chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle pain; low grade fever; flu like symtoms; tiredness; 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), on 24Sep2021 as dose 3 (booster), single (Lot number: FF2587) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing); "Crohns disease" (ongoing). Concomitant medication(s) included: MESALAMINE oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing). Vaccination history included: pfizer/biontech (1st dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6201), administration date: 11Feb2021, for Covid-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Tiredness"; pfizer/biontech (2nd dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6206), administration date: 04Mar2021, for ovid-19 immunization, reaction(s): "Muscle pain"; pfizer/biontech (2nd dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6206), administration date: 04Mar2021, for Covid-19 immunization, reaction(s): "Low grade fever", "Tiredness"; Pfizer/biontech (2nd dose, Route of administration: Intramuscular, Anatomical location: Arm, Batch/Lot number: EN6206), for Covid-19 immunization, reaction(s): "Flu like symptoms". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 25Sep2021, outcome "recovered", described as "flu like symtoms"; PYREXIA (non-serious) with onset 25Sep2021, outcome "recovered", described as "low grade fever"; MYALGIA (non-serious) with onset 25Sep2021, outcome "recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 25Sep2021, outcome "recovered", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, influenza like illness, fatigue.  Additional information: No prior vaccinations (within 4 weeks). No patient's medical history. No relevant tests. No specific relevant test. Mild reaction to all covid vaccine. Including muscle pain, low grade fever, flue like symptoms, tiredness.
nausea; Shakiness; Extreme fatigue; headache; low-grade temp (under 101.4); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration, administered in the left arm on 06Mar2021 08:00 (at the age of 51-years-old), as dose 1, single for COVID-19 immunisation. Medical history included high cholesterol, and Known allergies: Penicillin, sulfa, latex, poison ivy. Concomitant medications included ascorbic acid (VIT C); ergocalciferol (VIT D); and unspecified vitamin B medication all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, shakiness, extreme fatigue, headache, and low-grade temp (under 101.4) on 06Mar2021 10:00. Events were reported as on and off for 80 hours. The patient underwent lab tests and procedures which included body temperature: under 101.4 fahrenheit (reported as low-grade temp, off and on, 80 hours so far) on 06Mar2021. No treatment was received and events did not result to either physician office or emergency room visit. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling of multiple left supraclavicular lymph nodes for 46 days; This is a spontaneous report from a contactable other hcp reporting for herself.     A 35-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Dec2020 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation  .  Medical history included gastrooesophageal reflux disease . Concomitant medication included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced swelling of multiple left supraclavicular lymph nodes for 46 days  on 30Dec2020 with outcome of not recovered.  Follow up information has been requested.
Information has been received from Sentrx and was assigned manufacturer report number MC200800078, concerning a 61 year old male who is a smoker and has a history of hyperlipidaemia, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA)/PCI and a family history of coronary artery disease who on 02-FEB-2008, was vaccinated IM into his right deltoid muscle with a 25 "ug" dose of pneumococcal 23v polysaccharide vaccine for pneumonia prevention. The patient experienced right arm cellulitis while enrolled in protocol TMC-CAN-05-02, a clinical trial comparing cangrelor to clopidogrel in subjects undergoing percutaneous coronary intervention (PCI). Other concomitant therapy included bivalirudin. On 31-JAN-2008, the patient was admitted to the hospital, enrolled in the study and underwent PCI. He received an intravenous bolus dose of the blinded study medication 5.8 ml on 01-FEB-2008 at 17:09, followed by an infusion of 95.48 mL from 17:11 to 19:15. Additionally, the patient received an oral dose of blinded study medication, four pre-procedure capsules on 01-FEB-2008 at 17:11 and four post procedure capsules on 01-FEB-2008 at 19:20. On 02-FEB-2008 at 13:00, the patient was discharged immediately after receiving the pneumococcal 23v polysaccharide vaccine. On 02-FEB-2008 at 13:30, the patient experienced right arm cellulitis. He developed redness and gradual swelling of the injection site and later in the day he developed fever and chills. Additional presenting symptoms included pain at the injection site, cough, myalgia, rash and anxiety. The patient presented back to the emergency room on 03-FEB-2008 for treatment. Laboratory tests performed included absolute neutrophil count of 10.2 Thou/uL and a white blood cell count of 12.4 Thou/uL. A blood culture was negative with no growth seen on a culture taken from the peripheral line on the right arm. The patient was treated with IV cefepime, 1 g bid from 04-FEB-2008 at 07:00 to 06-FEB-2008 at 07:00 and IV vancomycin, 1g every day on 04-FEB-2008 at 20:00 to 06-FEB-2008 at 12:15 for an infection in the right arm. Laboratory results normalized on 06-FEB-2008 with absolute neutrophils of 5.8 Thou/uL and WBC of 8.4 Thou/uL. On 13-FEB-2008, the event was considered to be resolved. This was originally reported by a physician. The reporting investigator considered the event to be probably related to the pneumococcal 23v polysaccharide vaccine and unrelated to the study medications. No further information is available.
