chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started experiencing dizziness and vertigo while driving around noon on Friday, April 16, 2021, to the point my hands were sweating and my feet felt pin pricks (akin to a flight/fight fear response, probably because I was so stressed trying to drive with the symptoms).  The symptoms subsided but returned in fuller force Wednesday, April 21, 2021, at 11am in the morning.  I am fearful now to drive which is a problem because my husband works out of state, my daughters are in college, I have to work and care for my 10 year old son.  Since the latest occurrence was just today, I have not seen a healthcare provider yet.
daughter who received the Pfizer vaccine and does breastfeeding; This is a spontaneous report from a non-contactable consumer (parent). A female patient (reporter's daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that she has a "daughter who received the pfizer vaccine and does breastfeeding". The consumer asked why was it that only below 12 years old could get vaccinated with Pfizer COVID-19 vaccine because she has a 4 years and 6 months old grandson that was in kinder and she was worried because her grandson could not take a vaccine yet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SIDE EFFECT TO ZOSTAVAX -- 12 HOURS, ABDOMINAL CRAMPING AND VOMITING TIMES 1 DAY.  HEADACHES TIME 2 DAYS. NO FEVER AND NO OTHER SYMPTOMS.
arm  soreness; Headache; This is a spontaneous report received from a contactable consumer (patient was a relative of reporter). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 10Feb2021 12:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination was reported. The patient's concomitant medications in two weeks before vaccination included ibuprofen, from unspecified. No other vaccines were administered in four weeks before vaccination. On 10Feb2021 13:30 the patient experienced headache and arm soreness. No treatment for events were received. Patient was not tested for COVID post vaccination. It was unknown if patient recovered. The outcome of the events was unknown.  Information about lot and batch number has been requested.
Pt was admitted to hospital with acute respiratory failure on 4/15/21  after receiving first dose of vaccine on 4/8/21. Per guidelines, all hospitalizations are reported
DYSPNEA WITH HYPOXIA, WEAKNESS, LOSS OF APPETITIE, FATIGUE  Narrative: Per nephr note 1/25/21: "got 1st covid vaccine on 1/21/21 and 'was doing okay afterwards until over the weekend. He's fallen 3 times, has run a low grade fever and his oxygen sat is down to 88%.' Brought to ED, per ED MD note 1/25/21: after 1st covid vaccine dose, 'has had generalized weakness of all extremities w/ falls w/o injury; previously ambulated w/ walker but now unable to do so & using wheelchair; since vaccine has had decreased appetite and PO intake, fatigue, constipation (last BM on day of vaccine/4 days earlier), persistent SOB." Admitted to hospital.
Patient received Fluad vaccine on Friday 8/28/20. On Saturday 8/29/20, she had a rash on her arm that she received vaccine in. On Sunday 8/30/20, the rash spread all over her body. She went to urgent care and got a steroid shot and a written prescription for oral steroids. Patient called our pharmacy on Monday 8/31/20 to notify pharmacist of reaction. Pharmacist added allergy to patient file and filled out VAERS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "severe neutropenia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive antigen tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 16Jan2023, Treatment stop date: 20Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
FEVER, CHILLS, SOB, RAPID HEART RATE; HOSPITAL ADMISSION 02/13/2020 TO PRESENT
Sore throat, which I only get when I am getting a cold.  Sore throat continued to 10/25. I started cold-eze lozengers several times a day. I fought Optical Migraines 10/26 & 10/27. Tylenol and Ibprofen as needed.  Hoarseness started evening 10/27 and worsened when awoke on 10/28.  I feel a little stuffy, but overall, sound worse than I fell.
pt recv vax 15JUL96 4PM;no problems slept good all noc till 6AM 16JUL96 t104.7 ax;went to ER immed APAP given;w/in 1 hr fever was down to nl-left ER;f/u same day felt fever was d/t shots but nl rxn;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 74.0. No concomitant medication was reported by reporter. Batch number 031L20A underwent temperature excursion on 17-Feb-2021 with temperature 20 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 17-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Mildly swollen red splotches/bumps on several fingers (and underside of left big toe). Only mildly itchy unless scratched - then they become extremely itchy with burning sensation. Skin issues still present, but discomfort relieved by antihistamine (generic Zyrtec). Ibuprofen/lotion/etc had no effect. I believe it was a delayed vaccine reaction because I?ve never needed antihistamines before in my entire life - no known ?true allergies? (just significant GI issues with eurythromycin, so I avoid it).
Pt. states that she noticed left arm redness, swelling on 1/18/21 at 8 am.
