chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient tested positive for COVID; patient tested positive for COVID; Had the 1st dose of COVID 19 vaccine last 26Dec20 - Due for 2nd dose on 27Jan21; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID and quarantined on an unspecified date. The patient had the 1st dose of COVID 19 vaccine last 26Dec2020, will be due for 2nd dose on 27Jan2021. The patient asked if it is safe to have the 2nd dose of the vaccine. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date. The outcome of events was unknown.    Information about lot/batch has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
my second ( NOT THE FIRST ONE! ) vaccine received 0700hrs. 1/26/2021 ( my 2nd one )  By 2pm, extreme exhaustion, tiredness, mild achiness all over, persistent mild headache. By that evening, fever ( not checked nor confirmed but probable) 14 hours after the vaccine with rigors. Body aches for 24 + hours after receiving vaccine. plus intermittent headache.   By 36 hours later, still having intermittent fever (100.1 ) with body aches and sheer exhaustion.  I am a nurse in an I.C.U.  I had to call off work today, 48 hours after the vaccine. was received. Mainly for this persistent exhaustion. Also this damn headache still hanging around...mild but irritating. I know none of this is what I would call ADVERSE but my co-workers insist I need to fill out this information so I am. I it 50 hours from the vaccine and I am tired, slow and have to lay down and rest. It's stupid. My first vaccine was NOTHING . I have not had covid and I don't plan on it.  :)
REDNESS TO LEFT ARM, WARM TO TOUCH. PATIENT STATES REDNESS OCCURRED A COUPLE OF MINUTES AFTER RECEIVING VACCINES AND ARES IS HARD AND WARM. PATIENT ADVISED TO PUT COLD COMPRESSES AND COME IN FOR FOLLOW-UP ON 6/25/11. NOTE: ALSO HAD A TUBERSOL-PPD SHOT IN LEFT ARM.
patient was given Fluzone Quadrivalent instead of Fluzone High dose Quadrivalent, no AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a male patient (age above 65 years old) who was vaccinated with a once dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on 28-Sep-2020 for prophylactic vaccination (batch number and other dosing details were not reported).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was an actual medication error case due to wrong vaccine administered (latency was same day).  The reporter wanted to know that how long they need to wait before administering the FLUZONE HIGH-DOSE QUADRIVALENT and if there are any adverse events to be aware of.  No adverse event reported to the patient at the time of reporting.  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.  There will be no information available on the batch number for this case.
This spontaneous report as received from a registered nurse refers to a 5 year old patient of unknown gender. On 18-AUG-2014 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (lot# K002930, expiration date 26-FEB-2016, 0.5 ml, subcutaneous), which had been improperly stored at -12.2 for 3 hours cumulatively. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
got really sick; felt like passing out; got dizzy; nauseated feeling; blood pressure went down or up; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient called to inquire about what time she would be picked up for her second vaccination and reported that after her first dose she ate a pork chop and got really sick; further stating she felt like passing out and got dizzy. She reported that two weeks after she still had a nauseated feeling like she was going to throw up and was unsure if her blood pressure went down or up because she couldn't find her blood pressure cuff. She inquired if the second dose of the vaccine would be worse. The clinical outcomes of got really sick, felt like passing out, got dizzy, nauseated feeing and blood pressure went down or up were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
04/04/2022 after my vaccine, I don't believe I had a fever, I did not feel well and slept for a couple of days. I was very achy and I don't recall much else. I did take some acetaminophen for the achiness. After a few days of rest I did start to feel better afterwards.
After being vaccinated my heartrate went up to 140 beats per minute while sitting down. I also had a 103 fever, chills, and body aches for about a 24-hour period. My heartrate continued after that though. I went to the Emergency Room, and they ran blood work, and my troponin levels were elevated so the m kept me for a few days. They ran a Stress Test, Echocardiogram, and a Cardiac MRI, which showed and enlarged heart and a bundle branch block. I was diagnosed with Global Hypokinesia and Myocarditis. I was released and told to follow up with a Cardiologist. Everything is staying the same for now, I was prescribed Entresto and a Metoprolol to reduce my heartrate.
