chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LTC Pharmacy was notified of a potential vaccine related hospital admission on 3/8/2021. The following information was gathered from discussion with RPH at Hospital. The patient received second dose of Pfizer COVID vaccine on 2/26/2021. The patient then had nausea, vomiting, and poor oral intake. On 2/27/2021, the patient went to the bathroom and while on the toilet, had a vasovagal event which led to her hitting the side of the face while falling. Patient was then taken to the hospital for evaluation. The patient does have a pacemaker but the cause of the event was determined to likely be due to dehydration. Lab work was performed and pertinent lab values include: potassium of 3.1, SCr of 0.8, and BUN of 13. The patient received potassium supplementation and IV hydration in the hospital. Patient was discharged on 2/28/2021. Of note, the patient does have a pacemaker and a follow-up appointment with cardiology to evaluate the pacemaker was scheduled upon discharge.
Palpitations, nausea, vomitedx1, body aches, dizziness, chills
Blanching, punctuate, erythematous rash on torso, back & proximal extremities. No vesicles no crusted lesions.
Arm very red, swollen, hot to the touch, clear line of demarcation between swollen and non-swollen areas
Pfizer reconstitution done incorrectly with only 0.9ml NSS instead of 1.8ml.  Double dose of vaccine presumably given.
Sterile water used as diluent rather than meningococcal liquid component; dose will need to repeated.
COVID-19; Vomiting; Horrible taste is mouth; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Horrible taste is mouth), COVID-19 (COVID-19) and VOMITING (Vomiting) 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 reported.    On 20-Apr-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced TASTE DISORDER (Horrible taste is mouth) and VOMITING (Vomiting). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 02-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, TASTE DISORDER (Horrible taste is mouth), COVID-19 (COVID-19) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was reported with no onset date; hence latency to the third dose of mRNA-1273 vaccine cannot be assessed. No SARS- CoV-2 test was reported. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 02-May-2022 for COVID-19, at an unspecified dose and frequency. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was reported with no onset date; hence latency to the third dose of mRNA-1273 vaccine cannot be assessed. No SARS- CoV-2 test was reported. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 02-May-2022 for COVID-19, at an unspecified dose and frequency. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Rash, Hives,  2 hours after vaccine began itching and hives.  Had over her body, face and scalp but no respiratory distress.
Headache, Myalgia & NauseaVomiting Narrative: Mild headache, myalgia, fatigue 09/01/2021 which worsened to severe 09/04/2021. Nausea severe 09/04/2021. Did not seek medical attention for symptoms, (for the most part) since resolved continued fatigue.
She had red, swollen itchy bumps starting around Aug 26 on soles of feet and lower legs, and August 16 was her 2nd COVID dose.  She seemed itchy after the 1st dose, in retrospect.
pt recv vax 31JUL98 & exp erythema near the inj site;
A non-serious spontaneous report of tender vesicle lesions on fingers, tongue and inside her mouth and fever has been received from a registered nurse concerning a 13-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 13-Nov-2009 for an unknown indication. Next day on 14-Nov-2009, the patient experienced fever and tender vesicle lesions on fingers, tongue and inside her mouth. The vesicle lesions were approximately two to three millimeters on her fingers, smaller on her tongue and inside her mouth. The outcome of fever was resolved while the vesicle lesions on fingers, tongue and inside her mouth were not resolved.
Right after I received the vaccine I went into to 15 minute observation area. Once I sat down I  felt a tingling sensation go from my head to my feet. At that point it started radiating in different areas. The lady next me was also having the same sensation. The nurses brought us both back behind the desk. They got my bp which was 158/88.  It was on the higher side. Then a third lady complained of the same sensation and also was taken back behind the desk. The tingling would not stop and was I was advised to walk around at that point. When I did that the tingling became much worse again. I was given an Allegra and started to feel pressure in my chest. Not pain just a weird sensation. They called a Code Blue on me. Which is what they do when you?re in the outpatient part of the hospital. I was placed on a simple oxygen mask and taken to the ER. When I arrived to the ER I was taken off the oxygen and placed on HR monitor lead and a pulse ox. Both the doctor that arrived first to my code and the ER doctor did a neuro assessment. They did an ekg on me which was normal, but was not done right away. The doctor came in to assess me again. At that time I was having more feeling on my left side. He sent me for a head CT which was read as normal.  I was observed and discharged at around 930pm. I do also have anxiety but what I was feeling was not right. I can?t describe but just a weird tingling all over. It would always get worse when ai would get up and walk. That did not stop until around 9pm. I was also concerned with the fact that two other people were having the same symptoms as me. I have not been to work for two days. I had awful pain in my arm,  I?ve had a horrible headache, nauseous, dry mouth, and I?m extremely fatigued.
Extreme itching little bumps everywhere including earm ear swollen loss of hearing . 2nd day still hurt. Hearing is fine still swollen
Blood in stool 4 days after vaccines, fussy. Seen in the ER, abdomina U/S ruled out intussusception. Stool cultures sent.