Initial misuse report received from a healthcare professional on 10 October 2013. The patient had received expired tetanus toxoid vaccine. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
headache dull after second vaccine; Cold sore, on the bottom of her lip, after second vaccine/Cold sore, upper lip, but larger, after second vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164) via an unspecified route of administration, administered in left arm on 23Apr2021(at the age of 62-years-old) as a 1st single dose for covid-19 immunisation. Patient had no medical history and concomitant medications. Patient did not administer any other vaccine prior to 4 weeks of vaccination. Patient did not administer any additional vaccines on same date of the pfizer suspect. Patient had no adverse reactions following prior vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8732) via intramuscular administered in upper left arm on 24Mar2021 around 14:00 (at the age of 62-year-old) as 1st single dose for covid-19 immunisation. Patient informed that side effects occurred after the second dose of vaccine on 23Apr2021. On 25Apr2021, patient experienced a cold sore on the bottom of lip that was for a couple of days. The patient noticed it probably when she got up in the morning and it didn't last for too long. The patient stated that she would get a cold sore, usually, about once a year. On past Monday, 03May2021, patient got a cold sore on her upper lip, but larger and she was on the path to healing and the cold sore has peaked. The patient works in a hospital, reclarified, and the nurses told her that she should, report her event. Patient also had a headache around noon time with this cold sore and she was taking medication. The headache as dull, and it was ongoing and patient took a couple of Motrin which was effective for her headache. Patient stated she usually gets a headache, when she gets a cold sore. Patient was taking a prescription medication for cold sore Cyclovir and it was shortening the length of time for healing and the cold sore was not lasting as long as it normally would, as when she doesn't take the medication. Patient thinks it was unusual that she got both cold sores after the second vaccine. The adverse event did not require emergency room or physician office visit. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Redness and hardness at injection site. No itching or pain. Approximately 2? in diameter.
Patient has arm soreness that is still continuing at present and is using a heating pad at times for relief.
lower back pain; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program COVAX US Support. A female patient (reporter's  mother) of an unspecified age received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) by an unspecified route of administration on 01Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lower back pain on an unspecified date on Mar2021 and the reporter wants to  know more about the side effects. The outcome of the event unknown.   Follow-up attempts completed. No further information expected.
Nurse accidentally gave a 16 year old patient a vaccination; A spontaneous report was received from a healthcare professional concerning a 16-year-old, male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and a nurse accidentally gave a 16-year-old patient a vaccination.   The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date of vaccination not provided) for prophylaxis of COVID-19 infection.   A healthcare provider called to report a nurse accidentally administered the vaccine to a 16-year-old patient. The patient has done well post vaccine without any issues.    Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, a nurse accidentally gave a 16-year-old patient a vaccination, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
5 minutes post injection felt like a wave washed over me. Heart started pounding, felt shaky, weak and dizzy, lips felt numb, felt clammy. Removed mask to increase breathing capacity.
HPI:  Patient is a 79-year-old female presenting to the emergency department for abnormal labs.  The patient was initially seen at an outside urgent care and referred here after they found that she had abnormal labs.  The patient is found have elevated creatinine.  She does have a history of Wegner's granulomatosis.  Patient states she has been feeling lightheaded had been falling frequently.  The patient fell this morning and sustained a laceration to her  right periorbital area.  Patient otherwise without new complaint.  EMS reports that she was hypotensive for them and gave small amount of IV fluid, improved her blood pressure.
Injection pain  within 1st hr ( actually had a zing in palm of my right hand when given shot);  some redness & swelling  about the size of a half dollar later in the evening, plus the site was hot.  about 25 hours later the swelling was the size of a baseball, with redness and site was hot. I did have a temp of 99.9,  temp taken about 30 hours after shot.  I took Tylenol and put an ice pack on it. I did have a headache, but wasn't sure if that was sinus/allergy or from this, still painful. Five days later most of swelling has gone done, but still red and warm to touch.
This spontaneous report as received from a nurse refers to an 11 years 3 months old female patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot #K004204, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
4/26/21          (Five) 25 y/o female with no medical history seen today complaining of dizziness and diaphoretic. Patient denies any allergy. Patient denies being pregnant. Per patient this is her first dose of the vaccine series. NP and paramedics at patient side. Vital sign obtained BP 136/87, bs 100, 98%, 18 RR, NSR on the monitor. Patient provided with a bottle of water and legs were elevated on a chair. Vital sign rechecked. 112/76, 79, 96% 18. Patient states she felt better. Patient discharge home.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. The pharmacist called about the administration of expired Moderna vaccine that were given as event or problem booster shot to patient around 490 to 500 people on the date last 20-Oct-2021 to 29-Nov-2021. The Lot Number of vaccines are as follows: 006C21A (10-Oct-2021) 026B21A (17-Sep-2021) 031 B21A (22-Sep-2021). It was reported that the vaccines was stored in freezer, they take out one to two vials and place in fridge each day as needed. No treatment given on the patients.
