chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took BP, was 85/65-stayed in that range for 2 hours- laid down.; extreme light-headedness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 14:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation.  Medical history included spontaneous coronary artery dissection (SCAD), migraines, irritable bowel syndrome (IBS) and non-ST segment elevation myocardial infarction (N-STEMI). Concomitant medications included apixaban (ELIQUIS), rosuvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and montelukast (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 15:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation.  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. It was reported that the patient was only on metoprolol as a preventive so as not have a second SCAD. The patient did not have hypertension and was on 50 mg two times a day. On 30Mar2021 at 18:45, after dinner, the patient had extreme light-headedness. The patient was not dehydrated and was not fasting. The patient's blood pressure (BP) was measured which stayed in the range 85/65 for 2 hours-laid down. The patient had never been hypotensive either. This happened 52 hours post second vaccine. On 31Mar2021 (reported as next day), she still felt moderately light headed, but BP was better, in 107/75 to113/85 range. The patient's body mass index (BMI) was 23.77 kg/m2. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event took BP, was 85/65-stayed in that range for 2 hours-laid down was resolving while that of extreme light-headedness was not resolved at the time of the report.    No follow-up attempts are needed. No further information is expected.
skipped second dose; skin felt sensitive; allergic reaction; rash all over her abdomen and  back; kind of like a low grade fever sensitivity feeling; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction), RASH (rash all over her abdomen and  back), PYREXIA (kind of like a low grade fever sensitivity feeling) and PRODUCT DOSE OMISSION ISSUE (skipped second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Asthma and Drug allergy (aspirin allergy). Concomitant products included MONTELUKAST, BUDESONIDE (PULMICORT FLEXHALER) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction), RASH (rash all over her abdomen and  back) and PYREXIA (kind of like a low grade fever sensitivity feeling). On 28-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (skipped second dose). On 04-Aug-2021, RASH (rash all over her abdomen and  back) had resolved. At the time of the report, SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction) and PYREXIA (kind of like a low grade fever sensitivity feeling) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (skipped second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was diagnosed with COVID-19 infection January 2021 that caused breathing difficulties. Patient is taking Rescue Inhaler No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up information includes no new information.
She was treated with a diagnosis of myocarditis in the post vaccination period. She felt ill post vaccination, mainly with GI upset. This worsened by day 6, she had syncope and brought to the hospital. Her troponin was elevated and she developed transient heart block. Coronary arteries were normal, hemodynamics were consistent with cardiogenic shock. LV EF decreased mildly. She responded to IV stress dose steroids. Endomyocardial biopsy showed lymphohistiocytic infiltrated and eosinophils.
This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
I struggle with seasonal allergies, and I thought that it was allergies. I had a runny nose, which I normally get from my sinuses. I had some nausea and vomiting as well. At the urgent care they swabbed me for flu and COVID-19. It came back positive for COVID-19. This was at Medical Group. The doctor told me that just because I'm fully vaccinated that I didn't need any medication for even the nausea and vomiting. The doctor told me that I wouldn't need Paxlovid. He told me to stay home for 3 days and wear a mask when I go out for the following 3 days. The very next day I called my Primary Care Physician, and she prescribed the necessary medications. She prescribed me Paxlovid and an Albuterol Inhaler. I believe I was asymptomatic. My house had just flooded and so I was having to live at various hotels while my house was being repaired.
have had GERD that I cannot get rid of, aggravated my GERD; have a hiatal hernia and do react to mediations that way; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (have had GERD that I cannot get rid of, aggravated my GERD) and HIATUS HERNIA (have a hiatal hernia and do react to mediations that way) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESYLATE and GLUCOSAMINE HYDROCHLORIDE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (have had GERD that I cannot get rid of, aggravated my GERD) and HIATUS HERNIA (have a hiatal hernia and do react to mediations that way). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (have had GERD that I cannot get rid of, aggravated my GERD) had not resolved and HIATUS HERNIA (have a hiatal hernia and do react to mediations that way) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: A follow up received on 19-JUL-2021 which contained Patient's demographics,  Concomitant medications.
pt recvd flu vax 15NOV93 & approx 1-2 wks p/vax pt broke out in herpes zoster;
Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Mild, Systemic: Other- wheezing, shortness of breath, coughing-Medium
pt recv vax & exp burning @ the inj site, rash on face & body & a loss of balance w/diff walking;
I had COVID-19 within a month before being vaccinated. I had a very mild case and did not believe I was sick until I tested positive. I felt fine after COVID-19 and returned to work. The vaccine was mandated and I did not want to loose my job so I took the 1st vaccine. Now, I am exhausted all the time, it's hard for me to concentrate, I have headaches every day and my left arm feels weird. I believe all this is from the vaccine because I was fine even after having COVID-19.