Patient came in to get his second dose of Moderna. After the inoculation, he was assigned to wait in the post-vaccination chair for 15minutes. After 5 minutes in, he began to feel dizzied, chill, sweaty, stomach pain, and wanting to vomit. He gave us permission to call 911 for him. We gave him a cold compressed to put around his neck while he waited for paramedic to arrived. They came and took his vital signs and asked couple questions. His vital signs were good and they discovered that he did not have lunch, he only had breakfast for the day. He felt a lot better after 20 minutes so he got released by the paramedic to go home.
they administered a booster dose (on 22Nov2021) early (2nd dose on 21Jun2021); This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they administered a booster dose (on 22Nov2021) early (2nd dose on 21Jun2021)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 005C21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they administered a booster dose (on 22Nov2021) early (2nd dose on 21Jun2021)). On 22-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they administered a booster dose (on 22Nov2021) early (2nd dose on 21Jun2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided. It was reported that booster dose was given early to the patient.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot # K010215, expiration date: 05-MAY-2017, route and dose were unknown) (incorrect product storage). The vaccine was excursion to -3.8 degree Centigrade for 113 hours. It was not excursion previously. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A 3 weeks and 3 days after the vaccine I woke up and noticed a swollen lymph gland in the groin area of my left leg. I took Cipro and after about 10 days it finally left. I'm not sure if it is vaccine related but because it did occur after the vaccine, I am reporting it.
Sick; fever; joint pain; Headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose Number Unknown, Single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sick, fever, joint pain, headache patient stated to know what if the second dose cannot be provided at 3 weeks when should I receive my second dose she stated that she didn't know the company of the vaccine received and didn't know the ingredients of the vaccine received and she stated to know the preservative of the vaccine and are there any components of the vaccine vial made of latex she stated to know and where was the vaccine manufactured and the emergency use authorisation can she receive other vaccines with the same time of this vaccination. Does this vaccine contain live virus and are covid-19 vaccines were interchangeable or not she had participated in the Pfizer- COVID-19 clinical trial she wanted to know can the patient get the vaccine if I had received a placebo. The outcome of the events illness, pyrexia, arthralgia, headache was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
I had the second shot at the same place on 2-11-21. At the time, I only had soreness of the left arm at the injection site and virtually no other symptoms except a mild headache for a few hours.  However, during the month or so between the vaccines and post-vaccine period, I developed pain in both shoulders with moderate-severe rotator cuff symptoms. This was pain in reaching in almost any direction. Also, I began to notice heaviness in both upper legs, front and back, which in a week or so progressed to tiredness and then to achiness, and finally to pain when I would squat, bend over, or get up from a chair. I have  never had either symptom before.
had history of  covid infection with side effects (more than those being reported at the time),  was told to get vaccine and started next morning with increased intensity: Shortness of breath, heart palpitations, increased migraines, reflux issues, weakness and neurological pain. Six months later, she still has lots of symptoms of asthma, chest pain, sharp pain and reflux.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at a dose of 1 UNK and VITAMINS NOS (DAILY VITAMINS) for Adverse event, at a dose of 1 UNK. On 20-Feb-2021, HEADACHE (headache) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant meidcations were reported.   This case was linked to MOD-2021-051632 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received on 09-MAY-2021 contains no new information
Information has been received from a physician via company representative referring to a 16 year old female patient. The information of concurrent conditions, medical history and concomitant medications was not provided. On an unspecified date in approximately February 2015 (about six months ago), the patient was vaccinated with the first dose of GARDASIL injection (lot#, dose, frequency and route were not provided). On an unspecified date in 2015 after receipt of the vaccine, the patient came for an office visit complaining of joint pain. The physician did not administer any further dose of the GARDASIL. The outcome of joint pain was unknown. Additional information has been requested.
About 1 hour after the shot, I started to have a bad headache. Around hour 5, fatigue and body aches set in. Around hour 12, chills, severe pain in my left arm and body aches and low grade fever. Could not move or touch my arm the pain was SO severe. This lasted for about 24 hours. About 2 hours after those symptoms subsided (hour 26 post vaccine), I was lying down on the floor and had fallen asleep putting my son to bed. I woke up and noticed my left arm was limp when I went to move it after waking up. I tried moving it and opening and closing my fist, but could not. I lost strength, mobility, and sensation. I then felt extremely nauseated and like I was going to pass out. I sat on the bathroom floor and put a cold compress on my head and neck, and noticed the same numb, loss of strength & sensation feeling spread to the entire left side of my body including my leg, mouth, throat and face. At this point, only about 20 minutes had passed since I noticed it. When the EMT arrived and tried to get me to stand up, I collapsed on my left side. They took me to the ER where they admitted me overnight for a full stroke workup. The continued to evaluate me but my symptoms started to subside about 2 hours after my arrival, and were gone by the next morning. The next day, my arm started to lose strength and sensation again for a few hours, then it subsided. Since then, I've had intermittent loss of sensation, mobility, and strength and my arm goes ice cold-- this is noticed whenever I am driving for longer than a few minutes. When I went to get the flu shot (in my RIGHT ARM) Sept 29, this triggered the same response in my LEFT arm where I was numb, could not make my hand do what I wanted it to do, could not grip, loss strength. This lasted a couple of hours and then subsided after about 5 hours.