Sometime around Feb/March 2022 I noticed buzzing in my head. I attributed it to pressure on upper molars from an improperly-fit dental device that I started wearing on 12/29/21 for sleep apnea and have been trying to find a remedy ever since. I had the device properly adjusted in Feb 2022 but despite the relief of pressure, and subsequent treatments the chronic buzzing hasn't stopped. I've now become aware that it may be a result of COVID vaccinations and I hope a remedy can be identified. This was my 3rd COVID vaccine - the previous were Pfizer Biontech ER8730 on 3//25/21, Pfizer Biontech EW0161 on 4/15/21 at local pharmacy. Subsequent vaccines were Moderna 059M21A on 5/7/22 and Moderna Bivalent AS71L10C on 10/12/22 at Pharmacy.
I have swelling, redness, itching, and my arm is hot to touch. I have a rash from my injection site to up my arm. I noticed it yesterday and I went to the doctor. They told me it looks like a localized reaction and to take an antihistamine for a few days.
Patient received a Pfizer Bivalent 12y+ on 11/9/2022 and then received a second Pfizer Bivalent 12y+ today.  No adverse reactions noted. Patient notified.
Heart palpitations the evening of my injection and heart palpitations and chest pain the second day of my injection. Day 3 and after no symptoms
I developed Shingles on May 25th, 2021.  Not sure if related but Ive heard of several other people getting shingles recently. Feels relevant to report.
Sore throat turned into a head cold and cough.  Took over the counter medication but symptoms came back.  On 11/17 visited doctor who gave medication for wheezing, chronic bronchitis and hoarseness.  Began treatment with Azythromicin, Benzonate, Prednisone, Nasanex.  Days later general practitioner confirmed diagnosis.  1/9/07 visited doctor for recurring sore throat, wheezing in center of chest, prescribed antibiotic (cephalexin).
Systemic: Patient felt extremely tired soon after receiving her vaccination. I monitored patient for 40 min. and then called to check on her later that night and then again after the weekend as well. Patient was recovered when I called to check on her on 5/24/21.-Mild, Systemic: Hypertension-Mild, Additional Details: The patient's blood pressure was elevated during the monitoring period, but I am unsure of her baseline/normal blood pressure. I recommended the patient and her caregiver to follow up with her primary care provider to be evaluated for pediatric hypertension.
This spontaneous report as received from a physician  via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the first dose of VARIVAX (Merck) (route, lot number and expiration date not reported). There was no concomitant medication reported. The physician reproted that this was the last case occurred in approximately 2010 (about 2 to 3 years ago) of 5 cases that he/she had had "in the past ten years" (one patient for this report and 4 patiens for report MARRS # 1312USA005163), the patient experienced really, really mild chickenpox with low grade fever. On an unknown date the patient completely recovered from the adverse symptoms. This is one of two reports from the same source. Additional information is not expected.
We inadvertently administered the moderna vaccine past the 6 hours to a few clients of ours today; A spontaneous report was received from a nurse concerning two patients who were administered Moderna's COVID-19 vaccine inadvertently past the six hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an undisclosed date, prior to the onset of the event, the two patients received their first of the two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. The patients were inadvertently administered the Moderna vaccine past the six hour window; the healthcare providers thought that it was a new vial that had just been opened. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, inadvertently administered the Moderna vaccine past the 6 hours, was resolved.; Reporter's Comments: This report refers to a case of a patients of unknown gender who experienced non-serious event of was administered vaccine inadvertently past the six hours (out of specification product use) for mRNA-1273, (Lot # unknown, expiration date-unknown). There were no reported AEs associated with this case of vaccine inadvertently administered past the six hours.
Have loud ringing in my ears; This is a spontaneous report from a contactable consumer reported for self. This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EWO153) at single dose on 13Apr2021 11:30 in left shoulder for COVID-19 immunization. There was no medical history or concomitant medication or investigation assessment. Patient had loud ringing in his ears on 13Apr2021. It just happened 3 hours ago. There was no treatment received. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
experienced a Sore arm on previous date after receiving the First and second PFIZER COVID 19 Vaccine doses; This is a spontaneous report received from contactable reporters (Consumer and Physician). Other Case identifier: 01907850 (Merck).  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "experienced a Sore arm on previous date after receiving the First and second PFIZER COVID 19 Vaccine doses".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446577 Same reporter/drug/ event for different patients