chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 22Jun2021 at 17:30 as dose 2, single (Lot number: Ew0180) at the age of 16 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0180, in right arm, at 06:00 PM), administration date: 27May2021, when the patient was 16-year-old, for COVID-19 immunisation. The following information was reported: SEIZURE (medically significant) with onset 05Jan2023 at 22:30, outcome "not recovered". The event "seizure" required emergency room visit. Clinical course: No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No other medical history.
Information has been received from a medical assistant referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of VARIVAX (dose unknown, lot # K002913, expiration date 26-FEB-2016). No adverse effect was reported. Additional information has been requested.
patient wanted Johnson & Johnson?s Janssen COVID-19 Vaccine but was accidently given Pfizer COVID19 vaccine instead
Lack of strength, double vision, body ache,  for 6 days  Loss of taste on going
Information has been received from a physician concerning a 17 month old white female who on 4/8/99 was vaccinated with MMR. Concomitant therapy included the 3rd dose of poliovirus vaccine and the 4th dose of DPT. On 4/11/99, the pt experienced macular rash, red eyes, irritability, and was not feeling well. The pt also "wanted to be held". The rash spread and persisted until 4/16/99. The pt also experienced a fever from 4/17/99 to 4/19/99 up to 102F. A visit to a physician was required. The pt recovered on 4/20/99. No further information is available.
Information has been received from an approximately 69 year old female with high blood pressure and a history of an unspecified "reaction to the smallpox vaccine", who on approximately 19-NOV-2007, was vaccinated with 0.5 ml of Zostavax (Oka/Merck).  Concomitant therapy included two unspecified high blood pressure medications, and vitamins.  On approximately 19-NOV-2007 3 to 4 hours post vaccination with Zostavax (Oka/Merck); the patient developed an elevated temperature and headache.  A couple days later, on approximately 21-NOV-2007 the patient developed a rash on her torso and legs, along with pain in her hands and feet, and swelling in her ankles.  It was also reported that the patient developed a low grade fever which lasted about four weeks.  The patient went to the emergency room (ER), but was not admitted.  Unspecified blood work was obtained, of which the results were not reported.  At the time of reporting the patient was recovering.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information has been received from a physician concerning a 71 year old female with blood pressure high and no pre-existing allergies or drug reactions who on approximately 26-NOV-2007 was vaccinated intramuscularly with a first dose of Zostavax (Oka/Merck) (Lot # 658361/1090U).  There was no illness at the time of vaccination.  Concomitant therapy included aspirin, calcium (unspecified) (+) vitamin D (unspecified), UNIRETIC and "MUR".  On 27-NOV-2007 the patient developed a rash, fever, myalgia, fatigue and arthralgia.  The patient had also reported that she had developed a headache and temperature 3 to 4 hours after vaccination, and that a low grade temperature remained for about 4 weeks.  The patient had also reported developing swelling in her ankles, of which the outcome was not reported.  The physician reported that the patient had no prior adverse events following prior vaccinations (also reported by the patient as having had an unspecified "reaction to the smallpox vaccine").  The physician reported the patient was recovered (on approximately 18 DEC 2007), and that her rash, fever, myalgia, fatigue and arthralgia lasted for three weeks.  No further information is expected.
WAS GIVEN AN UNDILUTED VERSION OF THE PFIZER PEDIATRIC (5-11YR)
Information has been received from a nurse referring to an unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, expiration date, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Fatigue, nausea, headache, chills, shortness of breath, rapid heart rate at times, lymph nodes swollen under arm and breast area. Went to ER 09/28 to get chest X-ray and bloodwork. Everything was normal per ER doctor. She has continued to have shortness of breath. Other symptoms are not really an issue now, but the shortness of breath and rapid heart rate is an issue.  Lymph nodes still swollen and sore. Following up with pediatrician tomorrow 10/01.
Rt arm swollen and knot the size of a quarter at first on5/13/09 pm.  Arm s/s increased and pt seen in ER and tx with Benadryl.  Mom reported on 5/15/09 am knot increased to size of a hamburger patty and became hard to touch and site was also red and warm to touch. Pt was seen in Doctors office that afternoon. Arm had improved size decrease slightly, not as hard to touch, not warm to touch.  Mom to continue with benadryl and warm compresses and rtc if site worsens.
Tenderness in arm; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (Tenderness in arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Smoker.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced TENDERNESS (Tenderness in arm). At the time of the report, TENDERNESS (Tenderness in arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information were not reported.   This case was linked to MOD-2021-176293 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event, a causal relationship cannot be excluded.
Fever; vomiting; welts that appeared on his hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 7 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; URTICARIA (non-serious), outcome "unknown", described as "welts that appeared on his hands and feet". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
2 days after receiving my 2nd covid booster shot I experienced total deafness in my left ear. my first 3 shots were Moderna, this 2nd booster was Pfizer.   I have seen my regular physician and an ENT for evalutation.  I have still not gotten my hearing back.
