chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stabbing pain around her heart area; swelling and pain at the injection site; swelling and pain at the injection site; This is a spontaneous report from a contactable consumer. This consumer(mother) reported for a 15-year-old female patient (daughter) that:  A 15-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, NDC/ Expiry Date: Not Provided) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stabbing pain around her heart area and swelling and pain at the injection site. Reporter stated that she did not knew if what she experienced was a side effect of the vaccine, but she was told to call and report any possible side effects. Reporter stated that after receiving the vaccine she started spotting and started having her period again, and she did not have her period in a long time. Asked if this had been reported before. Reporter also stated that both of her girls were 15 years old, and when they got their Pfizer Covid 19 vaccines, they both got swelling and pain at the injection site, but one of them had started to feel a stabbing pain. Clarified that one of her girls had an episode the previous day where she felt a stabbing pain around her heart area. Verified that both girls are 15. Stated, Investigation assessment was not provided. The Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In January 2023 I was extremely fatigued, and my heartbeat was erratic.  I wore a heart monitor for two weeks and nothing was found.  I will continue to wear the heart monitor each time I have other issues like this.  In March of 2023 I had the stomach flu.
I started becoming lethargic, different to talk, lightheaded, dizzy. It was treated with Benadryl.
Blood pressure increased to around 212/101; Extreme dizziness with the room spinning; Extreme dizziness with the room spinning; Sores in her mouth and on her tongue; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199), via unspecified route of administration in left arm, on 19Mar2021 at 00:45 (at the age of 65 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included hypertension (controlled with medication) and COVID-19 in Dec2020 (prior to vaccination; tested positive for COVID-19 in early December). The patient's concomitant medications included many (unspecified) medications. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021 at 07:00, the patient experienced extreme dizziness with the room spinning and her blood pressure increased to around 212/101 for most of the day and it eventually subsided later in the day and the dizziness settled down. The patient also developed sores in her mouth and on her tongue on 24Mar2021 at 07:00. They still remained the next day (25Mar2021). The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: The event Blood pressure increased has been upgraded to serious as medically significant; updated reporter information; the event term "Sores in her mouth and on her tongue" has been recoded from Sore mouth to Sores mouth; Sore tongue was deleted as an event; updated patient information (age at event and vaccination was updated from 66 to 65 years); and narrative.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient with diabetes and cancer. In 2011 the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis, and in 2015, she was vaccinated with a second dose of ZOSTAVAX (extra dose administered). Concomitant therapies included sterile diluent. On 18-OCT-2016 the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovered/resolved.
This is the second of eight spontaneous reports as received from a physician concerning a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given that with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was unknown. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
3 month old infant was inadvertently administered a dose of Kinrix; This was the patient's first dose of DTaP and IPV; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22-MAR-2024) for prophylaxis.   On 17-AUG-2023, the patient received Kinrix. On 17-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 month old infant was inadvertently administered a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: This was the patient's first dose of DTaP and IPV).  The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 24 August 2023: The pharmacist reported that 3 month old patient was inadvertently administered a dose of Kinrix. This was the patient's first dose of DTaP and IPV.  Pharmacist was unsure which vaccine the patient was supposed to have received.   The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The 3 month old patient was inadvertently administered a dose of Kinrix as first dose of DTaP and IPV which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Lump underneath injection site, which over a two day period got larger with a red ring around the lump. Pt called back and said she was allergic to MSG.
Pfizer-BioNTech Covid vaccine EAU: Dosing error During a vaccination clinic it was discovered that we were short  5 doses of the Pfizer vaccine.  We were able to obtain 6 doses per vial.  Upon examining the vials and diluents it was determined that 1 vial of vaccine was administered undiluted.  The patient received 0.3ml from the vial of undiluted vaccine.  Upon discovery, we could not determine which person received the excesive dose.
pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation.  Medical history included osteoarthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) and finasteride (PROSCAR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in left arm (Vax site) migrated down to elbow & forearm on 27Mar2021 with outcome of recovered. The patient received treatment: ibuprofen. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Started breaking out on my chest just one side of my chest; Right side is just in great big sores, it's awful; I got other problems too with my hip and leg; I got other problems too with my hip and leg; It hurts really bad; Have never been so miserable in all my life/I have been through hell about this I really have had never suffered so much in all my life; I have really bad scars left on one side of my chest; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm on an unspecified date (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included back problems and blood pressure. Concomitant medications were not reported [She stated that she takes a blood pressure medicine and stated that she have to go through my big bag of medicine]. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. On an unspecified date, the patient started breaking out on her chest just one side of her chest and could not get it away and finally got it under control. Then, her right side was just in great big sores, it was awful and she could not find a doctor to help me and it was really bad. She further stated that she have been through hell about this and really have had never suffered so much in all her life and she could not get anybody to tell what it was, neither take care of it, they had her on different medications and nothing. The patient stated that she just got other problems too with her hip and leg and it hurt really bad and had to take pain pills because of it. She had never been so miserable in all her life. The patient stated that they were just, like one day they might get better but they were just persisting. The patient had really bad scars left on one side of her chest. She went to her family doctor and he gave a cream (Unspecified Medication) and it did not do anything and she went to a dermatologist she did not help her and she went to the ER they did not help her any so she did not know what else to do. Consumer stated regarding start date of event, few days after she took it but she didnt maybe a week after she took it, she was not sure but she had it for so long she thought she was going to rot. The patient underwent lab tests and procedures which included blood test on an unspecified date and results were unknown. Outcome of the events was reported as not recovered.  Information regarding the lot/batch number has been requested.
