chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RECEIVED VACCINES AT APPROX 1430 ON 09/09/09 APPROX 11 HOURS LATER PATIENT SENT TO ER FOR POSSIBLE SIEZURES.  NO PRIOR HISTORY OF SEIZURES.PATIENTS JEARKING MOTION LASTED ABOUT 20 MINUTES.  WHILE IN ER PATIENT HAD JERKING MOTIONS AGAIN.  ATTENDING WAS CONCERNED ABOUT SEIZURES VS INFANTILE SPASMS
5 hours post vaccination, started general body aches, headache, chills, tiredness. By 9 hours post-vaccination, severe headache and body aches, very tired and weak. 15-hours post-vaccination, fever of 99.8, severe chills, sweating, body aches, and severe headache. Took 2 extra-strength acetaminophen. 16-hours post-vaccination, headache, fever, and chills, subsided. General achiness continued through 57 hours post-vaccination.
Information has been received from a medical assistant via a company employee referring to a 14 years old female patient. The patient's medical history and concurrent condition were not reported. Concomitant therapies included ABILIFY, VYNASE and RETIN A. On 20-JUL-2016, the patient was vaccinated GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route not reported). On 17-AUG-2016, the patient returned to the office and complained about a knot and a bruise at the injection site that was warm to touch beginning on an unspecified date in 2016 after receiving GARDASIL 9. No treatment was given for the events. The knot lasted a couple of weeks. The outcome of the events was unknown. The causality between GARDASIL 9 and the events was not provided. Additional information has been requested.
Client states he has been having chest pain on and off for 3 days. No strenuous exercises or anything different. No history of Cardiac issues or elevated BP.
I started to feel sick on 02/22/2023. I tested positive for COVID-19 on 02/23/2023. I had a telehealth visit on 02/23/2023 spoke to a physical assistant and they gave me a prescription for PAXLOVID and took the course of this medication which made me feel better. I had a very quick onset of fever and body aches. I also did lose my sense of smell. I took a home test on 02/23/2023 which was positive. I continued to test positive for 10-11 days. On the 11th day I tested negative which was on 03/06/2023. I am always complying with masking requests.
About 20 min - 30 min after leaving I felt my throat getting very tight.  As tightness progressed, tongue started also getting itchy.  I could breath well despite tightness.  Face was also itchy as day went on but called Dr, took benadryl.
86-year-old male past medical history:  -cirrhosis liver; decompensated;  (outpatient paracentesis)  -CHF  -coronary artery disease  -mitral valve ring  -hypertension  -atrial fibrillation; paroxysmal (warfarin)  -chronic anticoagulation (Coumadin)  -echocardiogram; 02/03/2021: LVEF:  50%; severe tricuspid regurg;  -received a Johnson & Johnson vaccine in February  Presents to the hospital with cough, difficulty breathing.  Onset roughly 2 weeks ago. Reports that he was diagnosed with COVID-19.  States that everyone in his household was tested (+) for COVID-19.  Recently had wife passed away from COVID-19.  On admission patient was found to be atrial fibrillation with RVR (122).  Hemodynamically stable.  Met sirs criteria infectious source (tachycardia; tachypnea; (+) COVID-19).  ABG showed no hypoxia.  Patient was started on 2 L. as he was struggling using accessory muscles for breathing.  Identified mild anemia; elevated troponin (40); EKG showed no ST segment changes or T-wave inversions; atrial fibrillation identified.  Chest x-ray showed elevation of right hemidiaphragm.  Streaky right basilar opacities.  Additionally, patient reports that he gets outpatient paracentesis roughly every 2 months.  It has been 2 months since his last paracentesis.
Felt real hot, disoriented, dizzy,nauseated, dry mouth, itchy red face, SOB, but no wheezes.