Patient presented to urgent care with 3 days of pleuritic chest pain.  He had abnormal EKG with T wave inversions in V1 to V3, elevated D-dimer and elevated troponin. Sent to ED.  Patient received Pfizer Covid vaccine, first dose, approximately 2 weeks ago.  About 3 days ago he developed chest pain with breathing, located at the anterior chest and radiating to the left shoulder.  No associated cough, dyspnea, sputum production, hemoptysis.  Chest pain is not associated with activity.  He does not describe chest pain with the positional change or laying down. no fever or chills.  He had 3 episodes of emesis this morning.  No abdominal pain, no diarrhea.
Regional lymphadenopathy, left supraclavicular adenopathy on lateral side of vaccination.
soreness at the injection site; Headache; Felt like going to faint; Dry heaves; Passed out; Nauseous; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 74-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included fainting (fainted on airplanes and at dentist) and low blood pressure. Previously administered products included Flu vaccine with an associated reaction of vertigo (15 years ago, experienced Vertigo). Concomitant products included COVID-19 VACCINE (COVID VACCINE).   On 02-OCT-2023, the patient received RSV vaccine (left arm). On 02-OCT-2023, immediately after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: soreness at the injection site) and headache (Verbatim: Headache). In OCT-2023, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant), nausea (Verbatim: Nauseous), felt faint (Verbatim: Felt like going to faint) and dry heaves (Verbatim: Dry heaves).  The outcome of the passed out, injection site pain, headache, felt faint and dry heaves were resolved and the outcome of the nausea was resolved (duration 2 days).   It was unknown if the reporter considered the passed out, injection site pain, headache, nausea, felt faint and dry heaves to be related to RSV vaccine.     It was unknown if the company considered the passed out, injection site pain, headache, nausea, felt faint and dry heaves to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-OCT-2023 The reporter was a patient. The reporter reported that she received RSV GSK vaccine vaccine in the early afternoon of vaccination day. Shortly after vaccination the patient felt soreness at the injection site, and a headache. Around midnight of vaccination day, patient felt nauseous, and got up to use the bathroom, the patient felt like she was going to faint, and then laid herself down on the bathroom floor, the patient passed out, and  when she came to, went back to bed and experienced dry heaves. The patient experienced nausea for 2 days. The patient experienced vertigo from a FLU vaccine (undisclosed manufacturer) 15 years ago. The reporter received a COVID vaccine (Pfizer) in the right arm 2 weeks prior to receiving the AREXVY vaccine. The reporter did not state that she received AREXY by name, but stated it was the GSK RSV vaccine. The patient had fainted on airplanes and while at the dentist the patient describes the fainting as fainting from low blood pressure. The patient did not take her blood pressure during reporting time. The reporter consented to follow up.
Patient came in for her covid pfizer vaccine booster.  Staff called pharmacy asking for an unopened covid pfizer vaccine vial since the only one we had had been punctured on 3/14/22 at 1400 and today is 3/16/22 @ 0730. Opened vial had been refrigerated since 3/14/22.Pharmacy attendant misunderstood what exp date we were talking about and said we need to go with the thaw expiration date. Therefore, patient was given a dose of the  covid pfizer vaccine which actually expired @ 2000 on 3/14/22. Patient did not have any adverse reaction to the injection. I called patient at 1500 on 3/16/22 and shared what happened and told her that a repeated dose was recommended at the timing of her choice. She states she will come back on 3/22/22 @ 0810 to receive her repeated booster vaccine.
1/13/22 She has been alittle more tired, c/o intermittent sore throat, headache. She has not had fever. She is cont to eat well and sx are mild. Mild nasal congestion as well. Dad has sore throat and ear pain. Other household members are healthy, and vaccinated if of age. 3yo sibling is unvaccinated but already home for school exposure quarantine. Constitutional:      General: She is not in acute distress.    Appearance: She is well-developed.  HENT:     Head: Normocephalic.     Right Ear: External ear normal. There is no impacted cerumen.     Left Ear: External ear normal. There is no impacted cerumen.  Eyes:     General:        Right eye: No discharge.        Left eye: No discharge. 1/13/22 Neck:     Thyroid: No thyromegaly.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds. No murmur heard. Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds.  Musculoskeletal:     Cervical back: Neck supple.  Lymphadenopathy:     Cervical: No cervical adenopathy.  Skin:    General: Skin is warm.     Findings: No rash.  Psychiatric:        Behavior: Behavior normal.
