chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AFIB ( had to get Pacemaker); Autoimmune type responses; Fever; Extreme joint pain; Difficulty walking without assistance; Chest pain; Weakness in legs; Onset of difficult to manage hypoglycemia with A1C 6.5; Diarrhea; Coordination issues; Fluctuating blood pressure and blood sugar; Fluctuating blood pressure and blood sugar; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 17:00 (at the age of 81-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, stent in heart, osteoarthritis, and COVID-19 (prior to vaccination). The patient received unspecified concomitant medications. The patient previously took REGLAN (metoclopramide hydrochloride) and experienced drug allergy. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient experienced short term fever, extreme joint pain, difficulty walking without assistance, and long-term autoimmune type responses, joint pain, AFIB (had to get pacemaker), and chest pain (chest pain) on 20Jan2021 08:00. The patient also had weakness in legs, onset of difficult to manage hypoglycemia with A1C 6.5, diarrhea, coordination issues, and fluctuating blood pressure and blood sugar on 20Jan2021 08:00. The patient was hospitalized all events for 2 days and hospitalization was prolonged (vaccine received during existing hospitalization). The patient receive pacemaker for AFIB and did not receive any treatment for other events. The outcome of the events was not recovered. Since vaccination, the patient had not been tested for COVID.  Information on lot/batch number has been requested.
Large localized reaction at the injection site approximately 15-20cm diameter occurring within 24 hr - successfully resolved treated with oral antihistamines.
Lump on clavicle that hurt; Arm hurt more; Pain at site of injection; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump on clavicle that hurt), PAIN (Arm hurt more), VACCINATION SITE PAIN (Pain at site of injection), HEADACHE (Headache) and FATIGUE (Fatigue) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Arm hurt more), VACCINATION SITE PAIN (Pain at site of injection), HEADACHE (Headache) and FATIGUE (Fatigue). On 03-Apr-2021, the patient experienced MASS (Lump on clavicle that hurt). On 02-Apr-2021, PAIN (Arm hurt more), VACCINATION SITE PAIN (Pain at site of injection), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, MASS (Lump on clavicle that hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  On 26-Jun-2021, the patient reported that he still have the lump, it still hurt and he just wanted it to heal and go away.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received on 26-Jun-2021 contain significant information: outcome of the event mass changed from unknown to not recovered.
Patient began feeling light headed within the 15 minute observation period post-vaccination. Of note, patient states he had not had anything to eat all day and only had some coffee. Paramedics onsite took vitals which were, BP 98/60, Pulse 50 bpm, O2 100%. Patient noted that he was an active runner, but stats were not typical. Paramedics noted that patient was ?very pale? and was still light headed 30 minutes after receiving the vaccine. After consultation with paramedics and patient, it was agreed to transport because of low vitals and no change in status. Patient was transported to local hospital and because of transport protocols, an IV of 90% NaCL was started.
Covid19 breakthrough.  1st vaccine received on 01/21/2021.  90 y/o female with PMHX of Factor V Leiden deficiency on anticoagulation, COPD, HTN, CHF, Afib presents to ED with c/o progressive weakness, cough and SOB.  Pt originally tested positive for Covid in Feb 2022.  Room air sat 97%, afebrile and CT chest multifocal PNA.  Pt started on IV ABX and Steroids.
pt recvd vax & exp flu-like sx p/1st & 2nd doses;
Two days post vax, this pt experienced a 'markedly swollen arm with cellulitis form shoulder to elbow. The pt was taken to an ER, admitted to the hospital and treated with IV antibiotics. The pt is now doing fine, and has recovered from his experience. The reporter indicated that an additional pt had a similar experience following exposure to hepatitis b vax recombinant (yeast). Additional information has been requested.
devel extreme dyspnea; was seen by local MD & given adrenalin; No other sx & no apparent local reaction @ site;
The day after I received my first dose (1/5/2021) I started developing the COVID cough, joint pains, tingling and loss of sensation in my feet, they were cold from loss of blood flow etc. (I had COVID in March 2020 and was sick from March to May.) After losing sensation in my feet, that is when I went to my PCP and they determined I getting loss of blood flow. They did blood work, that came back normal. They determined to use compression socks for my feet to get blood flow back etc. I was out of work for a day or 2 with a cough, and then went back.
lost all sense of taste and smell after the second shot; lost all sense of taste and smell after the second shot; 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), in 2021 as dose 2, 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 (first dose), for covid-19 immunization. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "lost all sense of taste and smell after the second shot".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Injection site redness & swelling of upper arm. Enlargement of arm lymph nodes.