The patient was at 2 weeks and 5 weeks pregnant when she received the shots.  She went in for appointment in June and they did not hear a hearbeat.   She had a DNC procedure completed on 7/9/21
Local health center administered COVID-19 vaccine to patient when he was only 5 months and 4 days of age.
Pt started noticing little bumps (painful to touch / itchy-fluid filled-several), A LOT more on Friday 6/5/15...went to ER (MD didn't think it was chicken pox).
a 15 years old female patient received a dose of Flublok Quadrivalent vaccine/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA291168 and 2019SA291169 (same reporter).  This case involves a 15 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1910, expiry date: 26-Jun-2020, via intramuscular route in the left arm on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
I have an infected stye - that came the day after the shot.  It may likely have been caused by the shot - so my doc wanted me to report it.  It may also be a coincidence, but that is most unlikely.
Patient signed consent form and requested the first dose of the Pfizer Monovalent Vaccine and was given the Pfizer Bivalent Booster Covid Vaccine.  She was monitored for fifteen minutes after the injection as  per protocol and experienced no adverse reactions or symptoms.  Patient was notified on 9/29/22 that she received the wrong  type of vaccine and verbalized understanding. She is planning on returning for her second dose  of Pfizer monovalent on 10/22/22. Denies any symptoms or reactions beyond left arm discomfort. Educated in her native language by registered nurse to follow up with any questions or concerns.
acute encephalopaty; stroke/weakness on his left side/Altered mental status; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or around 16-JUN--2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient was admitted after suffering weakness on his left side, acute encephalopathy, altered mental status and he was ultimately diagnosed with a stroke. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product.  The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained serious, progressive, severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events stroke and encephalopathy were considered to be medically significant.
This spontaneous report was received from a pharmacist via company representative concerning a female patient in her early 60's (age). On an unknown date, the patient was vaccinated with ZOSTAVAX  (injection site unspecified) lot#J011339, expiry date: 13-DEC-2014. No concomitant therapy was reported. On an unknown date, the patient experienced redness and swelling, approximately 2.5 centimeters in diameter, at injection site. It was reported that, injection site reaction occurred 3 to 5 days after ZOSTAVAX was administered. No product quality complaint was filed. No intervention initiated to prevent serious criteria as there were none. The action taken was assessed as not applicable. The outcome of event was reported as recovered on an unknown date. The causality was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
RespDepression, Rash, paresthesia extremtiies (>24 hours post vaccine) Narrative: employee developed rash/hives 24 hours after vaccine; which progressed over time (initially arms, waist, then torso, face). She also began having shortness of breath. She took otc bendaryl day after vaccine but due to worsening of symptoms, she went to a community ER where she was treated with several doses of IV bendary, steroids, Pepcid, and zyrtec. Her symptoms have improved but she is still taking benadryl and steroid taper.
tinnitus that I got shortly after my Pfizer booster and it hasn't go away; I wanted it to go away, it is driving me crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: BNT162b2 (Dose:1, Lot no: EW0153), administration date: 06Apr2021, when the patient was 57-year-old, for Covid-19 Immunization; BNT162b2 (DOSE:2, Lot no: EW0168), administration date: 04May2021, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "tinnitus that I got shortly after my Pfizer booster and it hasn't go away"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "I wanted it to go away, it is driving me crazy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, emotional distress. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I took the 2nd dose of covin-19 pfizer on Sept 4, 2021. My menstrual period comes 2 weeks earlier than usual and lasts for 16 days. The blood volume is the same as the past, but spot lasts a longer time.
Mother states that clients right deltoid became swollen and red after receiving vaccines - no fever, no pain. Treated with ibuprofen and ice to area.
Redness upper arm (RT) 3" x 6", slightly swollen and warm to touch.
Chills, high fever, cellulitis around injection site. Pt went to hospital with high fever and weakness. Was given course of antibiotic upon release.
A report has been received from VAERS concerning a 5 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient received H1N1 nasal mist vaccine on 26-Oct-2009. On 05-Nov-2009, patient was hospitalized for 1 week history of fever, abdominal pain, diarrhea, and vomiting. Appendicitis was ruled out. Patient was discharged 07-Nov-2009. The same day 11-Nov-2009, patient developed purpuric rash with bloody stool, readmitted to hospital with presumed diagnosis of HSP (vasculitis). Discharged home 10-Nov-2009. Patient presented initially with abdominal pain, diarrhea, vomiting. Appendicitis ruled out by surgery and discharged home with presumptive diagnosis of HSP. Later developed purpuric rash on buttocks, thighs, ears, neck and feet bilaterally and grossly bloody stools. Readmitted, treated with prednisone which helped abdominal pain. Stools became negative for blood. KUB -unremarkable; CT of abdomen/ pelvic showed no signs of intussusception; Labs: LFT's (abnormal), CRP (abnormal), ESR, (abnormal), CBC with diff (Abnormal; Urinalysis (abnormal). The patient recovered from the event of the Henoch Schonlein purpura and liver function test abnormal on unspecified date. The reporter considered the events to be serious due to hospitalization.
sudden onset severe muscle stiffness and pain upper an lower extremities and severe L hip pain.  Proximal Muscle weakness noted.   Gradually resolving over next 5-6 weeks.   Pain did not respond to NSAIDS  Multiple doctor visits and physical therapy.   Possible diagnosis of acute onset Polymalgia rheutmatica  This has not been confirmed continuing to monitor and multiple physican visits scheduled.