Mom reports that 4/7/16 that client had (L) arm itching, swelling and discoloration or redness to skin. Client skin just appears darker in area where received shots. She called ER and was told give MOTRIN, BENADRYL and she gave it over the weekend. Today slight darker in color no noticeable edema noted.
Case number PHEH2014US018282 is an initial spontaneous report received from a Medical Assistant on 11 Sep 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. On an unknown date, the patient was intramuscularly vaccinated with MENVEO (batch number: not reported) which was stored between 30 to 35 degree Fahrenheit for about one and a half day. No adverse event was reported following this medication error.
TPA aborted Stroke on day 5 post vaccine. Probably not related but was told I needed to report it.
A few minutes after administration, pt. had a near syncopal episode and vomited. She then went on to have a severe headache and vomiting which resolved 8-10 hrs. after vaccine.
Sore arm and fatigue the first and second day. I was supposed to have gone to get my second injection on May 13, 2021 but have not gone since learning of my shingles outbreak on May 6,2021. Awaiting counsel on when I should attempt the second dose
2 days post MMR vax 4MAY93 pt devel course of ascending sensory & motor neuropathy, including mild transient involvement of resp musculature;clinical picture included some features of upper motor neuron sx hyperreflexia;prob encephalopathy;
I started having pain in my ankles that have increased to a continually flashing pain. I had dry eyes, low-grade fever. I went to my doctor who referred me to rheumatologist. She ran blood tests and did x-rays that came back showing that I have factors for rheumatoid arthritis. I will be calling the doctor back to today to confirm the diagnosis and determine if I will be put on medication to combat the pain.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients. On unspecified dates, the unspecified number of patients might have been administered up to 0.6mL of GARDASIL, (lot#, expiry date, route and indication not reported). No adverse effects reported. No patient contact details provided. The nurse stated that a single dose vial of GARDASIL contained approximately 0.6 ml, sometimes more. And the nurse asked "Is the whole amount that is drawn up, given? or should only 0.5 ml be given?". Additional information is not expected.
Prevnar administered on 5/7/01 in left thigh. Injection site with small knot and slight redness of skin over site.
lt thigh sterile abscess; 2cmx7cm w/surrounding hematoma;
Cold sore inside part of lip,  single angiodema type rash/hive on outside part of lip directly opposite cold sore, elevated resting heart rate at 95-105 (normal 71-80
2019 Novel Coronavirus RNA detected 11/17/1021 Hospitalized 11/17/2021 Patient died
Patient received 2nd dose of Pfizer vaccine at around 1905. Started to have clammy, shortness of breath,  and chest tightness. Progressively got worse. Vitals taken and were stable. BP 150/70. Oxygen 94% and HR 74. Epinephrine not given further evaluation done in the ER at 1930.   Additional information: Unexpected. Patient was screened for potential side effects from previous dose prior and had no other allergies to our knowledge.
This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced hypoesthesia (right arm started to get tingly/arm tingled down to fingers and went numb) and paresthesia, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101238322 same reporter/drug/AE, different patient.
Client started feeling flushed, dizzy, nauseous, hands were numb  and he looked pale. Drink was given, he was monitored and the felt better a few minutes later.
Patient says shot was given to high and the patient  is experiencing severe arm pain/soreness to the point where he can't sleep. Patient is unsure if its from where the shot was given or if its due to the vaccine its self. He just states that the pain is so severe and does not feel like its normal.  Patient will contact his provider to get checked out.
Important to share: I had a strong case of Covid in March, 2020. No hospitalization and no need to go to hospital but I was very sick for three weeks. Oddly, after Covid I had odd heart pains and erratic high blood pressure. I saw a cardiologist and my heart was fine but it lasted on and off for months. I've been very well for months now.   1) The day after the shot, I felt tired and had a headache, which is expected and no big deal. The evening after the shot I experienced a lot of pain around my heart area. It was very similar to what I experienced post-Covid but more painful. It hurt enough that I went to the ER at Hospital in because of the chest pain. EKG, chest x-ray, and all blood tests were normal.   2) The next day, I fell asleep on a hammock in my backyard. I was wearing jeans and a sweater so the sun wasn't directly on me but I noticed later that the outside of my R leg and the inside of my L leg were covered in a red, lacey-looking rash. Oddly, my arms and torso had no rash. I called my Internist (Dr.) who asked me to email photos. She said it looked like an allergic reaction to the vaccine and advised me to submit info on this site and to take a benedryl. The rash was definitely where the warm sun hit me.
