chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling on her right eye; This is a spontaneous report from a contactable consumer(spouse). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0173; Expiration date was not reported), via unspecified route of administration in the left arm on 11May2021 17:30 (at the age of 38-years-old) as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0162; Expiration date was not reported), via unspecified route of administration in the left arm on 20Apr2021 05:00PM (at the age of 38-years-old) as first dose, single dose for COVID-19 immunisation. On 13May2021 at night, the patient experienced the swelling on the right eye. The outcome of the event was not recovered. The reporter wanted to understand if any action needs to be taken and asked if this was normal and expected and how to go about it.  No follow-up attempts are possible. No further information is expected.
After I got the shot my lymph nodes under my arm swelled up to the size of a gold ball and it felt like I was being stabbed with an icepick. I also devolved a really bad headache. Both lasted about four days . I took Ibuprofen over the four days. It ended up going away fully after a week.
nausea Narrative: 52 yo male with unknown PMH was observed to have dizziness and nausea during the post observation period after his first dose of covid19 vaccine. Patient reported feeling 6/10 dizziness 3/10 dizziness following first dose of Covid-19 vaccine. BS 266, BP 140/93, HR 76, Temp 98.2 and 98% O2. Denied anxiety, chest pain and shortness of breath. Upon drinking water and sitting for an additional 15 minutes, Patient reported resolved nausea and dizziness. He was ambulatory upon leaving the Covid-19 vaccine clinic. Vaccine was administered without complications.
No other AE/PQC reported; temperature excursion on ROT ATEQ and states one dose has been administered; This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAR-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1742458, expiration date 22-JAN-2022 (strength, formulation, route of administration and dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 34.2 Fahrenheit degrees (F) for 8 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
both legs swollen @ inj site;fever of 104 large red bumps all over the body-started 3 days p/vax; 2 ER visits 3rd & 5th day p/vax;DPH in ER APAP/DPH rx for fever-rash;
area of redness approx 1 1/2" in diameter @ site of inj;area warm to touch;no puss;large 2" in diameter;used ice to cool down;
irregular periods: after having the COVID19 vaccine, she read about this happening to other women, vet reports having 2 weeks of vaginal bleeding, despite having the Nuvaring in, she reports having a normal period 3 weeks ago, but had started bleeding again and not normal spotting but having  what she describes as a full period. Vet reports she had always had random spotting between periods, that was light and not every cycle. Vet reports that she would sometimes keep the nuvaring in for 4 weeks to skip periods, sometimes. She was advised she May replace immediately with new ring after 21 days, to skip period for up to 3-4 months at a time, but she will have increased spotting risk when attempting to skip periods. Vet wants to continue the Nuva ring. Vet agrees to vaginal ultrasound and will report any problems with ongoing bleeding, or if she had pain, so that gyn referral could be placed.
Headache then nausea then went to the hospital due to shortness of breathe and doctor told her it was due to the vaccine
1 1/2 hrs. after vaccine given pt. reported severe flu symptoms. He was very ill, weak, pale, & faint. He went to ER following morning MD wanted to keep him overnight but he declined.
Body aches; Sore; Low energy; Woke up at midnight with severe chills; Fever; Swollen lymph nodes under left arm; shivered for two hours; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737 19606) via an unspecified route of administration in the left arm on 06Apr2021 at 09:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medications included mesalazine (LIALDA) for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208 19678) via an unspecified route of administration in the left arm on 16Mar2021 at 17:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 00:00, the patient woke up at midnight with severe chills, fever shivered for two hours, had body aches, low energy, was sore and had swollen lymph nodes under left arm. The patient did not receive treatment for the reported events. The clinical outcome of events severe chills, fever shivered for two hours, body aches, low energy, sore and swollen lymph nodes under left arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated event "shivering" and updated Lot Number.