In the middle of the night, I AWAKENED to the MOST SEVERE PAIN in my left arm. Thought perhaps a clot or a heart attack. ALTHO IVE NEVER HAD EITHER SO I DIDNT KNOW WHAT WHAT HAPPENING.  I just lay there in place. I was awake and alert so I figured neither of the above. However, when I tried to use my arm, in a number of directions,  It was extremely painful. I could not put this arm behind my back as tho to scratch my back. I am not sure if it was an attack on a MUSCLE or TENDON. I do know that in December 2019 I was given a 3-day dose of CIPRO anti-Biotics WHEN in the middle of the THIRD night I awakened with exactly the same reaction to the COvid vaccine BUT IN MY RIGHT LEG. In both instances it has taken me months to heal. I did go for therapy for my right leg event. Not for the left arm.  I can only conclude that there is a connection between the medications.
PT IS POST-CORNEAL TRANSPLANT IN LEFT EYE AND WAS DOING FINE, CLEAR VISION. ONE WEEK AFTER SHOT, PT REPORTS VISON BLURRED IN THAT EYE ONLY.
Redness and swelling of left thigh noted on 02/21/00. Was limping with left thigh pain yesterday. No fever. Noted to have 4x5 cm red, warm area on left anterior thigh. Joints with full range of motion. No other findings.
it is a cyst on his right knee; Right knee swelling got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CYST (non-serious), outcome "unknown", described as "it is a cyst on his right knee"; JOINT SWELLING (non-serious), outcome "unknown", described as "Right knee swelling got worse". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: He got the second one 26 Apr 2021. He is about to have MRI done with Contrast. It kind of dawned on him that it may be an issue getting contrast after getting the second dose and he wanted to make sure before he did it. He stated he has one done without contrast in between first and second dose and it was something that he had previously. He said it is a cyst on his right knee. He did notice that after second dose, the swelling did seem to get worse for a short period of time. This MRI was prescheduled in between the first and second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu-like symptoms (101-degree fever, headache, chills, lethargy)
per pt profile  12/21/22 moderna BIVALENT; SPIKEVAX GIVEN 10/31/2023; DO NOT HAVE PRIOR RECORDS TO BIVALENT
Woke up on 9/12 feeling extreme dizziness that lead to nausea and vomiting.  Also felt tired with alternating hot and cold (fever and chills).  Had all-over muscle soreness, shakiness, and weakness.  These symptoms lasted the entire day, with the shakiness lasting throughout the next day 9/13 as well.  Got some relief from OTC meclizine and Emetrol 9/12 mid-day for the extreme dizziness, nausea and vomiting.
Near syncope, lightheadedness, throat discomfort, chest pain, palpitations.
Called nurse line 4 days after 2nd Moderna vaccine, SOB, fainting, can't eat, dry cough, nose bleeds since shot. Advised to go to ED, patient refused as she feels a bit better today. Called again the following day with same symptoms - again advised to go to ED and quarantine for flu/covid-like symptoms. Patient agreed to come to ED, found to have bilateral PEs and RLE DVTs. Covid/flu negative. LUE red/swollen at injection site - no cellulitis. Admitted overnight and d/c'd home the following day.