After receiving the vaccine within 6 hours I had a fever of 102 degrees, body aches, chills, vomiting, and diarrhea. That lasted for about 5 days. Then I went into a colitis flare that lasted for about 6 months. Sometime during that 6 months I called my gastro doctor and he prescribed me a UCERIS steroid to get me out of the flare. I had caught covid in January 2022, and I was sick for about a week. I had a fever, aches, and chills, but no vomiting and diarrhea. I remained very tired after that. About 3 or 4 weeks after recovering from covid, I developed a dry cough. I was prescribed an inhaler for it. On March 26, 2022, I started having very sharp pains in my right rib. I went to the ER and the doctors had to put me on blood thinners. They found 3 blood clots in my lungs. There was 1 at the top of my left lung and 1 in the middle of my right lung and 1 at the bottom of my right lung. I had developed pneumonia as well. While being hospitalized for a week I was given IV blood thinners, IV antibiotics, and IV pain meds. I was prescribed some blood thinner pills and an inhaler to take home. I was also given oxygen but the doctor doesn't think I need it at this point because my oxygen saturation is coming back. I am going to have these blood clots for about 6 months. During that time I am going to be seeing a hematologist and pulmonologist. The doctors said that they think that the blood clots were strictly caused by covid because when they did a DNA Test on me it showed that I didn't have any traits in my DNA  that would cause  me to have blood clots. I don't carry that trait at all.
I went into the room with patient, her mother and sister. I did confirm with patients' mother that I would administer COVID boosters for both patients. The mother agreed. After administering both vaccines I had come back to my computer to chart.  I noticed at this point that only one of the patients (the sibling) needed the booster and that the doctor had ordered the original series of the covid vaccination for pt. I called the mother to inform her of what had transpired, and she understood.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K016966, expiry date: 10-MAY-2017 or GARDASIL 9 lot # K016966, expiry date: 10-MAY-2017 (dosing details were not reported). No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Dizzy; Grumpy/Cranky; His voice is totally different; stress; Headache; does not feel good; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes, He is on Metformin.; "Depression (Mental Illness)" (unspecified if ongoing), notes: Verbatim: Depression (Mental Illness); "He also a smoker, alcohol" (unspecified if ongoing); "He also a smoker, alcohol" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (1st dose., Anatomical location: right arm), for COVID-19 immunization, reaction(s): "cranky and irritable". The following information was reported: DIZZINESS (non-serious) with onset 01Apr2021, outcome "unknown", described as "Dizzy"; IRRITABILITY (non-serious) with onset 01Apr2021, outcome "unknown", described as "Grumpy/Cranky"; DYSPHONIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "His voice is totally different"; STRESS (non-serious) with onset 01Apr2021, outcome "unknown", described as "stress"; HEADACHE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset 01Apr2021, outcome "unknown", described as "does not feel good".   Additional information: He has mild limited health issues but last time we went we did not stay after the shot. He got dizzy real dizzy, dizzy in the sense reporter almost took him to the hospital and we had probably been a block or 2 of it, and he said now really fine but today he stayed 30 minutes. He did he got dizziness again but he also got bad headache, he got really what he would consider grumpy from an outside source and headache. It used to be that he would eat chips. He would just have the mood change made him toxic to being here. He was almost that bad with headache, and his voice was totally different, he does not feel good, have headache. This is just a one time, maybe its headache, maybe it is just phone making irritable, maybe it was stress going Covid shot, in fact this was that is the Covid shot, he was very adamant he was not going to get the second shot and then something changed in his mind we decide to get the shot. Another problem to know about that, he was cranky and irritable after the first shot but most of this time.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Metallic taste in mouth within 3 hours - went away after I ate. Also had extreme fatigue for 24 hours after shot
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date, when the patient was a baby, they were vaccinated with three dose series of RECOMBIVAX HB (dose, route and lot number not reported). It was reported, that recently, in 2013, the patient had the blood work completed to test for protective antibody levels for hepatitis B. The blood work came back as "non-reactive". The outcome of the adverse event was unknown. Additional information has been requested.
