprofen. At the clinic where the patient got the vaccine, the reporter was recommended to call one of the phones on the papers they were given after the vaccine and that the reporter could get medical assistance there. The reporter just wanted to get medical assistance for the patient (her husband).  Information on the lot/batch number has been requested.
Diagnosed with bullous pemphigoid three months later. She had never experienced this before and is concerned that it may have been associated with her COVID-19 vaccination.; She developed a sudden skin rash in Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (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: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization, reaction(s): "COVID-19", "Drug ineffective". The following information was reported: PEMPHIGOID (medically significant) with onset Apr2022, outcome "unknown", described as "Diagnosed with bullous pemphigoid three months later. She had never experienced this before and is concerned that it may have been associated with her COVID-19 vaccination."; RASH (non-serious) with onset Apr2022, outcome "unknown", described as "She developed a sudden skin rash in Apr2022". The events "diagnosed with bullous pemphigoid three months later. she had never experienced this before and is concerned that it may have been associated with her covid-19 vaccination." and "she developed a sudden skin rash in apr2022" required physician office visit. Therapeutic measures were taken as a result of pemphigoid, rash.  Clinical course: It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown prior vaccination the patient was diagnosed with COVID-19. She developed a sudden skin rash in Apr2022 and was diagnosed with bullous pemphigoid three months later. She had never experienced this before and is concerned that it may have been associated with her COVID-19 vaccination. Patient received treatment with prednisone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Angina; Blocked artery; Vasoconstriction in heart vessels; Chest pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANGINA PECTORIS (Angina) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement in 2020. Concurrent medical conditions included Hypercholesterolemia. Concomitant products included VITAMINS NOS for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced CHEST PAIN (Chest pain). On an unknown date, the patient experienced ANGINA PECTORIS (Angina) (seriousness criterion medically significant), ARTERIAL OCCLUSIVE DISEASE (Blocked artery) and VASOCONSTRICTION (Vasoconstriction in heart vessels). At the time of the report, ANGINA PECTORIS (Angina), ARTERIAL OCCLUSIVE DISEASE (Blocked artery), CHEST PAIN (Chest pain) and VASOCONSTRICTION (Vasoconstriction in heart vessels) outcome was unknown.            Patient's concomitant medications are cholesterol medications, statins, proton pump inhibitors. Treatment for the event included beta blockers and nitrates. Laboratory investigations performed on an unknown date included stress test whose result was not provided. On 31March2021 he received the second dose, and a few days after the vaccine he started having chest pain, had it for a while, didn't consult right away, and he finally went to the Emergency room on 8April2021 or 10April2021.  Company comment- Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected events of Angina pectoris and Arteria occlusive disease, a causal relationship cannot be completely excluded; however case causality is confounded by the increased risk of cardiovascular complications due to the patient's history of stent placement and hypercholesterolemia complicated by the advanced age. Non-serious events of Chest pain and Vasoconstrictions are possible manifestations of Angina pectoris and Arteria occlusive disease,   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected events of Angina pectoris and Arteria occlusive disease, a causal relationship cannot be completely excluded; however case causality is confounded by the increased risk of cardiovascular complications due to the patient's history of stent placement and hypercholesterolemia complicated by the advanced age. Non-serious events of Chest pain and Vasoconstrictions are possible manifestations of Angina pectoris and Arteria occlusive disease,
Presented with right hand/arm pain, numbness, and weakness since morning after receiving injection on ipsilateral side.  Workup and imaging confirmed acute arterial thrombosis of the right upper extremity requiring surgery and thrombectomy.
This spontaneous report as received from a 46 year old female nurse practitioner who also the patient refers to herself with stage 3c endometrial cancer which she was diagnosed with in December 2013. There were no drug reactions or allergies. On 28-JAN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot # J010332, expiration date 14-JAN-2015 0.5 ml, intramuscular, doctor recommended since she was receiving chemotherapy. Concomitant therapies included TAXOL, carboplatin and cyanocobalamin (also reported as VITAMIN B12). The patient reported that her right arm immediately hurt after receiving the PNEUMOVAX 23. She also reported that her right arm "still" hurt and that she was up "every hour" in the night due to the pain in her right arm and was unable to lay on her right arm. She stated that she had been taking either TYLENOL or ibuprofen "before bed" for the pain of her right arm. She reported that when she received chemotherapy and she was given an unspecified steroid on unspecified dates, her arm did not hurt for "10 days". The patient reported that she had a white blood count, red blood cell count, and enzymes drawn on 24-MAR-2014 and she stated that the results were "good". The patient did not see medical attention. The outcome of the event was not recovered. Additional information has been requested.