Dose 2 received 9:50 a.m. on 2/19/2021. By 4:00 p.m. chills. By 7:00 a.m. 2/20/2021 chills, headache, nausea, vomiting, muscle aches, and dizziness.  The dizziness resulted in fainting and falling at approximately 9:00 a.m. Headache similar in intensity to migraine.
felt like pass out; he couldn't walk; difficulty hearing and breathing; difficulty hearing and breathing; worse symptoms; something is going on from the vaccine; A spontaneous report was received from a nurse concerning a 44-year-old, male patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced difficulty in walking(gait disturbances), felt like pass out( loss of consciousness), difficulty in hearing and breathing (hypoacusis and dyspnea), something is going on from the vaccine (vaccine complication), worse symptoms (condition aggravated).   The patient's medical history included psoriasis and arthritis. Relevant concomitant medications included duloxetine 60mg daily, baby aspirin daily, Tylenol as needed, beloxepin 50mg daily, vitamin c, turmeric 100mg, sildenafil, cortisone cream as needed.  On 25 Feb 2021, four days prior to the onset of events, the patient received  the second of two planned doses of mRNA-1273 (Batch number:012A21A)  intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Four days after the second dose, the patient experienced difficulty in walking.  He said something was going on from the vaccine.  He needed recourses regarding the medication he needed.  He went to his primary doctor and received a steroid injection.  After that, he felt like he was going to pass out, had difficulty in hearing and breathing, and worse symptoms.  His doctor suggested to immediately start with ustekinumab.  Treatment medication included a steroid medication and ustekinumab.  Action taken with mRNA-1273 in response to the event was not applicable.  Outcome of the events, difficulty in walking, felt like he was going to pass out, difficulty in hearing and breathing, vaccine complication and worse symptoms, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hi, my name is, I'm a RN and am submitting this report about my grandpa.  I took him into the VA to get his second covid vaccine on 2/17/21.   At that time my grandp lived semi-independently in a house between my parents and my uncle .  He didn't get out very much but with some help of grocery shopping and organizing his medication he was still able to live alone and function well independently.  My mother reported to me on 2/18/21 that my grandpa was confused, weak and tired.  My grandpa has never had any signs of dementia.  At this time he developed a delerium that waxed and waned.  He complained of headache, no appetite and extreme weakness.  On 2/23/21 he fell down in his house and we decided to move him into my uncles spare bedroom to keep better eyes on him.  The delerium persisted and on 3/5 he was taken to Hospital for a workup for his delerium and weakness.  There he saw Dr. an internal medicine doctor at hospital.  The workup showed an elevated BNP (probably baseline but I'd have to look at previous lab results) but nothing further.  We opted not to do further imaging and instead take him home.  It became obvious to me that this was the end of his life and so I requested a hospice referral from Dr. My grandpa died on 3/24/21.
inadvertently administered Pentacel to a 6 year old with no reported adverse event; Initial information received on 10-Jul-2023  regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 years old female patient who was inadvertently administered diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past vaccination(s) included DTP on 05-Aug-2017 and 26-Apr-2022 and IPV (2). The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (OKA/merck) (Proquad); and hepatitis A vaccine (Hepatitis A) for Prophylactic vaccination.  On 07-Jul-2023, the patient received 0.5 mL dose 3 of suspect diphtheria/ tetanus/ 5 hybrid ac pertussis/ IPV(vero)/ HIB (PRP/T) vaccine, suspension for injection (batch number: UJ805AA; Expiry date: 17-Feb-2024) via intramuscular route in the right deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered pentacel to a 6 year old with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initially, right after the vaccine, I had some sore arm and a little bit of chills - it was similar to what I had for my first dose of the COVID vaccine. Seven days later, I woke up feeling real light headed - like I might faint or pass out. I was having some chest pain as well. It sort of increased and I went to Emergency Medicine ER on 6/11 but they didn't find anything and they said everything was normal. After that, my chest pain is still there and my lightheadedness is still there from time to time but it not as often. I have some ibuprofen for the general pain to use for the chest pain if I need it. I still have the lightheadedness and general dizziness that is not fully gone. I have followed up with my primary care doctor. I am monitoring my blood pressure - it has been more or less normal now. It was high a few times before when the symptoms were more. Note: Three weeks prior to the Pfizer Covid Vaccine - Dose 1 (which was April 25th) I had a Tetanus shot (April 2nd - Medical Center - By injection left arm)
I had been caring for family that had tested positive for COVID-19. I had tried to keep my distance but ended up being positive myself. I thought I may have seasonal allergies but it was COVID-19. I a runny nose, congestion, a headache, a cough, I was not sleeping well due to caring for my granddaughter and my family. I have recovered from COVID-19. In late May about the 28th I started having lower back pain but blamed it to just being older and moving a ton. I then was not sleeping well and had my right foot go numb. I went to my doctor in early June and we did X-Ray's and there was a bulging disk in my back. I also have large gangrene cysts on that right foot that went numb, that has not gone away and I have followed up with a foot specialist. I have also seen a nerve specialist and there is not any nerve damage.