injection site pain.; fever; entire body joint pain; muscle pain; This is a spontaneous report from a contactable other health care professional, the patient. A 60-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration in the left arm on 25Mar2021 at 19.00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) 20mg on every other day for an unknown indication and from an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200) via an unspecified route of administration in the left arm on 04Mar2021 at 19.00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any vaccines within four weeks prior to the COVID-19 vaccine. On 26Mar2021 at 15:00, the patient experienced injection site pain, fever, entire body joint and muscle pain. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, fever, body joint pain and muscle pain was resolved on  an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse refers to a patient of unknown demographics. On 02-SEP-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU (plaque-forming units) (dosing regimen unspecified). No concomitant medications were reported. On 02-SEP-2014, the patient received ZOSTAVAX that was reconstituted and left in a syringe for approximately one hour at an unspecified room temperature. No adverse symptoms reported. Outcome was unknown. Additional information has been requested.
Also received Moderna vaccine second dose on 5/7/21 and third dose on 11/29/21.  Since the first dose I have had ringing in my ear. a high pitched noise... I barely noticed it after the first shot and then by the third shot I noticed it was more constant. I now have it daily and it does not go away.  I have tmj. I did see an ENT for pain in my ear but was told the pain was the tmj.
had flu; Initial information received on 20-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp (non healthcare professional)  This case involves an unknown age and unknown gender patient who had flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for flu (Influenza immunisation).  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Not Recovered / Not Resolved for the event had flu.
Saturday 6:00 a.m. - tender arm at injection site.  12:00 p.m. felt dizzy for less than a minute and then passed out in the driveway attempting to get into the house.  I hit my face on both the foundation and a retaining wall (corner).  When conscious I got into the house, laid on the couch and couln't move for 7-8 hours.  I was nauseous, cramps in my rib cage and sweating profusely.  My clothes were soaked and the fan was blowing on me.  I was freezing and sweating but unable to move.  I couldn't get the phone on the table 12 inches away.  I was very dizzy and if I moved my eyes everything was spinning.
Pt received Pfizer COVID vaccine for second dose inadvertently when they should have received Moderna.  No adverse effects noted.
Patient states : Arm was painful right after injection on left arm and continued. Injection site pain worsened and went up to neck and down to elbow within the next day to neck day and a half. Within 2 days noticed decrease range of motion and pain persisted. Patient used a heat pack with some resolution in pain, but no tylenol or advil. At day 5, consulted with Dr through a video appointment about arm pain and told to continue to utilize heat pack if it helps. Patient told MD will start to take advil for pain, Md agreed to treatment.
Duplicate Flu Vaccine given during pregnancy; EDD 05/06/2018; Vaccines were given on 11/08/2017 &  01/25/2018; Called Patient and she stated she had no adverse reactions to the vaccines.
Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: Fainted as he was standing up after 2nd Pfizer shot (1st shot received elsewhere). He regained conciousness within 1 minute. He fell face down & we could see reness above nose & bleeding from nose (probably from the fall). He could sit up within minutes but continued to feel dizzy & "stomach hurt". His mom did not speak English, staff asked if should call 911 & pt said yes.  manager stayed with pt till 911 came & took over care for patient. Pt stated had no similar reaction to 1st.
About 12 hours after the vaccine (vaccine 3pm Friday night, first onset of symptoms 3am Saturday morning), I developed a tingling in one particular nerve in my left leg culminating with extreme sharp pain at one particular part of my foot (intermediate dorsal cutaneous nerve).  The pain was like being stabbed in the foot by an ice pick.  The tingling/pain repeated with a period of 15-30 seconds.  After talking to a doctor Saturday afternoon, I applied ice to the location and elevated the foot.  This provided some relief from the stabbing pain.  However as I slept that next night (Saturday night), the pain returned.  I got very little sleep both Friday night and Saturday night.  On Sunday, I tried lidocaine patches directly on the foot.  These patches were left over from some back pain I had last year.  The patches provided essentially complete relief from the stabbing pain throughout Sunday and Sunday night.  By Monday afternoon, the pain was gone without using the patches.  As I write this today, Tuesday, there is still a little minor tingling, but no stabbing pain.  Both my father and my grandmother had shingles at various times.  I was with them when they had it.  The pain they described from their cases of shingles matches exactly with what I felt, except their pain was not localized to just one place as mine was, but over a larger area.
Pt recv vax on 10/28/98;(8-10 hr post vax pt exp sore throat, swollen lip & inside of mouth
p/vax pt los consciousness;911 was phoned;when attempting to lie pt flat there was approx 5-10sec of sz activity;pt moved BP obtained regained consciousness;paramedics arrived-no transport;
This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline (Reference number: 492166-1325823943). A contactable consumer (consumer's father) reported for his female daughter as follows: "First of all, I suggest this email be recorded and sent to your legal department pursuant to the lawsuit which will be filed by my family/child (who at 12 months old) received a dose of PREVNAR as a vaccine to prevent Lymes disease. My child has not only had Lymes disease at a very young age, but continues to have it at age 15 and throughout her entire life with debilitating symptoms and many hospital visits. Your company removed this vaccine after a few short years and we know this to be responsible for our beautiful, otherwise healthy girl's, Lyme problems. Prior to contacting a high profile lawyer to handle our case on a pro-bono arrangement, we are giving your company the opportunity to settle this case in a clearly reasonable manner. It is unfortunate that you will probably fight this in court, but we are not going to stop fighting and letting the world know the true reasons this vaccine was taken off the market. This email is our first to you and your legal department and will be forwarded to our lawyer also, in the event that such a settlement is not immediately remedied, causing severe Lyme symptoms as well as arthritic conditions in an otherwise born healthy and beautiful baby girl. I expect an immediate response and my daughter is currently in the hospital again being treated with high doses of antibiotics. We know this is, and has been, the cause of her problems for years, but just found her 12 month old vaccination forms proving this vaccine was given to her by her pediatrician. We are tired of watching our daughter cry and suffer everyday from Lyme which she should have never been exposed to as a 12 month old child."
DEATH PATIENT RECEIVED VACCINE AT A VACCINE CLINIC AROUND 3 PM ON 4/12/22 AND WAS MONITORED FOR 15 MINUTES WITH NO ADVERSE EVENTS OBSERVED.  THE VACCINATING HEALTHCARE PROVIDERS RECEIVED A REPORT OF THE PATIENT'S PASSING AROUND 10 AM ON 4/13/2022.