Pt reported swelling in arm, itchy, red and painful. continuing for 3 days so far.  pt took allegra but didn't help. arm is less swollen after two days
slight sore arm; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6206) via an unspecified route of administration in the right arm in Mar2021 as a single dose for COVID-19 immunisation. Medical history included lung cancer several years ago, surgery, multiple sclerosis, mild chronic obstructive pulmonary disease (COPD), arthritis, and irritable bowel syndrome, all from unknown dates and unknown if ongoing. Concomitant medications included phenazepam and nitrazepam, both from unknown dates for unknown indications. The patient reported she received her first dose on a Wednesday, three weeks earlier as of 05Apr2021, and only had one side effect, a slight sore arm. The patient received her second dose on 31Mar2021 at 08:30 for COVID-19 immunisation. The patient inquired if she should get a booster when it comes out. The clinical outcome of slight sore arm was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to 15 month old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 07-OCT-2016, the patient was vaccinated with improperly stored and expired dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609:Original Case : 1610USA004609.
Injection given 8/24/04, mom called 8/26/04 with message stating: the right thigh red, swollen and warm. I do not know what treatment was prescribed. Incident discussed with patient by doctor.
This spontaneous report as received from a registered nurse refers to a 24-year-old male patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported. On 07-JAN-2019, the patient was vaccinated with VARIVAX subcutaneously, (lot # R019235, expiration date: 04-JUL-2020), (exact dose and injection site were not provided), for prevention of varicella. On 07-JAN-2019, the patient began experiencing redness, warmth, itching, and mild pain at the injection site. On unknown date, the patient sought medical attention via visit in physician's office. The patient received treatment which included an unspecified anti-histamine and an unspecified anti-inflammatory medication. The outcome of the events was reported as recovered on unknown date in January 2019 (reported as a few days after vaccination). The relatedness between the events and the suspect vaccine was not provided. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1902USA004146:US-009507513-1902USA006028.
This spontaneous report received from a registered nurse, via company representative, refers to a 15 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. No adverse effects were reported. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter.  Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Itchy all over body. Patient took benadryl within 24 hours and symptoms resolved within 48 hours of start.
garbled speech; spasms; Mouth/lips twitching/twitching; arms rigid up toward face; lips blue; rapid breathing; deep sleep after; glazed look; not responding; bite tongue; This is a spontaneous report received from a contactable healthcare professional also reported as a nurse. A 93-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN5318) intramuscular, administered in Arm Left on 28Feb2021 at 14:30  as SINGLE DOSE for covid-19 immunisation  Facility where the most recent COVID-19 vaccine was administered was a Home/Facility. Medical history included cerebrovascular accident 'CVA 8 months ago' from Jul2020 to an unknown date , atrial fibrillation from an unknown date and unknown if ongoing. The patient has no known allergies. Historical Vaccine included BNT162B2 Dose 1, Lot number EL9621, Administration date 07Feb2021 at 14:00, Intramuscular, in the Left arm for Covid-19 immunization. Concomitant medication included asa (ASA); levothyroxine (LEVOTHYROXINE);metoprolol (METOPROLOL); bupropion (BUPROPION); docusate sodium (COLACE); apixaban (ELIQUIS); iron (IRON); latanoprost (LATANOPROST); omeprazole (PROTONIX [OMEPRAZOLE]); timolol (TIMOLOL); paracetamol (TYLENOL). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 2021, The patient experienced spasms,  mouth/lips twitching/twitching,arms rigid up toward face, lips blue, rapid breathing, deep sleep after, glazed look, not responding,  bite tongue and on Mar2021 garbled speech. on Mar2021. The events Mouth/lips twitching,arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, garbled speech was considered Disabling/Incapacitating. Clinical course was reported as follows  Mouth/lips twitching, arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, same repeated 4 hours later and then again 1 hour after that. next day garbled speech, not exhausted and stayed in bed 4 days. It was unknown if treatment was give for the events.  The clinical outcome of the events was recovered with sequelae.     .