Information has been received from a medical assistant concerning a 76 year old female consumer with coronary artery disease, hypertension, hypercholesterolemia, gastrooesophageal reflux disease, osteoporosis, sulfonamide and codeine allergies and an autoimmune disorder and a history of cerebrovascular accident who on 03-DEC-2007 was vaccinated SQ with a first dose of ZOSTAVAX (Oka/Merck). It was reported the patient had a rash at the shoulder area prior to vaccination. Concomitant therapy included TOPROL XL TABLETS, PROTONIX, aspirin, COUMADIN, multiple vitamins, PRAVACHOL, alendronate sodium (MSD), ASTELIN, enalapril maleate (MSD), "dil" and "omacor." Subsequently, on approximately 04-DEC-2007 the patient's rash progressed to all over her body since vaccination. The rash was biopsied and found to be caused by an autoimmune disease (unknown type) and needed to be treated. It was suspected that the vaccination exacerbated her conditions. On 28-DEC-2007 the patient was hospitalized for cardiac arrest, increased INR, and looked like she had sepsis and shock. This was due to electrolyte abnormalities. The patient experienced ventricular tachycardia and went into cardiac arrest. A defibrillator was implanted into her. On 02-JAN-2008 the patient was hospitalized again. According to the "cath report," the patient was admitted for "severe native 2 vessel disease with occluded OM2 and LAD." The patient also experienced severe pulmonary hypertension. It was also reported that early in April 2007 the patient reported malaise and not feeling well. On 16-APR-2008 the patient developed swelling all over her body, physical impairment from the rash and no desire to get up move around. At the time of the report the patient had not recovered. Her cardiovascular condition was reported as stable. There was no product quality complaint involved. The reporter considered the events to be disabling, life threatening, and other important medical events. Additional information has been requested.
November 22, 2021 I went for my second dose of Moderna. Instead of receiving the second dose I received the booster shot. Dr. insisted for me to get another booster for the equivalence of the second dose I was supposed to received. I am incredibly out of words for the negligence that was provided. It seemed like they were ready to wrap up for the day and just wanted to leave for the night. Now I am full of concerns and Dr. was not able to answer.
pt devel t104-105 R; 8PM 22NOV temp would be down to 101-102 R in AM then raise again to 104-105 in PM x 3 days; Pt seen by MD 25NOV fever 100 R; dx rt otitis media, pharyngitis & questionable MMR rxn;
From golfing on 02/23/2021 to dimentia suddenly going into overdrive and death on 03/31/2021 All tests and care was taken to  understand rapid/ unexplained decline.
Pt developed fatigue, lightheadedness, and painful swelling in R axilla 4-5 days after vaccine administration in R upper arm. Pt seen today in clinic w/ same complaints. Says symptoms have been stable over last 2-3 days. Denies LOC, HA, f/c, SOB, chest pain, n/v.
pt recv vax 1NOV97 & 3NOV97 pt exp phlegm, coughing, vomiting & diarrhea;5NOV97 pt recovered from diarrhea;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Heavy mid cycle menstrual bleeding leading to an Acute promyelocytic leukemia (APL) diagnosis on August 6, 2021
Loss of taste within 5 hours.  Other adverse events listed in common list including fatigue, low grade fever, arm pain, muscle pain, bone pain
pt recvd vax;30 min after shot started high pitched screaming;lasted at least 3 hrs; t 102;called PMD who said there was nothing they could do to put heat on it;leg swollen for the rest of the day;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender, with no pertinent medical history reported. On 23-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The pharmacist reported that on an unknown date the patient developed a red rash on the opposite side of the body from where the injection site of ZOSTAVAX was. The red rash was reported to be on the patient's chest and opposite arm that did not receive ZOSTAVAX. It was not reported how the rash did look like. The pharmacist reported that the patient went to an unknown physician who prescribed "some type of hydrocortisone cream (not specified)". The patient also reported this event to the unknown pharmacy were the ZOSTAVAX was administered. The outcome of the red rash was unknown at the time of the report. The reporting pharmacist did not assess the causality between red rash and ZOSTAVAX. Additional information has been requested.