My COVID-19 symptoms were  stiffles, fever, fatigue,and dry cough. I had a telehealth visit and was prescribed Paxlovid. My fever went away within 24 hours, but my cough lasted for a couple days. After I finished my Paxlovid I had symptoms that was similar to thrush and vaginal yeast infection. When I talked to the doctor for it and the doctor prescribed me medication. My vaginal infection when away but what seemed like thrush lasted longer. Doctor said it might have something to do with COVID-19.
pain at the injection site; swelling at the injection site; redness at the injection site; had chills; night sweats; fever; headache; Body aches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 14:00 (Lot number: FJ1614) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: other_medical_history Hashimoto; insulin resistant; "Insulin resistant" (unspecified if ongoing), notes: other_medical_history Hashimoto; insulin resistant. Concomitant medication(s) included: DROSPIRENONE; ETHINYL ESTRADIOL; METFORMIN; SYNTHROID. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Jan2022, outcome "recovering", described as "pain at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset 17Jan2022, outcome "recovering", described as "swelling at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 17Jan2022, outcome "recovering", described as "redness at the injection site"; CHILLS (non-serious) with onset 17Jan2022, outcome "recovering", described as "had chills"; NIGHT SWEATS (non-serious) with onset 17Jan2022, outcome "recovering", described as "night sweats"; PYREXIA (non-serious) with onset 17Jan2022, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 17Jan2022, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 17Jan2022, outcome "recovering", described as "Body aches". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema, chills, night sweats, pyrexia, headache, pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Pt told vaccinator that he had never had any other covid vaccines. Stated this was his first vaccine. Manager looked up pt in system after the pt had left and found 3 doses prior to today's dose. Pt did not qualify for second booster. Under 50yo and denied immunocompromise. Pt now has 4 doses on record.
Headache, chills , fatigue, joint pain, swelling and redness at injection site Granuloma annulare
then was tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (Brother-in-law):  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization; and patient was taking hydrocortisone, neomycin sulfate, polymyxin b sulfate (CORTISPORIN, lot number unknown), via unspecified route of administration, from an unspecified start and stop date, for an unspecified indication. The patient medical history and concomitant medications were not reported. The reporter stated that patient was exposed and 2 days later got the vaccine and then was tested positive for COVID. The reporter stated that the patient was in ER at the time of reporting and wanted to know if the vaccine would help him. The reporter wanted to know if patient should get the second dose. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Positive on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
By the evening time patient began developing a fever of 102, he would also not eat. We knew he had his shot that morning so didn't think too much of this. Wednesday patient was less than his normal energetic self and continued to run the 102 fever, my husband called the doctor to alert them of this. They said they would follow up again on Thursday. Wednesday evening patient's fever was still hovering around 102, we were giving him TYLENOL. We gave him the normal shower he gets every evening and he was acting very weird in the warm shower, kept shivering, and shaking his head. When I took him out of his shower he's usually very excited to dry off and get his pajamas on, but he kept shivering and laid his head on my shoulder and closed his eyes. I took him to my bed like I normally do to get him dressed and he immediately went to sleep (undressed, etc.), This is EXTREMELY not normal for him, he usually gets dressed, runs across the bed to kiss his daddy and hops in my arms to go in his room. I was so worried I started crying, my husband came over, picked him up, tried to stand him up and he kept acting like he was completely in a deep sleep. That's when I decided he was going to lay with me for a while. We tried to give him his warm milk that he drinks every night and we couldn't get him to take it. I ended up having him lay on my chest for a while, but he was completely out of it. I laid him in his bed about an hour later because he has a breathing monitor so I knew it would monitor him while he slept. Today, Thursday November 15, he woke up again with a 102 fever. My husband called the doctor and they said it had not been a full 48 hours yet, to let that occur (even though it has been since the shot). We are continuing to monitor him. This is NOT normal for my son at all.
Hives on both arms, both legs and feet. Becomes itchy and swollen when I scratch it.  Started one day after vaccine and still have rash until today. No improvement and still very itchy.
Fever over 101.0, vomiting, body aches, chills, described as very bad pounding headache.    Fever began at approximately 10:00 pm 6/23 same day as vaccination. vomiting began approximately 2 am ending by morning.  Fever chills headache continued until 6/25.   Conditions subsided by the evening of 6/25. Minimal effects by bedtime, tired, some body aches.   Extra strength Tylenol was used for treatment
Pt. received the 3rd Pfizer vaccine.   He was told to wait 15 minutes.  Within around 10 min. he complained of throat tightening
Pt had DTP #2 approx 8PM 25MAR92 & @ approx 10PM pt had a 45 min episode of afebrile high pitched screaming & 6 occasions of myoclonic arm jerk; next noc pt had 40 min episode of screaming-otherwise fine & fine since then;
After showering I noticed a rash over his entire chest and stomach in splotches with dry sore patches. Checked Groin and underarms Confirmed there also. Not sure what the rash is at this point.
