chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Angioedema; Dysphonia; Dyspnoea; Swollen tongue; Throat tightness; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ANGIOEDEMA (Angioedema) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD, TIA, Migraine, PUD and Angioedema. Concurrent medical conditions included Diabetes mellitus and Hypertension.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 29-Mar-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), DYSPHONIA (Dysphonia), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency; EPINEPHRINE at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Angioedema), DYSPHONIA (Dysphonia), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per Authority reporting.  Events seriousness per IME list
Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination.
Redness on skin 1?below injection site. First occurrence was an oval roughly 1?x2?. Second was a circle roughly 1? radius. Both occurred 10 days after vaccine injection. Redness  resembled a bad sunburn on white skin. It was 99% cleared up at 12 days after vaccine injection.   No swelling or itching.
4/11/21 - Started having issues with dry heaving 4/14/21 - Started vomiting 4/15/21 - Went to urgent care due to vomiting was given zofran 5/15/21 - Chiropractic appt due to severe back pain and joint stiffness 5/25/21 - Went to primary care specialist; diagnosis - mast cell activation sydrome from vaccine; anti-inflammatory diet recommended plus some supplements; rapid weight loss due to inability to eat 6/10/21 - Returned to primary with worsening symptoms 6/15/21 - Returned to chiropractor due to worsening symptoms 6/29/21 - Went to another doctor for second opinion - due to worsening symptoms. 8/18/2021 - Primary care doctor - weight loss of 30lbs, continue treatment for nausea, stomach pains, headaches, body aches, fatigue, insomnia, bumbling of joints, muscle spasms Feb 2022 - Chiropractor - decompression of spinal vertibrae due to weight loss Aug 2021 - present , All symptoms that have been described above are still present.
pt recv vax & following a dose early in the series (one wk post exposure) pt exp severe abd cramps;
This is my second dose of Shingrix vaccine,  arm was swallen was so big, 10x 8 , and red and painful that kept me awake all night. I was have fever about 101.7 measure at home.  Weak and body was aching. Today is 2nd day and still icing the area. Yesterday went to urgent care, doctor said it was infection and proscribed me antibiotic, SMZ/TMP DS 800-160mg tab.
Swollen lymph gland in left armpit. This morning (one week later), it is red and itchy. Minor swelling.
While waiting in the post-vaccination observation area, patient reported feeling nauseous and briefly lost consciousness shortly thereafter. A Health Department Nurse caught the patient, safely lowered her to the ground, and raised the patient's legs. The patient quickly regained consciousness and was given a cold compress, water, and crackers while an ambulance was called. Her BP was taken as 118/85 approximately two minutes after the syncopal episode. The patient stood up briefly to then lay on the stretcher once the ambulance arrived, at which point the EMS performed their own evaluation. The patient was not transported to the hospital and was instead driven home by another individual. 8/20/21
2 weeks after receiving this 2nd dose tinnitus markedly increased in right ear. Audiogram was unchanged. Approximately  1 month later marked deterioration  in hearing  in right ear   diagnosed with Sudden Sensorineural  Hearing Loss. No return despite oral and intratympanic steroids. MRI wnl
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced a headache on an unspecified date. The patient reported she received a dose of Pfizer-BioNTech COVID-19 vaccine on Saturday and has had a headache since then. She wanted to know if this was normal, and if she can take anything to treat the headache (that seems to be a result of the Pfizer-BioNTech COVID-19 vaccine). She inquired whether any there were any contraindications with the fentanyl patch she uses. She wanted to know if she could use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. Outcome of the event: unknown. Follow-up attempts completed. No further information expected.
patient has a rash on her vaccine site, no fever, but sometimes itchy and not even hot upon palpation.
10 AM 7/13/2009- Seizure activity- fever 102.3 at OHI- at home- seizure lasted 3-4 min.  Mother brought baby to clinic 2:43 pm.  120mg acetaminophen administered by suppository 415 pm Rx for MOTRIN, TYLENOL given to mother-  follow up appt in AM.
Patient developed the flu after receiving the vaccine; This is a spontaneous case, initially received from other health professional via Agency (reference number: SEQ19-07478) on 16-Dec-2019, concerning a 7-year-old, female patient.   The patient had no relevant medical history.   The patient did not use any concomitant medications.  On 28-Nov-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 261204 and expiration date: 26-Feb-2020] for influenza prophylaxis.  On the same day, after vaccination, the patient developed flu.  On an unspecified date in 2019, the patient was seen by her paediatrician and was positive for strain B. Treatment medication Tamiflu (oseltamivir phosphate) was given for flu.   On an unspecified date, the patient recovered from the event of flu.  The event of flu was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Follow up was received by other health professional on 18-Feb-2020: It was reported that the patient had no medical history and took no other medications. The outcome for the event of flu' was amended from not recovered' to recovered'. Narrative was amended accordingly.  Company comment: The patient developed influenza, on the same day after Flucelvax Quadrivalent was administered. Chronology is plausible. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient developed influenza, on the same day after Flucelvax Quadrivalent was administered. Chronology is plausible. Based on provided information, causal role of the suspect product is assessed as related.