First injection caused month long numbness in left shoulder. Took advil and tylenol that were recommended for my pain and reaction that did very little for month. Second injection caused immediate rash, then more numbness in left shoulder and then electric nerve vibrations from shoulder to wrist to this day another month later after second injection.
About 4-5 minutes after receiving my vaccine, my entire body got flush, and I almost passed out. I was able to stay conscious, but my sight became extremely blurry. I was not able to see well for the next 4 hours or so afterwards. I also developed a vertigo, and needed to take 2 days off of work, plus the entire weekend to begin to recover. The only thing that helped the headache, my eyes, and my head feel somewhat normal was to sleep. I slept on and off for most of the following 5 days after my vaccine.
Fatigue, chills, body aches, a body temp of 101.5 F,  beginning around 10pm on January 2nd, tested with Tylenol around 5am on January 3rd, fever resided for a few hours before coming back once more around noon on January 3rd, took more Tylenol and all symptoms have since not come back
Upon entering observation, pt sat down to book appt., pt started "belching".  Voices she felt "naseauated".  This nurse and other nurse's assisted Ee.  Cool compress was applied to forehead @ 1223.  EMS called @ 1225 r/t Ee condition worsening.  Ee  Left to ER via stretcher @ 1230.
Very Noticeable Decline in Blood Pressure; Tiredness; felt funky; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 26Mar2021 at 10:10 (Batch/Lot number was not reported) (at the age of 69 years old) as dose 2, single for COVID-19 immunisation in a hospital. Medical history included systolic hypertension from 2008 and ongoing (high blood pressure/ systolic hypertension); ongoing arrhythmia; ongoing blood thinner use. Concomitant medications included metoprolol taken for high blood pressure on 2015 and ongoing (for 5-6 years); amlodipine taken for high blood pressure and arrhythmia on 2019 and ongoing (for 2 years); apixaban (ELIQUIS) taken as blood thinner on 2019 and ongoing (for 2 years); flecainide taken for arrhythmia on 2019 and ongoing (for 2 years). The patient was previously administered the first dose of BNT162B2, via an unspecified route of administration, administered in right arm, on 05Mar2021 (Batch/Lot number was EN6206, however also reported as EL9265) (at the age of 69 years old) as dose 1, single for COVID-19 immunisation. The patient experienced very noticeable decline in blood pressure, tiredness and felt funky on 26Mar2021. Clinical course of events was as follow: On an early evening of 26Mar2021, the patient experienced a very noticeable decline in her blood pressure. It was 99/39 while on medications for high blood pressure which was an abnormally low reading. The patient waited for 15 minutes and felt fine but felt funky on her drive home but not terrible. The patient was tired after the second shot but didn't think anything of that and stated that it was spotty now, she was back to her normal cleaning and yard work, it has improved. Treatment included adjusted dose of blood pressure medications, reduced by half, then fourth and then none today; cetirizine for a couple of days and sipped electrolyte water. The patient spoke to an urgent care on a call last night (29Mar2021) because her blood pressure was 99/41 to ask if she should make a trip to emergency room due to low blood pressure. They told her to drink electrolyte water and if it further decrease, to go to general practitioner, but if it was staying stable, she was okay. The events did not lead to emergency room or physician office visit. The patient underwent lab tests and procedures which included very noticeable decline in blood pressure: 99/39 on 26Mar2021; 104/46 on 29Mar2021; 99/41 on 29Mar2021. The outcome of events very noticeable decline in blood pressure and tiredness was recovering; the event felt funky was unknown.  No follow-up attempts are possible. No further information is expected.
Burning with injection; tingling of lips within five minutes. Given 50 mg liquid diphenhydramine. Developed chest heaviness within several hours - called advice nurse/physician, was told to go to ED if symptoms worsened; symptoms abated, but woke next morning with headache.
This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 13-MAR-2017, the patient was vaccinated with improperly stored PNEUMOVAX 23, lot number as reported N000508, expiration date 19-OCT-2018, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature was from 9 to 25 Celsius degrees, in a time frame of 56 hours. The digital data logger was involved. No previous temperature excursion and no product quality complain was involved. No adverse effects were reported. Additional information has been requested.