chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Saturday November 6:  Swollen facial, inflammation lips, dry throat, feeling of suffocation, shortness of breath. Sunday November 7: fever, head pain, dizziness, sleepy, inflammation left arm. Monday November 8: fatigue, chills, momentary hearing loss, head pain, sleepy. Tuesday November 9: fatigue, chills, head pain, dizziness, momentary hearing loss. Wednesday 10: chills and head pain, dizziness. Thursday 11: inflammation lips, dry throat, feeling of suffocation, shortness of breath, chills. Treatment: Pharmacist instructed me to take acetaminophen for head pain and fever. For the other symptoms of Thursday 11 I took BENADRYL in capsule of 25mg.
chill; sweats; This is a spontaneous report from a non-contactable healthcare professional. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient had no medical history. It was unknown if patient had COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. The patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks of COVID-19 vaccine. The patient previously took Bioxin and experienced drug allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported) (at the age of 34-years-old), intramuscular, administered in left arm on an unspecified date for COVID-19 immunisation and experienced severe headaches intermittent for over a week, "cloudy" head, sweats/chills, severe sudden onset exhaustion, difficulty maintaining thoughts or focus. The patient experienced chills and sweats on an unspecified date (1 day). The patient received no treatment for the events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
"The patient presented with symptoms of pericarditis and palpitations.  Evaluation revealed elevated troponin levels consistent with myocardial injury, ST elevation on ECG (consistent with pericardial inflammation) and short episodes of non-sustained ventricular tachycardia that were not hemodynamically significant.  Echocardiography revealed normal anatomy and normal ventricular / valvular function with no pericardial effusion.  He was observed in hospital on telemetry for 24 hours and transitioned to outpatient care with exercise restrictions as well as oral non-steroidal anti-inflammatory and colchicine therapy.  Clinical diagnosis was peri-/myocarditis without ventricular dysfunction."
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 15-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 08-MAY-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #U039722 (lot# reported also as U0397722), expiration date: 15-DEC-2023, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Pt recv vax on 10/9/98; on 10/22/98 pt exp rash on stomach, back &face w/ tiny red, raised bumps.
Swollen, painful lymph node in left armpit that resolved after 2 weeks with no treatment. Swollen, painful lymph node under chin that resolved after 4 days with no treatment. Examined by an MD and advised to monitor for worsening symptoms.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 02-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # N010497 for prophylaxis. On 02-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
Had had hives ever since receiving H1N1 injection on 11/4/09. No swelling or resp distress. Resolves with Benadryl; but recurs when it wears off.
Less than 0.5ml of 2nd dose administered; Syringe connection issue; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Less than 0.5ml of 2nd dose administered) and DEVICE CONNECTION ISSUE (Syringe connection issue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction (No reported medical history).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3. On 25-Mar-2021, the patient experienced UNDERDOSE (Less than 0.5ml of 2nd dose administered) and DEVICE CONNECTION ISSUE (Syringe connection issue). On 25-Mar-2021, UNDERDOSE (Less than 0.5ml of 2nd dose administered) and DEVICE CONNECTION ISSUE (Syringe connection issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. This report refers to a case of Underdose and Device connection issue, for mRNA-1273, lot # unknown,  with no associated AEs.; Sender's Comments: This report refers to a case of Underdose and Device connection issue, for mRNA-1273, lot # unknown,  with no associated AEs.
I had another unexpected period, a lot of cramping, and infertility. I had an extreme amount of bleeding for 15 days of my cycle, which has never happened before. I had high blood pressure and a fever up to 15 days after the vaccination. (Please note, my husband and I have been practicing Marquette method of Natural Family Planning (NFP) since 2/21/2020. At the time of my second dose of the COVID-19 injection, I have charted 23 cycles. During this cycle, it began on 10/22/21, I did not have a rise in estrogen nor LH. This is entirely abnormal prior to the injections and has never happened before in my life. Then, I only had a 24 day cycle, which my average is between 30 to 32 days exactly.)