pt recv vax 8MAY97 & 9MAY pain started & pt had chills, fever & cont pain, w/blistering starting on 11MAY97;site now very red & painful w/large 13mm blister;TC to pt taken to ER 13MAY97 PM;c/o blisters arm, fever, T & arm red & painful;
Moderna COVID-19 Vaccine EUA Moderna first dose 9/02, following symtoms occured 7 days later on 9/09 Fever, redness, swelling at injection site, itchy, hot, hard raied area, Was told this was called Covid arm, told to use heat, take pain med, and if area gets bigger in circumference to go to urgent care. Went to urgent care 0n 9/11, prescribed antibiotic for cellulits
1 hour after vaccine to left arm, patient sitting watching television, noticed elbows and knees were warm, red, tingling, non-raised erythematous patches noted on knees and elbows.  Feet felt swollen with trace edema noted on exam.  No wheezing, chest tight.
pt admitted to hosp with sx of mild SOB, productive cough; found to be positive for COVID; treated with steroids; experienced A Fib; through course of hospitalization, pt's O2 requirements increased; O2 supplementation; pt's condition worsened; ICU; family requested DNR; eventually transitioned to comfort measures; he passed away in the hospital with Pneumonia due to COVID 19 listed as one of the causes of death per death certificate
Pain in the chest cavity that  progressively got worse  for a week and then got better in a week.
Patient has swelling and pain in her arm the same day. She then got chest pain in which she  to the hospital and had stress test done by cardiologist.
High fever and severe chills for about 48 hr. Also nausea and body aches and fatigue
Sore, hot, red, swollen area of upper outer right arm. 60x60 mm at the widest/longest sections of the irregular area where varicella vaccine given.
Vaccine given outside of age range. Vaxelis is approved through age five, patient is six years old. No adverse s/s reported. Nurse called mother who states patient has not had any s/s of adverse reaction.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion. Total of 173 doses/vials were given for LOT  070H21A.  Date the vial was initially stored in the refrigerator was reported as unknown.~  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document contain non-significant information was updated.
I donated blood 6 days after my booster. I became very dizzy for several hours, which lasted for about 24 hours and after 2days I still feel a little light headed. I have Donated blood 6 times in the past year and a half and I have never had any issue. I just thought I should report it in case it has happened to others after getting the vaccine.
Right after I was dizzy and lightheaded for a couple days. Extremely exhausted. Main issue is CONSTANTLY ITCHING Palms, feet, and random spots. Intense itching.
Pt receiving varicella vaccine. Seated through injection and felt fine. Walked up to front desk for follow up appt - sudden syncope - fell without injury. Woke, and steady heart rate and resp in 230 seconds. Fine to go home in 10 min.
gotten your vaccine & tested positive for Covid; 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 COVID-19 (gotten your vaccine & tested positive for Covid) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (gotten your vaccine & tested positive for Covid). At the time of the report, COVID-19 (gotten your vaccine & tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter
3RD DOSE COVID VACCINE GIVEN 10/25/21, #FH8028;  pt had a positive COVID test on 10/3/22 and received Paxlovid; later that evening, pt unresponsive; EMS called; CPR and defibrillated 2x before ROSC; intubated on mechanical ventilation; admitted; sent to cath lab; anoxic brain injury; transitioned to comfort care and removal of all support; pt passed away in the hospital
Pt recvd vax 1st & 2nd dose of Hep B vax (brand unspecified) & recvd 3rd, Engerix-B on 10MAY91; w/in 24 hrs of dose pt exp severe muscle weakness, & joint pain which moves around constantly; Seen by MD;
Patches of papules covering symmetric areas of both lateral thighs, with onset several hours after vaccination, and persistent at exam 1 week later.  Patient had similar but less widespread papules after 2 month vaccines.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's medical history was not reproted. On 17-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL lot # K008931, expiration date reported as 04-MAR-2017 (dose, route and site of administration were not reproted). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Onset of NEW moderate bilateral tinnitus 72 hours after 1st dose.  Onset of right pulsatile tinnitus  72hours after 2nd dose.  Moderate bilateral tinnitus is still present. Pulsatile tinnitus has decreased in both intensity and frequency.
Patient seen at Clinic 10 days after administration of Moderna vaccine. Vaccine given at pharmacy and as per patient symptoms of SOB/Chest discomfort started 2 to 3 days after second dose of vaccine 10/5/2021 and has not improved.  Patient was instructed to follow up at Emergency room for re-evaluation of her symptoms.
This case was reported by a consumer and described the occurrence of sluggishness in a patient who received BOOSTRIX. On 25th July 2015, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced sluggishness, fever and rash. On an unknown date, the outcome of the sluggishness was recovered/resolved and the outcome of the fever and rash were not recovered/not resolved. It was unknown if the reporter considered the sluggishness, fever and rash to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The patient developed sluggishness that lasted one week. On 8th September 2015, fever symptoms and rash were still present. medication attention was sought.
This spontaneous report as received from a nurse refers to a 6 month old female patient. Medical history and drug reactions/allergies were not reported. On 14-JAN-2013, the patient was vaccinated with VARIVAX lot # reported as J002319, first dose, (expiry date, dose and route not reported) concomitantly with MMR II (lot, dose and route not reported). On 24-JAN-2013, the patient experienced dime-size red spot that was not raised, at the injection site. The nurse was contacted (sought for medical attention). The outcome of the event was not reported. Additional information has been requested.