Pt developed generalized pruritic, without hives, sensation of throat closing, swelling, chest pain, SOB or abdominal pain, pruritis intensity rated as 3-4/10. Heart + lungs, clear to auscultation, no facial/lip tongue/oropharyngeal swelling, no hives Pt was given benadryl 25 mg capsule Symptoms resolved within a few minutes of taking benadryl She was advised not to drive herself home
symptoms of numbness in lips and face; feels weird; numbness in lips and face 40 mins after the first dose; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (numbness in lips and face 40 mins after the first dose), HYPOAESTHESIA (symptoms of numbness in lips and face) and FEELING ABNORMAL (feels weird) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (numbness in lips and face 40 mins after the first dose) and FEELING ABNORMAL (feels weird). On an unknown date, the patient experienced HYPOAESTHESIA (symptoms of numbness in lips and face). At the time of the report, HYPOAESTHESIA ORAL (numbness in lips and face 40 mins after the first dose), HYPOAESTHESIA (symptoms of numbness in lips and face) and FEELING ABNORMAL (feels weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter. No concomitant medications reported by investigator
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 08-DEC-2015, the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL (lot # K011562, expiration date 08-APR-2017) (strength, route of administration and anatomical location were not reported). There was no concomitant medication reported. The reporter stated that the GARDASIL vaccines, were exposed at 32 degrees F (also reported as 31 degrees F) during 2 hours 30 minutes. No adverse effect was reported and no product quality complain was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa), Drug allergy (Cefdinir), Blood pressure high and Acid reflux (esophageal).Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 2002 to an unknown date for Acid reflux (esophageal), LISINOPRIL from 2017 to an unknown date for Blood pressure high, CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) from 2015 to an unknown date for an unknown indication. On 14-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 12-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021 at 1:00 PM, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 14-Feb-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache) had resolved.Concomitant medication include vitamin supplement.Headache (normal) and a sore arm (that resolved)within one or two days Patient took bed rest. This case was linked to MOD-2021-378122, MOD-2021-378089 (Patient Link). Most recent FOLLOW-UP information incorporated above includes:On 11-Nov-2021: Additional information includes Patient demographics,Medical History,Event Recovered date added 14-Feb-2021.
Received Varicella vaccine on 11/19/2002. Presented on 4/29/04 with varicella in office. Still erupted.
Fatigue, mild headache most of afternoon on 3/10 then towards evening a wave of nausea followed by shortness of breath accompanied by mild chest pain that lasted several hours.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of RECOMBIVAX HB lot numbers reported as M042322, N002913, N002202 and L038499; with expiration date of 21-FEB-2019, 23-FEB-2019, 04-NOV-2019 and 26-JUN-2017 respectively (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature excursion of 47 Fahrenheit (F) to 77 Fahrenheit (F) during 10 hours and 12 minutes. There were no previous temperature excursions. The call was because of a "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010669:
I'm not even sure if it related to the vaccine. I'm trying to figure this out. Large red welts buttocks and back torso area. extremely tired. lasted approx. 1hr. noted same on feet. few on legs. gave benadryl, but seemed to be fading prior to dose. next day in school noticed red raised "welts" on fingers. also went away. not sure if this is something to be concerned about, esp. since vaccine was the only most recent change. menses was 21days not 28.
Patient experienced localized swelling from the site of injection to the elbow. She is using cool compress and was suggested an NSAID such as Ibuprofen or ALEVE. She is to follow up with her physician if symptom does not improve.
Atrial fibrillation; heart converted to regular sinus rhythm; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and THERAPEUTIC RESPONSE UNEXPECTED (heart converted to regular sinus rhythm). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and THERAPEUTIC RESPONSE UNEXPECTED (heart converted to regular sinus rhythm) outcome was unknown.            It was reported that patient  experienced events after 20 years of having atrial fibrillation.  No concomitant medication information was reported.  No treatment medication information was reported  This case concerns a male patient of an unknown age with relevant medical history of Atrial Fibrillation, who experienced the unexpected serious adverse event of special interest, Atrial Fibrillation. The event occurred on an unknown interval after receiving the third dose of mRNA-1273 Vaccine. The rechallenge is not applicable since no information about the second dose was given. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of an unknown age with relevant medical history of Atrial Fibrillation, who experienced the unexpected serious adverse event of special interest, Atrial Fibrillation. The event occurred on an unknown interval after receiving the third dose of mRNA-1273 Vaccine. The rechallenge is not applicable since no information about the second dose was given. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
RECEIVED PFIZER MONOVALENT INSTEAD OF BIVALENT FOR THE 4TH DOSE
Patient said arm was sore and then they were shaky and weak for approximately 12-15 hours.
This spontaneous report was received from a registered nurse via medical assistant and refers to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666; US-009507513-1710USA014650: Original Case: 1710USA014649; US-009507513-1710USA014651: Original Case: 1710USA014649; US-009507513-1710USA014649: Original Case: 1710USA014649.
Developed double vision. Confirmed by opthomologist following day. Follow up 5 days later demonstrated reduction in side effect but significant degree of double vision persists today.
pt recv vax 5JUN98 & 9JUN98 pt recv fever spike that MD described as being quite high & greater than 40C (exact temp unk);same of of vax lab work done & pt dx w/acute lymphocytic leukemia;