Severe body Aches, chills, fever , diarrhea , joint pain ; the body aches and fatigue lasted about 48 hrs , the fever about 2 hours, I took Tylenol.
PFIZER COVID VACCINE #3 GIVEN 10/12/21, LOT #FE3592; pt dx with COVID on 6/29/22 by PCP (Dr.) and was given Paxlovid; pt had worsening GI upset and was told to dc the medication; pt to ED on 6/30/22 with worsening weakness, malaise, frequent stools, poor po intake; O2 saturations in 80% on RA; O2 supplementation; Decadron and Remdesivir; dc'd Hospice in where she passed away
A week after getting vaccinated, I developed a red spot on the site of injection. Since then, my legs feel numbed with cramps.
Along with alot of extra bleeding; my menstrual periods have become more painful and my period was excruciating for a few days; my menstrual periods have become more painful/ booster did the same thing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 12:30 (Lot number: FJ1620) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Torn ACL", start date: 2017 (unspecified if ongoing); "Penicillin" (unspecified if ongoing). If other vaccine in four weeks was no and other medications in two weeks was none. If covid prior vaccination was no and if covid tested post vaccination was no.The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 18May2021, for COVID-19 immunization, reaction(s): "Ever since I received the second shot, my menstrual periods have become more painful."; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 27Apr2021, for Covid-19 immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset 19Nov2021 12:00, outcome "recovering", described as "Along with alot of extra bleeding"; IMMUNISATION (medically significant) with onset 18Nov2021 12:30, outcome "recovering", described as "my menstrual periods have become more painful/ booster did the same thing"; DYSMENORRHOEA (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "my menstrual periods have become more painful and my period was excruciating for a few days". Therapeutic measures were not taken as a result of haemorrhage, immunisation, dysmenorrhoea.
02/05/22 presents to ED for " Abnormal Imaging" "Chest pressure". PMHx of "Acid reflux, Hyperlipidemia"
Patient given Anthrax #9 vaccination out of cycle--due in Jan 2014, given Oct 18 2013.
Patient's daughter reported a fever of 102  at 12:00 (measured at patient's home). She stated he woke up at 7 a.m. with chills and was given 1000mg acetaminophen right after. She gave him another 1000mg acetaminophen at 11:45.
bad rashes on different portions of his body/ Rash on arms, shoulders, and neck after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (bad rashes on different portions of his body/ Rash on arms, shoulders, and neck after getting the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (bad rashes on different portions of his body/ Rash on arms, shoulders, and neck after getting the vaccine). At the time of the report, RASH (bad rashes on different portions of his body/ Rash on arms, shoulders, and neck after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatments were reported.
tbe patient did not seroconvert for measles or hepatitis B, and had low varicella titers; tbe patient did not seroconvert for measles or hepatitis B, and had low varicella titers; the patient did not seroconvert for measles or hepatitis B, and had low varicella titers; This spontaneous report has been received from a nurse practitioner via a company representative reporting on a female patient around 21-year-old. The patient had no pertinent medical history. The patient's concurrent conditions and drug reactions/ allergies were not unknown by the reporter.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) diluted with sterile diluend, Hepatitis B Vaccine (Recombinant) (manufacturer unknown), and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (doses, routes of administration, lot numbers and expiration dates were not reported).  On an unknown date, the patient had her titers done; the patient's titers showed that the patient did not seroconvert for measles or hepatitis B, and had low varicella titers. It was unknown if treatment was given to the patient due to the adverse events.  It was unknown the present status of the patient by the reporter. The causal relationship between the events and the suspect therapies were not reported.
Developed knots in both thighs 3-4 hours after vaccines were given. Has swelling and erythema and tenderness in both thighs.