Headaches; so tired I can hardly get out of bed.; This is a spontaneous report from a contactable 69-year-old female consumer reported for herself. A 69-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FC3180) via an unspecified route of administration, administered in Arm Left on 06Aug2021 13:00 as DOSE 1, SINGLE (at the age of 69-year-old) for covid-19 immunisation. Medical history included drug hypersensitivity, ongoing known allergies: Sensitive to myacins. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received blood pressure meds acid reflux and thyroid med within 2 weeks of vaccination. On 07Aug2021 at 09:00, patient experienced headaches and felt so tired that she can hardly get out of bed. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jun2021. Patient did not received any treatment for events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
HOT AND COLD FLASHES; STOMACH PAINS; REALLY BAD BACK PAIN; NECK PAIN; CHILLS; REALLY BAD HEADACHE; EXHAUSTION; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach pains. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced hot and cold flashes. On 16-MAR-2021, the subject experienced stomach pains. On 16-MAR-2021, the subject experienced really bad back pain. On 16-MAR-2021, the subject experienced neck pain. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced really bad headache. On 16-MAR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold flashes, and chills on 18-MAR-2021, had not recovered from really bad headache, exhaustion, really bad back pain, and neck pain, and the outcome of stomach pains was not reported. This report was non-serious.
A 62 year old female pt was treated with 6 weekly Oncotice instillations for bladder cancer from the end of Oct 2005. A few days after the first instillation she presented with blood in her urine, burning during urination, flu like symptoms (chills, tiredness, muscle ache), nausea after eating, skin irritation and hair loss which have currently not yet resolved. Dysuria.
pt recvd vax & exp joint pain & swelling which moved to elbows, knees, & to ankles; pt seen by allergist; pt dx by an autoimmune disease precipitated by hepatitis B vax;
sore arm near injection site; This is a spontaneous report received from a contactable consumer (patient herself). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247, Expiry date: Unknown) administered intramuscularly in arm left on 21Jan2021 09:00 as single dose for COVID-19 immunisation. Patient was not pregnant. Family history included Kidney-related health issues and patient's medical history was none. There were no concomitant medications and no prior vaccination within 4 weeks. On 21Jan2021 09:00, the patient experienced sore arm rear injection site. Therapeutic measures were taken with Advil. The outcome of sore arm rear injection site was recovered on 24Jan2021.  No follow-up attempts are needed. No further information is expected
normal pain; rash developed that extended to my elbow; was tender; rash developed that extended to my elbow and was itchy / itchiness; rash developed that extended to my elbow and was warm / warmness; redness of the rash is slowly fading; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain, rash, tenderness, itchy rash, feeling of warmth and red rash. On an unknown date, the outcome of the pain and tenderness were unknown and the outcome of the rash, itchy rash and feeling of warmth were not recovered/not resolved and the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the pain, rash, tenderness, itchy rash, feeling of warmth and red rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had a normal medical history and had not reacted to vaccines previously. After receiving Shingrix, the patient experienced the normal pain, but a rash developed that extended to the elbow and was tender, warm, and itchy. The rash and warmness were still there on the day of reporting. The redness of the rash was slowly fading, as is the warmness and itchiness. The patient feels fine, otherwise. The reporter asked had this type of reaction been reported previously and was it normal or, should the patient be concerned.
-Slight HA occurring minuted after injection -Woke @ 0430 8/28 to extreme HA pain (9/10) to base of head/occipital area -Within half hour has emesis X 2 with slight nausea & diarrhea -Took Advil (no relief) Took APAP (no relief) -Unable to hold down food or water -Emesis after each dosing of OTC pain medications -HA pain lasted at 7-9/10 pain through the rest of the day, until approx 1600 -3 more episodes of emesis with continued diarrhea throughout the day -Upon waking 8/29 I experienced right arm pain to elbow, on the top side of my upper arm, below the deltoid with calor, no redness, with limited ROM (not just site pain)  -8/29 All day experienced generalized fatigue and body aches -8/30 All sx resolved -
Ears filled with fluid, tongue swelling, lips swelling, face and neck swelling, rash all over body, itch all over body, burning skin after 1 week.  Multiple episodes (at least 10) over the course of 3 weeks - resulted in 3 trips to the ER.  Received injected or oral steroids at the ER.  This caused loss of work and a great deal of stress.  Was put on a course of oral steroids and antihistamines by allergist following ER visits.  Had a prior reaction to the flu shot in October 2020.  Everything above but the rash and itching.  also resulted in a trip to the ER
Tinnitus - ringing in the ears.  I was working from home that week while my family was out of town and noticed the intensity of ringing ramp up over the course of the week.  I received my shot on Monday afternoon and by the following Sunday morning, the intensity was so great that it was difficult to concentrate/comprehend what was said during a church service.  I saw my ENT doctor the following week and got a hearing test, which picked up some slight hearing loss.  Since then, intensity has fluctuated day to day and in different environments.  The left ear is worse than the right ear.  At the time of this report, I've experienced several days of consecutive ringing that has been about the most intense that I've experienced.  I've been told there is no effective treatment for the condition, but I've utilized lipo-flavonoid with mixed results.  Ringing seems to be less intense after nights where I've slept well, but that is increasingly challenging.