Tested COVID Positive; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Tested COVID Positive) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.  Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (LOT number EP7534) on 01-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (LOT number ER8737) on 22-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (LOT number PE3592  (Booster)) on 30-Aug-2021 and PFIZER BIONTECH COVID-19 VACCINE (LOT number FJ4991 (Second Booster)) on 11-May-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included ATORVASTATIN and OMEPRAZOLE for an unknown indication.  On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Tested COVID Positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 14-Aug-2023 for COVID-19, at a dose of UNK, bid, 3 pills. On 19-Aug-2023, COVID-19 (Tested COVID Positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2023, SARS-CoV-2 test: Positive. On 19-Aug-2023, SARS-CoV-2 test: (Negative) No symptoms. On 26-Aug-2023, SARS-CoV-2 test: (Positive) Rebound covid. On 08-Sep-2023, SARS-CoV-2 test: Negative.   On 14-Aug-2023 Patient tested positive and on 19-Aug-2023 after 5 days, tested negative and on 26-Aug-2023 patient again tested positive (rebound COVID) and on 08-Sep-2023, tested negative after 13 days.
Fatigue, low grade fever, severe nausea (took zofran). Overall malaise. Slept most of the day 04/12 and took a 4 hour nap 04/13. Still exhausted, feel warm and extremely nauseated. No vomiting yet. Arm pain.
This is a non-serious spontaneous case, initially received from other healthcare professional (nurse) on 19-Oct-2018 and concerns a 38-year-old, adult, female patient. The patient had no relevant medical history and had not received any medication at the time of vaccination. On 09-Oct-2018, the patient was administered 1.5 ml dose instead of 0.5 ml FLUCELVAX QIVc (dose: 1.5 ml, batch number: 252235, expiry date: 20-Jun-2019, route of administration and anatomical location: not reported] (explicitly coded as overdose). On the next day after vaccination, the patient went home early because she wasn't feeling well, and she fell asleep because she was feeling tired and achy. On 11-Oct-2018, 2 days after vaccination, the patient's arm was super "extremely" inflamed, sore and she thinks she might have a different type of reaction. On 12-Oct-2018, 3 days after the vaccination, the patient ended up going to the urgent care because she had a rash. It was reported that, her arm was feverish and warm at that time. The doctor advised the patient to take BENADRYL and mentioned that there was no sign of infection, it was just a reaction on the vaccine. On 15-Oct-2018, the patient reported that, the arm was not bruised, not warm and she was no longer in pain, hence recovered from the events pain in extremity, pain and warm skin. The outcome of the event (inflammation, malaise, rash and fatigue) was not reported.
Patient received both vaccines in the same arm due to pt. request. He said that the next day he went to the E.R because his arm starting to turn red and swell up. He left the hospital today (08/14/17) and was prescribed prednisone, BENADRYL, and PEPCID.
onset of extreme listlessness, would arouse enough to feed only, but would fall asleep; this lasted for 2 days; no fever;
It was reported that a 28 year old female pt received a Fluzone SV '99-'00 vaccination on 11/24/99. Reportedly, on 12/8/99, the pt developed blurred distant vision. An optometrist examined the pt and there was a slight symmetrical difference in vision per exam. The optometrist recommended evaluation for medical problems.
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult pregnant female patient who was vaccinated with TENIVAC (lot number and Expiry date unknown) via unknown route in unknown administration site instead of ADACEL. The date of last menstrual period, estimated due date and gestation period was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due wrong vaccine administered. (It was reported that pregnant female that had been given a TENIVAC instead of ADACEL). It was also a case of vaccine exposure during pregnancy. It was unknown whether adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (dose: 0.5 ml, lot # K009902, expiration date 06-MAR-2017, route and a vaccination series were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
throat tightness; wheezy; throat itching; frequent throat clearing; This is a spontaneous report from a non-contactable other healthcare professional. A 38-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9266) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy, allergies including anaphylaxis to shellfish, peanut oil and sulfa drugs , food allergy, drug hypersensitivity and asthma. Concomitant medication included montelukast sodium (SINGULAIR), cetirizine, salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]). It was reported that she did not take any Benadryl prior to her injection as patient reported that her sister who was a nurse told her not to take Benadryl in case it masks a reaction. Patient complained of frequent throat clearing (slightly upon arrival. With throat itching) and wheezing. Patient denied chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath. During her 30 min waiting period after the injection the patient experienced throat tightness, wheezy. She reported above symptoms about 20 minutes after receiving vaccine. She denied facial swelling, tongue swelling. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Dizzy; cranky and irritable; This is a spontaneous report from a contactable consumer (parent). A 38-year-old male patient received first dose of bnt162b2 (Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on an unspecified date as single dose for COVID-19 immunisation. Medical history included diabetes, depression (mental illness), smoker, alcohol, from an unknown date, unknown if alcohol is ongoing. Concomitant medication(s) included metformin taken for diabetes mellitus, start and stop date were not reported. The patient is going to be 39 in two week and he is not normal boy at all and the fact that he wanted the reporter to take him to go get the shot last time and shot this time just blew the reporter away because usually he is like leave me alone. I will do it myself type stuff. He has mild limited health issues but last time they went they didn't stay after the shot. He got dizzy real dizzy, dizzy in the sense the reporter almost took him to the hospital and they had probably been a block or 2 of it, and he said now I am really fine. The another problem to know about that ,he was cranky and irritable after the first shot . He also a smoker, alcohol, the reporter was comfortable with his drinking the reporter doesn't know if he is doing that anymore. But he is smoker and he is a diabetic. He is on Metformin. About the lab test, reporter stated, "Not that I am aware of. May be a couple of weeks ago he had some blood work done for HIV but I am not sure." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it was nerves. No one asked how I felt after the vaccine and was passed along ( I told my daughter - who drove me - about my neck while at the vaccine site.) I noticed that my face was also going numb a few minutes later. As soon as we arrived at our meeting place, I told my daughter that my face(vaccine side) was also numb: "like when you get an injection for dental work." It is now ten hours after I received the vaccine, and the numbness has not seized. It is still there and with a strong tingle sensation. I also feel generally unwell with body aches and weakness.
Beginning 20 days post 2nd vaccine dose: fever, chills, headache, low grade fever, sore throat, throat slightly swollen, shooting pain in left breast (around implant) with hot and red skin. Continuing for 3 days as of reporting today.  Immediately Post 2nd vaccine dose: low grade fever; chills; fatigue; low appetite; pain in leg, groin, and back lymph nodes lasting less than 48 hours.
Patient received 2nd Pfizer COVID vaccine on 5/21/21. He had fever and headache for about 24-36 hours, which he had also had after the first dose of the vaccine. On 5/23, he woke up with constant substernal chest pain, which worsened with exertion and deep inspiration. The pain increased throughout the day. In the ED, he was found to have elevated troponin ,CK-MB,  elevated CPK, and elevated liver enzymes. EKG was concerning for ST elevation initially.  Bedside echocardiogram showed low-normal function, normal coronaries, trace effusion, and no evidence of RV strain. Troponin and NT pro BNP were increased upon admission to our facility. Repeat ECHO showed borderline global hypokinesis of the LV with an LVEF of 51%. He received IVIG on 5/24/21 and also was started on ketorolac on 5/24/21. Troponin and CK were trending downwards at the time of this submission.
Within 30mins: lightheaded, muscle fever, tight throat, headache, shallow breathing, brain fog, irregular heartbeat, BP increase, dizziness, flushing, thick sinus drainage that was choking, electrical pulse under my skin, joint inflammation. Lasted 3 days  Starting a week after vax and lasting 8 weeks: pain in chest....like a constricting circle around heart, irregular heartbeat including episodes of tachycardia daily, shortness of breath often,  inflammation in joints and muscles, brain fog, female cycle/hormone changes that were pretty drastic (spotting every other day, hormone changes including depression with every cycle adjustment), fatigue, listlessness, insomnia. impacted sinuses, constant electrical impulses under skin (jitters).
patient was instructed to sit in the vaccine administration area at 10:55 am for observation for 15 minutes; At 11:05 am patient approached one of the two pharmacists to alert them that she was experiencing warm arm and itchy hand; patient also informed pharmacists that she injects herself with peptide shots containing anti-histamine occasionally and she gave herself a peptide shot on 4/14/21, the day before she received the moderna covid 19 vaccine.  She said that she usually take claritin 10 mg; patient's husband went to purchase claritin and patient was instructed to sit and wait for the claritin.  claritin 10 mg was taken  at 11:15 am; patient was stable and the itch went away at 11:50 am and patient left with an ice pack on the arm.  pharmacist made a follow up call at 1:30 pm and patient called back and reported stable and no symptoms.