Moderna Dose 1 3/5/21 (NA) Moderna Dose 2 4/9/21 (NA) COVID Positive 2/18/22  2/17/22: Patient is 84-year-old female coming from home with past medical history of chronic hypoxia on 3 L oxygen at home, atrial fibrillation anticoagulated with Eliquis, moderate aortic stenosis awaiting for TAVR, HFpEF, essential hypertension, pulmonary hypertension and gout. She was brought to the emergency room by family members for complaint of generalized weakness, decreased appetite, nausea and altered mental status.  Earlier this evening, patient was noted by her children not feeling herself.  Per family members, she was noted to be confused.  She was noted to be sliding down on her chair neck.  Patient reported she has been having poor appetite with belly pain for the past 2 days.  No report of nausea or vomiting. Patient reported dry cough.  No report of chest pain fever chills or rigors.  Patient is fully vaccinated for COVID-19.  No recent sick contacts.  Patient reported she has been having progressively worsening exertional dyspnea for the past 7-8 months.  She has moderate/severe aortic stenosis.  She is scheduled to have TAVR.  Patient denied use of tobacco products or alcohol products.  Upon evaluation at the emergency room, she was afebrile and hemodynamically stable.  She was maintaining 3 L of oxygen to maintain saturation which is her baseline.  Labs were significant for mild transaminitis, creatinine of 1.07 which is close to her baseline, proBNP of 2993, and macrocytic anemia with hemoglobin of 11.6 gram/deciliter. Nasopharyngeal swab was positive for COVID-19.  Chest x-ray revealed bilateral infiltrates.  Urinalysis revealed small leukocyte esterase.  Patient was recently treated for UTI. At the emergency room, patient received Lasix 40 mg IV and ceftriaxone 1 g IV.  3/6/22: -Continue with the current management.  -appreciate pulmonology recommendations.  -steroid taper per pulmonology  -Continue Precedex, will continue to wean the Precedex. Patient previously did poorly with Ativan and Haldol. Xanax through the NG tube p.r.n..  - monitor and replace electrolytes as indicated.  -appreciate pulmonology initiating thrombocytopenia workup.  -possible intubation later on 03/06/2022.  -Code status:  Full code   DVT ppx:  Patient was started on heparin drip on 03/05/2022 due to elevated D-dimer.   Disposition: Patient was made DNR by the family.  Patient expired on 03/06/2022 evening.
long term COVID; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (long term COVID) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (long term COVID). At the time of the report, POST-ACUTE COVID-19 SYNDROME (long term COVID) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  Formulation of Humira (Adalimumab) was reported as Solution for injection in pre-filled pen.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided by the reporter.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of long COVID and drug effect decreased were not provided (not reported).  Company Comment:  This spontaneous case concerns a male patient of an unknown age, on treatment with biologics Adalimumab for concurrent Ankylosing spondylitis, who experienced the unexpected non-serious event of Post-acute COVID-19 syndrome (long term COVID) that occurred on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine. Outcome was reported as not resolved.  No information was provided on any other doses of COVID-19 vaccination. Treatment with biologics Adalimumab (for concurrent Ankylosing spondylitis), an immunosuppressant, increases the risk for infection, thus, remains a confounder for the event for concurrent Ankylosing spondylitis The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a male patient of an unknown age, on treatment with biologics Adalimumab for concurrent Ankylosing spondylitis, who experienced the unexpected non-serious event of Post-acute COVID-19 syndrome (long term COVID) that occurred on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine. Outcome was reported as not resolved.  No information was provided on any other doses of COVID-19 vaccination. Treatment with biologics Adalimumab (for concurrent Ankylosing spondylitis), an immunosuppressant, increases the risk for infection, thus, remains a confounder for the event for concurrent Ankylosing spondylitis The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Four hours after shot, I went into afib while resting.  I have never had this condition prior.
Received shot at 10:00am on 5/5/2021. On 5/6/2021 Patient began to feel ill with fever, chills and body aches.  Spent most of that day in bed.   On 5/7/2021 presents to Clinic, fevers, chills and body aches had improved but noticed "rash" - right lower extremity was red, hot to touch, swollen, pain with "tightness" and "burning" sensation at site.  Denies itching.  Right Lower Extremity well demarcated area of erythema, hot to touch and remarkably TTP, particularly  at anterior surface of leg. Erythema extends on anterior surface of leg from ankle up to 8cm inferior to the knee cap ;the erythema on the posterior surface of the leg extends from ankle up to about half way up the calf. Erythema is confluent. Anteromedial surface of the skin has diffuse petechiae. Negative Homan's sign and no calf tenderness, 2+ pitting edema from ankle to midway up the shin.
pt recvd vax 10JUL95 & 12JUL95 pt devel a localized rash & a fever of 99.2;no further details were provided;
Swollen supraclavicular lymph node on same side as injection; This is a spontaneous report received from a contactable consumer. This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration on 22Mar2021 at 17:45 (at the age of 41-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included POTS and Hashimoto's. The patient has known allergies. Patient was not pregnant at the time of vaccination.  Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot Number: EN6202) on 01Mar2021 at 05:45 PM in left arm. The patient did not receive any other vaccines within four weeks prior to the 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. On 26Mar2021, the patient experienced swollen supraclavicular lymph node on same side as injection. There was no treatment received for the event. The outcome of the event was not recovered.  Follow up information requested.