Difficult breathing, confused, disoriented, injection site swollen the size of a 16" baseball and knotted, hurt, burned and burning down arm and up to shoulders. Had to be monitored in ER. Severe reaction to shots. Got a shot of Benadryl and took 150mg of Benadryl for 3 days.
Patient previously vaccinated with Moderna vaccine asked to received the Pfizer booster . Patient reported that he felt weak heart palpitations and dizzy right after. Patient has a hx of HTN which is evident in vitals assessed by covid vaccine clinic staff. Vitals were as follows 165/85 86bpm 97% on RA 18rr. Patient states "I didn't take my medicine today and I didn't have any thing to eat since about 130am." pt was given a light snack and allowed to rest Vitals were assessed again after an hr and showed no change. Patient stated he felt better and proceeded to get up but he experienced a headache and had to sit back down and wait for his Wife to come to pick him up. vitals were assessed again in an hr and the diastolic pressure had risen to 100. patient refused medical attention outside of the vital assessment and stated he will be fine after he takes his meds and eat. Pt's wife arrived and he left the facility.
This report was received from GlaxoSmithKline and was assigned manufacturer report number A0969013A for KINRIX. This case was reported by a healthcare professional (the patient's aunt) via a sales representative, concerning a 6 year old male patient who on an unspecified date was vaccinated with a dose of PROQUAD into the left arm (dose, route and lot number not reported). Secondary suspect therapy included a dose of KINRIX (0.5 mL, route and lot number not reported) on an unspecified date into the left arm. According to the reporter, both vaccines were administered at different site in the left arm. It was reported that less than one day after vaccination, "within 24 hours", the patient experienced arm pain after injection (also reported as "severe" pain in left arm), arm red after injection (also reported as redness and swollen from the left shoulder to elbow), swelling of arm following injection (also reported as redness and swollen from the left shoulder to elbow) and skin rash on injection area (also reported as "looks like a diffuse rash from left shoulder to elbow"). The patient was taken to the emergency department and was treated with NSAID, prednisone and antihistamine. The patient was seen by his pediatrician the next day and the symptoms were improved. At the time of reporting the events were improved. Arm pain after injection (also reported as "severe pain in left arm), arm red after injection (also reported as redness and swollen from the left shoulder to elbow), swelling of arm following injection (also reported as redness and swollen from the left shoulder to elbow) and skin rash on injection area (also reported as "looks like a diffuse rash from left shoulder to elbow") was considered to be disabling and clinical significant or requiring intervention by the reporter. This was originally reported by a health care professional/consumer (patient's aunt). No further information is available.
Passed away; Respiratory failure; Congestive heart failure; Rash; Erythrodermic psoriasis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (Dose: 01, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "Passed away"; RESPIRATORY FAILURE (death, medically significant), outcome "fatal"; CARDIAC FAILURE CONGESTIVE (death, medically significant), outcome "fatal", described as "Congestive heart failure"; RASH (non-serious), outcome "unknown"; ERYTHRODERMIC PSORIASIS (non-serious), outcome "unknown". The patient date of death was unknown. Reported cause of death: "Congestive heart failure". It was not reported if an autopsy was performed.  Clinical course: Patient passed away as a result of respiratory failure, due to congestive heart failure, due to a reaction from covid 19 vaccine. (That is from his death certificate). He apparently had a rash that was diagnosed as erythrodermic psoriasis, a rare psoriasis that his doctors said was a reaction to the vaccine. He had just had his second dose of the pfizer vaccine when the rash started. He had no pre existing conditions, no other health issues. He was 73 when he passed away.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Congestive heart failure