Patient with 2 Emergency Department visits after vaccination.  (3.19.21 & 3.22.21) 3.19.21:   Symptoms:  Patient had the J&J vaccine on Tuesday, and felt fatigued on Wednesday. Today she is more short of breath than normal and states she has chest pain. Daughter has suggested an ambulance, but patient, who is A&O X 3, declines. Daughter will bring to ED for evaluation.    61-year-old female with history of asthma, sleep apnea, environmental allergies, and hypertension presents emergency department complaining of shortness of breath and cough that started this morning and midsternal chest tightness rating at a 7/10.  Sent home with prescriptions to manage cough, inhaler and steroid burst.   3.20.21 Office Visit:  Patient states Wednesday 03/17/21 morning cough and mild fatigue started. Thursday 03/18/21 patient had shortness of breath with exertion x2 days. Yesterday 03/19/21 patient went down the stairs and was having severe shortness of breath. Patient felt like she couldn't get enough air in. Patient was seen in ED 03/19/21 and prescribed cough medicine. Patient states cough is constant with intermittent coughing fits. Patient was tested for COVID-19 while in ED and results were negative Shortness of breath is still present, but is better after ED visit. Patient states she feels 50% better today 03/20/21. Patient has been using inhaler and prednisone. Patient is needing to move slower to compensate for shortnbess of breath. Cough is present still. Cough is deep and dry. Yesterday 03/19/21 cough was productive. Today 03/20/21 patient is getting a small amount of phlegm out and it is white in color. Denies fever. No known exposure to COVID-19. History of asthma, not much relief currently with inhaler. When shortness of breath is present, it takes patient about 20-30 minutes to recover. Intermittent wheezing with mild wheezing present currently. Tightness in chest is present and coughing makes it worse. Patient had COVID-19 in April of 2020.                       Any treatment So Far: ED visit, Inhaler, prednisone, and prescribed cough medicines               3.22.21:  Mon Mar 22, 2021 1722 This is a 60 year female presents for evaluation of shortness of breath.  Some been going on for about a week now.  She was just seen in the emergency department 3 days ago for same complaints.  At that time she had a cardiac workup that was unremarkable.  On initial evaluation here today she appears in no acute respiratory distress.  She has normal room air oxygen saturations.  Complete blood count shows a slight leukocytosis of 11.93 which may be elevated secondary to her current prednisone use.  About 4 positive relative normal limits.  Troponin was normal as was her proBNP.  COVID PCR was not detected.  CT angiogram thorax was negative for PE, pneumonia or other acute process.  Patient is notified of these findings.  She otherwise is discharged home with instructions follow up closely with primary care physician.
5/10/07 Telephone consult with patient stated nausea and extensive swelling at Tdap site (R) Deltoid. Described (L) sided numbness (L) leg and arm and buttocks, High fever, Headache, and extreme weakness. 48 hours later, most symptoms resolved but patient still c/o (L) shoulder swelling at site.
Information has been received from a physician concerning a female between 11 and 18 years old (exact age unspecified) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one several reports received from the same source. Additional information has been requested.
First negative tests were 19Apr & 20Apr; First negative tests were 19Apr & 20Apr; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis" (unspecified if ongoing), notes: Other medical history: Sinusitis; "known allergies kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "unknown" and all described as "First negative tests were 19Apr & 20Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Negative, notes: First negative tests were 19Apr & 20Apr; (20Apr2022) Negative, notes: First negative tests were 19Apr & 20Apr. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: About 5 days after finishing the treatment course of pills I felt like I was sick again. Headache back, Slightly dizzy at times, very congested, Tired, appetite off. I repeated a Covid Home test today and it is negative. First negative tests were 19Apr & 20Apr. Adverse event start on 23Apr2022,09:00 am, patient was recovering from AE, If treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
RN within our mass vaccination center drew Moderna vaccine from vial prior to the 15 minute room temperature recommendation.  The vial, Lot# 043L20A, was pulled from the refrigerator at 1:34pm CST.  The dose was drawn at approximately 1:45pm CST and was subsequently administered at approximately 1:47pm or 1:48pm CST.  This would have resulted in administration 2-3 minutes in advance of the 15 minute recommended wait time.   The timing error was discovered by this RN and another RN within the vaccination team approximately 2-3 minutes after the vaccination was administered.   We were unable to identify, with certainty, the patient within the mass vaccination center who received the dose.  We had no adverse reactions reported in the patient monitoring/observation area during the 15 minutes subsequent to our discovery of the early administration.  Our physician lead in the patient monitoring/observation was notified of the error.