Unilateral facial and upper lip swelling on left side of the face started approximately 24 hours after vaccine dose 2. Benadryl 50mg taken before bed and swelling remained in the morning of 1/28. Benadryl 50mg and 20mg Pepcid taken the morning of 1/28 and ice applied to the area of swelling. No facial dropping (smile is symmetrical), no swelling of tongue/throat, no difficulty breathing.
Patient became pale, had chest pains, difficulty breathing, vomited, red spot formed on tip of tongue. 911 Was called. Patient was helped to the floor and a he was no longer vomiting. He was feeling better with chest pains relieved and no difficulty breathing. The red spot remained on his tongue and he was very pale. Paramedics came and he went to the hospital.
Bells Palsey, currently impacted, recovering,  prednisone, valacyclovir
After 1st vaccination, I had immediate tingling and numbness to my left arm which extended to my left hand. After day 2  had a panic attack which I have only had 1x in my life prior to this event, had fatigue and difficulty getting out of bed, had heavy arms. Had changes in my pulse to include rate dropping to 40's and racing heart at times. Called physician nurse's line to ask if I should receive second dose.  I did not receive a callback, so went for second dose. After 2nd dose on 1/25/2021 (Lot# EK9231) I began to have brain fog and malaise, was having mild insomnia at this point and went to my PCP on est 2/24. She ran bloodwork including CBC, vitamin levels. Everything was WNL.  I then f/u est 3/2/2021 for tingling and numbness to my left side  including LLE,LUE and face. CT scan was done and hormone levels. All WNL. Given Gabapentin 300mg BID which did not resolve issue and sent to Neuro. MRI of head and neck done which were WNL, my pulse stayed elevated and I was sent for an EKG from neuro. Within a week of this appointment I began experiencing joint pain on my left side only to knees, elbow, shoulder, ankle,hip. Autoimmune labs were done and all WNL.  I could not tolerate caffeine or alcohol to any degree without shaking, prior to this had several coffees a day. Within a week of this appointment, my insomnia worsened and I could not sleep and began having panic attacks at night and having issues with my body shaking during the day. Seen my PCP several times through March. I could not sleep with OTC medications, could not sleep with prescriptions pills that my PCP prescribed to include Trazadone, Klonopin, Lunesta, Ambien or Doxepin. Not only could I not sleep at night. I could not nap during the day or fall asleep. Ended up in the ER after BP of 220/140. After, I was referred to Cardiology and Sleep specialist. Sleep study was done which stated I slept 4 hours and woke 8x an hour with melatonin, Magnesium and Lunesta 3mg. Cardiologist ran a CTA and EKG, both WNL. My pulse was/is raising in the mornings to 120-160 and a 72 hour holter monitor was done and awaiting results currently. An echo is scheduled for 6/25/2021. Followed up with neuro d/t new onset of hemifacial spasm to Left side of face. When I raise my mouth to smile, my face twitches and the left side droops. Have an appointment with endocrinologist on 6/21/2021. I also ended up sick with strep throat 2x and had never had an incidence of strep in PMH. I took FMLA from work d/t inability to sleep and function to include still currently tingling to left side, hemifacial spasm, brain fog, increase in anxiety.  Most symptoms were left sided only that I have experienced. Site of both vaccinations was left arm. I have  had 24+ encounters  with PCP/hospital and specialists since February d/t these issues. My prior hx was having gone 2-3x a year.
Patient experienced a minor seizure-like reaction that lasted for about 5 seconds. Patient was monitored for about 30 minutes. Blood pressure, heart rate and oxygen saturation were normal.
Sudden hearing loss in one ear; This is a spontaneous report from a contactable consumer (patient's wife). A 64-year-old male patient received bnt162b2 (Pfizer product), dose 1 via an unspecified route of administration, administered in arm on 18Apr2021 18:15 (Batch/Lot number was not reported) as single, dose 2 via an unspecified route of administration, administered in arm on 09May2021 18:15 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient experienced sudden hearing loss in one ear on 27Apr2021 16:30. Therapeutic measures were taken as a result of sudden hearing loss in one ear (sudden hearing loss) include prednisone on 27Apr2021 then again on 23May2021. He was treated by a doctor who sent him to another doctor that put him on steroids and he started getting better. He got his second dose and two weeks later the same thing happen, sudden hearing loss, he can't hear in his ear. Clarifies the sudden hearing loss is in one ear. The last outcome was unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
Substantial pain in jaw on my right side. Pain radiates to ear. Hurts to open my mouth and chew. My jaw was clicking yesterday. Pain is way worse today Vs yesterday.  I?ve never had this hurt so bad.