Let me preface by saying I don't know if this happened BECAUSE of the vaccine. I'm super pro-vaccines and am not quick to jump to conclusions about adverse reactions to them. Both times I got the Moderna covid vaccine, about 10-15 days later (roughly - unfortunately I didn't write down the dates)  I had events of chest pain and fluctuating and sometimes extremely rapid heartbeat. It bears mentioning that I don't have a history of these symptoms. The first time, I actually thought I was having a heart attack or something and got a troponin test the next day, and got an EKG at a doctor who didn't find anything wrong. Those 2 times it happened are the only times it's happened to me.  Bears mentioning that it DIDN'T happen when I got the Pfizer as my booster.
I had an auto-immune flare up starting the day after the vaccine. I took care of myself. Then over the course of the next couple of weeks. I had on and off headaches. My thyroid then in April 2021 - it swelled (I had another auto-immune flare up). My neck gets really thick feeling and kind of swollen. In May, on and off, I had symptoms of my legs falling asleep more often. My vision has gotten worse in the last three months. It is a little more blurry. I had a lot of breast tenderness happen. I went for a mammogram. My anxiety and depression is off the charts and I'm able to manage things pretty well usually. I talked to someone this morning and a therapist, too. Thinking what to do given insurance.  I had been discounting the symptoms because I was not thinking it was vaccine. It has increased a lot in the last three months, though, all the doctoring and symptoms I have had. I've felt out of whack; exhausted a lot and have put on a lot of weight. It's still all happening.
Bell's Palsy right side of face; This is a spontaneous report from a contactable physician and consumer. An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via intramuscular first dose on 12Jan2021 14.00 at a single dose for COVID-19 immunisation. The patient medical history included DM (diabetes mellitus), hypertension, CAD (Coronary artery disease) and Atrial Fib (Atrial fibrillation). The patient concomitant medication was not reported. The patient visited physician office and it was reported that patient experienced bell's palsy right side of face on 27Jan2021 06.00. The patient did not receive therapeutic measures for the event. The patient did not have COVID prior vaccination and not tested COVID post vaccination. The patient had not received any vaccine in four weeks (as reported). The outcome of the event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNt162B2 on reported event cannot be excluded.  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.
Hives on the inside of both arms for 3-4 days Hives on the inside of both knees for3-4 days Itching near my eyes, on arms, back and legs continual since the first shot.   Itching is getting less and less and off and on.
Jaw -> eye numbness *Sx's gone @ 2pm L arm numbness/tingling in fingertips tongue- numbness.  Going away after 20 min of report.
Information has been received from a nurse practitioner concerning a 21 year old female. On 22-JUL-2008, she was vaccinated with a first dose of GARDASIL IM into the right deltoid. On 06-OCT-2008, she was vaccinated with a second dose of GARDASIL vaccine IM into the right deltoid. In the morning of 07-OCT-2008, the patient went to urgent care center with complaints of fever, nausea, and vomiting. The patient's temperature was 100.6 F as taken by tympanic thermometer. she was given a strep throat test, with negative result. The patient was released form urgent care center. Treatment was over the counter TYLENOL or Ibuprofen as needed. She had follow up appointment with nurse practitioner. The patient's fever, nausea, and vomiting persisted. Additional information has been requested.
Fever 99.9. Severe muscle pain. Bad Headache. Dizziness. Nauseous. Neck pain.
48 hours after receiving H1N1 #2 developed pain, redness and stiffness hands and feet, face flushed. No difficulty breathing. Pt developed lines on face next day (1/18/2010). Mom gave BENADRYL, rash improved. No further problem.
This spontaneous report as received from an administrator via a company representative refers to a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1, 1 injection, intramuscular (lot # was not reported) for prevention of HPV and on the same day and in the same arm (reporter did not specify if it was right or left) the patient was vaccinated with MENACTRA (dose and lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced swelling after being administered both GARDASIL and MENACTRA. The patient's mother took the patient to the emergency room for observation. The patient sought medical attention. The outcome of swelling was reported as recovered on an unknown date. Causality was not reported. Additional information has been requested.
6.5cm x 8cm swollen area, painful - hard knot under skin; warm to touch. C/O general malaise, temp of 98 degrees, oral. Was feeling some better, less achy by Friday PM.
This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 03-FEB-2015, the patient was vaccinated with improperly stored oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016. No adverse events were reported. No product quality complaint (PQC) was reported for oral, ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Received diluent without reconstitution; Received diluent without reconstitution; This case was reported by a other health professional via a representative and described the occurrence of inappropriate preparation of medication in a 19-year-old female patient who received ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as the age at vaccination was not reported. The patient had received the Menveo diluent without reconstitution with the lyophilized powder, which led to inappropriate preparation of medication, and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with US2021178412, reported by the same reporter. Sender's Comments:  US-GLAXOSMITHKLINE-US2021178412, Same reporter.