Onset of limping 5 days after administering MMR, DTap injection. No other associated symptoms. Noted tenderness in the left hip joint. CBC, Diff,ESR, . Pain resolved on Motrin within 48.
Patient admitted under observation on 10/04/2021 due to Acute respiratory failure with hypoxia 2/2 COVID pneumonia. Patient was tested for COVID-19 and was positive on 10/04/2021.
Information has been received from a health professional concerning a 66 year old female who on 27-FEB-2008 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot #656233/0200U). There was no concomitant medication reported. On 27-FEB-2008, the patient had an injection site reaction after receiving pneumococcal 23v polysaccharide vaccine. She stated that her left arm was swollen from upper shoulder to elbow. She experienced wheezing and went to the emergency room, but was not hospitalized. The physician was requesting a lot check of this vaccine due to patients having adverse experiences. At the time of this report the patient's outcome was unknown. There was no product quality complaint involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
After pt was vaccinated and sitting in her monitoring area pt became nauseated and complained of head ache. Vitals taken 124/62 pulse 62. Elevated pt?s legs, cold compress given, fan applied to body.  After 10 min. Pt stated she felt better. After 30 min. Pt had no symptoms and was allowed to leave.
Acute ischemic stroke - treated and discharged. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
pt recv vax 3NOV98 & began to exp lt & rt arm pain & distal weakness that persists;tennis elbow strap & PT recommended;
I got up in the morning and I felt peculiar. After a while I started feeling worse, my heart was beating really fast. I took my blood pressure and it was 170 over something high, and my pulse ox was so high it wouldn't register. I called emergency number, and while in the ambulance they did something that stopped my heart twice. i was in the hospital for 4 days. While there, a doctor offered an ablation but that I could also take medicine to help. Right now I think the medication is preventing me from sleeping so I might have to go back and have the ablation. I don't think it had anything to do with the vaccination but one of the first questions they asked was if I had ever had COVID19 which I have not.
Facial paralysis; This is a spontaneous report from a contactable Pharmacist.   A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899, Expiration Date 30Mar2021), via intramuscular, on 17Dec2020 (at 15:35), at single dose of 0.3 mL for COVID-19 immunisation. The patient was vaccinated at hospital, age at vaccination was 70-year-old. Vaccine location was deltoid but unsure which deltoid. The patient did not have a relevant medical history and concomitant medications. Pharmacist said that after vaccination, she waited to be monitored the standard 15 minutes at hospital and then when she got in the car and was on the way home like 20 minutes later she had brief episode of what the patient described as facial paralysis. It was like the side of her face in one area felt funny, it felt numb and it was not anywhere else on her face. It lasted the 20 minutes and then went away. The patient had recovered from the events on 17Dec2020. The pharmacist queried if the patient can proceed with the 2nd dose of the vaccine.  The reporting pharmacist considered the event 'facial paralysis' as non-serious.; Sender's Comments: A possible causal relationship between acute onset of facial paralysis and BNT162B2 cannot be completely ruled out considering the temporal relationship and the known adverse event profile of the suspect vaccine.  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.
Stomachache and nausea  Headache Fatigue Brain fog  Vertigo
Two days subsequent to receiving the third dose of Lymerix, the pt developed a four inch red rash at the injection site. As of 09/07/2000 the outcome of the event is ongoing.
swelling in arm pit-sore-uncomfortable;had pain under one arm earlier in this yr;MD said r/t ligaments
I started having headaches on the 30th of March; I had a headache every day until the 13th of April. Light headedness; palpitations and shortness of breath. I'm on a heart monitor of my heart until tomorrow afternoon. I had an ECHO of my heart today and will know results next week. Tylenol  and was given prescription of  Fioricet to treat .I went to  ER - I went to the labor and delivery triage at the hospital -on April 1st  , Doctor (April 6th) and Cardiologist (on April 13th). I still have shortness of breath, palpitations and lightheadedness. Headaches have stopped.  Pregnancy history: This is my only pregnancy; Estimated DoB - June 25, 2021
After enduring side effects of my third Moderna shot on a Sunday (headache, low-grade fever) for 1-2 days (plus rash on inner right elbow and swollen lymph nodes under left armpit for 5 days). I started to get symptoms for Covid that Wednesday, 4 days after the booster. Covid symptoms that began with burning throat, then fever, fatigue, light body aches.  I  got tested the next morning (Thursday). Rapid test  came back negative (per Lab). Covid symptoms started to abate by Friday night.  Got my PCR result (from same sample on Monday -- positive for Covid.  I have no pre-morbidities and am normally in excellent health. Just wanted to report that the public NEEDS to know about these breakthrough cases so we can prevent them or study the details.