Moderate arm pain, shivering, marked fatigue, joint pain, lack of appetite. Shivering occurred 12 hrs after injection. Marked fatigue and joint pain within 24 hrs of injection.
I had the usual aches pains and headache. I got a rash on my left arm over there entire area and it swelled up. The doctor just told me to take Benadryl
Patient says she developed shortness of breath, leg edema, progressive chest congestion  with productive cough.   Progressively worse until was admitted to the hospital on March 28,2021 with 'heart inflammation" , developed arrhythmia and subsequently diagnosed w congestive heart failure.
pt recv vax 1OCT97 & on 2OCT97 pt c/o heaviness of arm;also said that arm was swollen, hot to touch, red & sore @ the site of inj;pt seen by MD who treated w/med;pt recovered;
1/24/06 - polio shot at 2:40 pm at Health Department.  4:00pm acting very sleepy, temp started rising up to 104.7, just stared into space, not moving much or making noise. Called Dr at 9pm he said to give acedamediphin and it could last 72 hours.  Treated with acedamediphin and temp dropped to 100 range at 2 am. 1/25/07 - temp 100 range during day, temp rose to 104.7 around 6 pm, very sleepy, just stared into space, not moving much or making noise. Treated with acedamediphin and temp dropped to 100 range at 3 am.  1/26/07 - temp 100 range during day, temp rose to 104 around 6 pm, very sleepy, just stared into space, not moving much or making noise. Treated with acedamediphin and temp dropped to 100 range at 2 am.  1/27/07 - temp 102.5 during day.  Saw Dr , said she had a Vax reaction and should get over it soon.  He said he was not reporting it.  Temp went to normal at 3pm.
Patient received (Pfizer) Covid vaccine on this date at 10:25 AM. Patient alert, oriented after vaccination, walked with mother to lobby for monitoring without difficulty. Patient returned to exam room with assistance of staff member stating that she felt lightheaded at 10:28AM. Patient assisted to chair, talking to staff, then became pale, and began to lose consciousness. With assistance from their doctor, patient was lowered to floor and legs elevated. BP 89/58, P72, sp02 98% on room air. Patient pale, diaphoretic, pulse stable but thready. Once lowered to floor and bilateral lower extremities elevated, patient alert and oriented. Patient attempted to stand with assistance from staff at 10:32 and noted with loss of consciousness again, lowered to floor and bilateral lower extremities elevated by nurse and MD. Patient immediately regained consciousness once lying on floor with extremities elevated. Patient alert and oriented x3, talking with staff without difficulty, mother by side. EMS contacted for transport to ED for evaluation and treat. Patient kept lying with lower extremities elevated. Vital signs at 10:35am BP 90/60, 87, sp02 98%. Patient monitored continuously by nurse. Vital signs at 10:44am BP 97/66, P80, Sp02 100% on room air. Patient alert and talkative. Denies pain. Cool compress applied to forehead. Denies any complaints at this time. EMS arrived and patient transported to ED at 10:47. Report called to nurse in ED at 10:58am.
Rash and hives all over body. Fat lip, itchy where the rash was.
Since my second dose I have experienced painful swelling in my hands. Initially it felt as though they were swollen , now I am experiencing constant pain in my joints. I have never had any issues prior to my second shot. I have to constantly massage and exercise my fingers as they are stiff . I also experience pain at night . This has only effected all of the joints in my hands. I am a healthy 58 year old woman, physically fit and I exercise 3- 4 times a week. I recently retired and have always maintained my health.
This case was considered medically important. Additional information clarified the ear infection was an otitis media which updated the event and upgraded the event to serious for the medically important event of otitis media. Additionally reported were event details, recovery status and laboratory results. Information regarding PREVNAR 13 (syringe pre filled) was received from a healthcare professional regarding a male patient who experienced a cold and then developed otitis media/drug ineffective. The patient received a dose on an unspecified date. On an unspecified date in 2010, the patient experienced a cold and then developed otitis media. The patient recovered from the events. It was reported that the patient's mother believed that PREVNAR 13 caused the ear infection. No additional information was available at the time of this report.