Patient says no reaction at injection site, but later in the afternoon, a rash developed on her legs. Different rashes began to appear on different areas of body from then on. She has seen her primary care and then allergist in regards to rashes.
Swelling in neck; He thinks it is his lymph nodes that started on Wednesday and the swelling has not gone down yet; This is a spontaneous report received from a contactable consumer or other non-health professional (patient). A 49-year-old male consumer received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Unknown) dose 1, Via an unspecified route of administration, administered in left deltoid on 29MAR2021 at 12:00 as a single dose for (at the age of 49 years old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior Vaccinations were none.  On Apr2021 he has had swelling in his neck started late Tuesday and late Wednesday, and it comes and goes and he thinks it is his lymph nodes that started on Wednesday and the swelling has not gone down yet. Treatment include he has been taking Advil and that seems to help. Outcome of the event were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headaches; This is a spontaneous report from a contactable Nurse (patient).  A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  on 28Dec2020 at 13:30 at single dose in left arm  for COVID-19 immunisation. Medical history included COVID-19 on an unknown date (prior to vaccination the patient was diagnosed with COVID-19). Since the vaccination, the patient was not tested for COVID-19. No known allergies to medications, food or other products. There were no concomitant medications. The patient experienced headaches on 29Dec2020 at 05:00 am. Event was non serious . No treatment given and patient recovered from the event in Dec2020. Information on the lot/batch number has been requested.
Injection right deltoid 2/12/08 AM.  By the night, arm sore.  2/13/08 AM stiff neck, right upper back muscles, right arm pain 8 of 10.  By PM right upper arm "hive" at site, red and swollen.  2/14/08 nausea, all over body aches, hive gone, arm sore to move.  Still feels sick, arm pain 2 of 10.
After injection, LOC for about 5-10 seconds, some shakiness, layed flat, mom at bedside, patient a/o x 3 after waking, pale, BP 82/48, PR 68, layed flat for at least 10 minutes 86/50, feels good, gradually sat up, drank water, left with mom ambulated well, no concerns, will monitor
Per non-clinic records, + history of DVT (3/2019 suffered acute LLE  DW with IVC filter placed), + history of GI bleed on heparin, small vessel CVA  Patient reported to local Hospital ER on 3 29/21 for evaluation of "worsening  dark discoloration on LLL" for the "last several weeks". US unable to show  definitive blood clots due to edema of lower extremity. Recommended to repeat  US in 5-7 days if continuing to have concerns. Recommended to elevate legs  frequently and f/u with wound care and PCP. On 4/15/21, Patient evaluated at  local Hospital ER d/t bilateral lower extremity edema. "ultrasound performed  prior to consultation shows no significant reflux in the superficial venous system  Chronic DVT was noted in bilateral femoral veins. In 2019 she suffered an acute  LLE DVT and an IVC filter was placed at that time. Since that time she has  experienced gradual worsening of the edema in her lower extremities. Symptoms  are more significant in the left lower extremity including heaviness and fatigue.  She is not on anticoagulation at this time. During consultation she denied pain,  achiness, restless legs, leg cramps, calf pain, chest pain, dyspnea or warmth in the  lower extremities. She does complain of bilateral lower extremity edema,  discoloration and skin thickening." Per ED Physician, 4/20, "Because of the  extensive nature of these DVTs she was encouraged to get a thrombectomy.  Thrombectomy was to be done as an outpatient and on a nonurgent basis. Patient  has an IVC filter and is not a candidate for anticoagulation as she has had a  massive GI bleed in the past per the patient. The patient denies chest pain or  shortness of breath
extremely itchy; huge rash around the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (extremely itchy) and INJECTION SITE RASH (huge rash around the vaccination site) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE PRURITUS (extremely itchy) and INJECTION SITE RASH (huge rash around the vaccination site). At the time of the report, INJECTION SITE PRURITUS (extremely itchy) and INJECTION SITE RASH (huge rash around the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication reported.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up was received and consent was declined.
Rash on arm, face, eyes.; Extreme itching; swollen eyes; Nose inflammation; Nose inflammation, itching and hardening; Nose inflammation, itching and hardening; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER 8733) via an unspecified route of administration in the left arm on 01Apr2021 at 12:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. The patient did not receive any medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 07:00, the patient experienced rash on arm, face, eyes, extreme itching and swollen eyes, nose inflammation, itching and hardening. The patient received treatment for the reported events which included Benadryl. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event rash on arm, face, eyes, extreme itching and swollen eyes, nose inflammation, itching and hardening was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Bruised arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruised arm) and VACCINATION SITE SWELLING (Swollen arm) 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 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Bruised arm) and VACCINATION SITE SWELLING (Swollen arm). At the time of the report, CONTUSION (Bruised arm) and VACCINATION SITE SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.