pt received COVID vaccine at the local pharmacy on 11/10/21 in left arm.  Patient started with lymphadenopathy on 11/11/21.  Patient was seen in our clinic for evaluation of lymphadenopathy on 11/12/21 (medium sized left axillary node as well as small supraclavicular lymph node).   Requires follow up appointment in office in 1 week for recheck
A little over 30 minutes post first dose, had a racing heart and mouth started to swell.   No immediate reaction/issue after the second dose.   About a week later, experienced left side of face going numb, difficulty swallowing again, and production of saliva.   Face numbness become severely numb; is episodic and period of numbness varies on activities and/or stress level.  Difficulty swallowing is moderate in nature; impacts the types of foods she is able to eat and the length of time it takes to consume.  Impact with more than usual weight loss.  Lost 60 lbs in 4 months.   Saliva production is moderate, thick, and constant; impacts sleep and ability to do dental work.  Chokes during sleep occasionally.
Became very tired the evening of 11/8. Slept for 10 hours. Woke up with soreness in back and at injection site. By 8am on 11/9, onset of fever, chills, and exhaustion. Smell and taste became distorted that same day.  Little improvement in smell or taste over the next  6 months. Started seeing an ENT in the beginning of May, 2022.  Started a cortisone nasal treatment to help heal the inflammation issues in my nose from vaccine. Expected that process will take months to heal correctly, possible even more than a year.
M reports that he developed tachycardia the evening of receiving his 2nd hepatitis B vaccination. Received the vaccine at 1300 that day. States since that evening he has had multiple tachycardic episodes when he feels palpitations and at times experiences dizziness. The following day after the vaccination his episodes worsened and he went to the ER. He has been seen by cardiology who diagnosed SVT. He is still having multiple episodes/day. Denies any other systemic symptoms. He states he will be scheduled for an ablation in the near future. Has been started on long acting beta blocker which he states have lessened the intensity of episodes. Squatting triggers episodes or they can occur with no triggers. Sitting down or valsalva maneuver will lessen / abort symptoms. He questions whether or not his new cardiac condition is related to receipt of this Hep B vaccine. The vaccine package insert states that rare instances of tachycardia and syncope have been reported after receiving this vaccine.
Really bad headache, nausea, dizziness, fever, achy all over, arm swollen even in arm pit and really sore,diarrhea
This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was reported. On 06-JUL-2016, the patient was inadvertently vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # L042258, expiration date 18-AUG-2018, dose and route of administration were not provided). No adverse were effects reported. Additional information is not expected as the reporter did not wish to be contacted.
Severe left upper quadrant pain that lasted 5-6 hrs. Next day Lipase level checked and was 1,749 (max norm 396). Next day increased fatigue, some chills and moderate headache. Wednesday, headache continued which was severe, worsened chills, continued fatigue and mild nausea. All labs returned to normal by Wednesday and no evidence of pancreatic inflammation/damage or gallbladder disease on CT or ultrasound.
Tenderness to R deltoid, headache.  Bilateral tenderness of medial thighs.
It was sore for a couple days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. Patient just received dose and experienced sore for a couple days. The patient did not want Shingles. Patient reported that her husband had Shingles vaccine after his heart attack and it was not good.
High fever up to 103, fainted, dizziness, respiratory problem, muscles and joints hurting, eyes burning,thirsty  and injected arm was  hurting.
bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO Concomitant & Treatment drug reported.
A red, raised welt appeared on my are on 9/30/2022 that was warm to the touch. Arm was very sore. On 10/1/2022, the welt increased in size (about the size of a large orange) and started to itch slightly. I took ibuprofen at night and benadryl. The redness has subsided on 10/3/2022, but the welt is still there.
Pt recd vax & exp aching all over, diarrhea, h/a (temporal pain), upset stomach, low grade fever, & palpitations when moving from sitting to standing position & vice versa; pt allergic to Hep B vax;