Lightheadedness Shortness of Breath near syncope, Very sleepy 4 trips to ER at 2 different hospitals. One admission for 2 days and one admission for 5 days Symptoms still appearing upon discharge
Patient had a fainting episode and felt faint after receiving flu vaccine and walking for a short distance.  Patient was then laid on the floor and the legs were elevated.  He had a fear of needles but had not fainted before after receiving any other vaccinations.  Only one other fainting episode had occurred before after giving blood.  Patient then laid on the ground for around 10 minutes or so and sat for another 10.
Bell's Palsy caused the side of my face to swell up and droop on one side; Eyes have been bothering him and he is blinking; Can't talk very good because his lips are swelled up/hard to talk; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM9809/expiration date: not provided), via intramuscular route of administration, on 04-FEB-2021 at 14:30 (at the age of 78 years old) 0.3mL as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included patient was diabetic since an unknown date and has psoriatic arthritis. Concomitant medication included infliximab (REMICADE) infusion every 8 weeks for psoriatic arthritis and cetirizine hydrochloride (EQUATE ALLERGY RELIEF). The patient had infliximab infusion the morning of 04Feb2021, prior to receiving the vaccination and was told that infliximab would not be a problem with receiving the vaccination on the same day. On 07Feb2021, the patient went to the emergency room due to Bell's palsy, which was described as swelling of lips, nose, mouth, and side of face and stated that he can't talk very good because his lips are swelled up/hard to talk and his eyes have been bothering him and he is blinking. The patient stated, "I went to the emergency room at a hospital and what they said is totally unrelated to the COVID shot I got. In the meantime, few days after I had the shot, I had somehow got Bell's palsy caused the side of my face to swell up and droop on one side. I just wanted to get back to you so you knew that was not some reaction to the COVID shot, it was something else." Treatment for the event Bell's palsy included took Allergy Relief Equate 25mg ultra tablet and another allergy pill and it did not help swelling of lips, nose, mouth, and side of face. Relevant tests included blood work on an unspecified date in 2021 "two weeks ago" that was all good. The outcome of the events Bell's palsy, eyes have been bothering him and he is blinking and hard to talk was unknown.; 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 event Bell's palsy cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant of my body, in arm and back (spine); Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; occasional heat sensation; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 26Feb2021 17:30 at single dose in Right arm for COVID-19 immunisation. There was no medical history, no Allergies to medications, food, or other. Concomitant medication included metformin, fish oil, colecalciferol (D3) within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) at the age of 42-year-old, on 29Jan2021 17:30 at single dose in Left arm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe nerve pain throughout right upper quadrant of her body, in arm and back (spine), began the afternoon the day after the second shot on 27Feb2021 03:00 PM and progressed throughout the day, until almost unbearable that evening, even with 800mg ibuprofen.  Pain was similar to pinched nerves, with pain, tingling, occasional heat sensation, as opposed to that of a pulled or sore muscle. The patient could not lay in bed that evening and had to sleep upright in a chair with a pillow under her elbow to get minor relief. This pain continued on day 3, but was starting to lessen slightly. Day 2 (28Feb2021), the patient also developed significant pain in right armpit lymph node area, becoming more intense on day 3. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "severe nerve pain throughout right upper quadrant of my body, in arm and back (spine)", "pain similar to pinched nerves, with pain, tingling" which included 800mg ibuprofen. There was no treatment received for the remaining events. The outcome of the events was unknown. The events were reported as non-serious.
After receiving Pfizer vaccine number 3, the patient stood up, and approximately 20 seconds appeared to faint.  A MD stat was called. She became responsive approximately 3 seconds after falling. She was assisted to a wheelchair and placed on a gurney. She was evaluated in the clinic by the ED staff team, the episode was determined to be a vaso-vagal episode. She was able to ambulate with a stable gait upon leaving the vaccine clinic.
pt recv vax NOV96 & 10JAN97 eyes & skin appeared jaundiced;had dec appetite & fatigue;lab eval 26FEB97 revealed elevated liver enzymes, positive anti-smooth muscle antibody, positive ANA & elevated ESR;severe autoimmune chronic hepatitis
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.    On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of Took 2 advils. At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Body temperature: 100 (Inconclusive) 100.         No concomitant medication information provided.
difficult to left arm due to pain caused by IMZ the next day ,  pain  has become less severe after physical therapy. The patient still has pain now
Vaccines 10/28/2002. By 10/30/2002 entire right upper arm swollen, very tender and 5cm red blotches to elbow. Injection site un remarkable, no adenopathy. 11/01/2002 transient bruises right upper arm, no redness, still very sore. Pneumovax given right arm 10/28/2002- returned 10/30/2002 on set with rash 10/28/2002 night.
This spontaneous prospective pregnancy report was received from a healthcare worker refers to a 23 year old female patient. No concurrent condition or medical history was reported. On 22-FEB-206, the patient was vaccinated with GARDASIL (lot # K016966, exp. 10-MAY-2017, dose 2, dose and route of administration not provided). No concomitant therapy was reported. It was reported that the patient was given pregnancy test on 22-FEB-2016, prior to vaccination, which cam back negative. The healthcare worker reported that on 01-MAR-2016, the patient administered a home pregnancy test which resulted in a positive result. The patient was currently 9 weeks gestation. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.