chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported.; patient was administered MMRII [T033814 10/5/2022] and PROQUAD [U026794 2/26/2023], instead of MMRII and VARIVAX.; patient was administered MMRII [T033814 10/5/2022] and PROQUAD [U026794 2/26/2023], instead of MMRII and VARIVAX.; This spontaneous report was received from a medical assistant and refers to an 18-month-old female patient. Her medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot number U026794, expiration date: 26-FEB-2023 (dose, strength, and route of administration were not provided), and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot number T033814, expiration date: 05-OCT-2022 (dose, strength, and route of administration were not provided) both administered for prophylaxis (overdose); instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, strength, lot number, expiration date, and route of administration were not provided) (wrong product administered). No additional adverse event was reported (no adverse event).
Began with feeling "flush", followed by headache, fever 100.6, shakes, malaise, nausea. No local reaction.
Information has been received from a physician concerning a 69 year old female who on 23-JAN-2007 was vaccinated with a dose of Varivax instead of a dose of Zostavax. The physician stated that the error occurred because the individual who gave the vaccine knew it was the varicella strain and she knew that Varivax was varicella and forgot about the Zostavax that was new to their practice. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
door was left open/vaccines were being organized Max temperature reached: 9°C. Duration out of labelled range: 9 minutes 1st excursion: 26 minutes with no Adverse event; ipolwas administered to patient after excursion with no reported adverse event; Initial information received on 09-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom ipol was administered after excursion with no reported adverse event and door was left open/vaccines were being organized Max temperature reached: 9°C. Duration out of labelled range: 9 minutes 1st excursion: 26 minutes with no Adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the suspect IPV (VERO), Suspension for injection via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number and expiry date: unknown) ipol was administered to patient after excursion with no reported adverse (Poor quality vaccine administered) (latency same day). Information on the batch number was requested  On an unknown date door was left open/vaccines were being organized Max temperature reached: 9°C. Duration out of labelled range: 9 minutes 1st excursion: 26 minutes with no Adverse event (product storage error) (unknown latency).  Reportedly, extended stability data cover the excursion- No Administered to a patient- Yes Previous excursion: Yes  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events product storage error and poor quality vaccine administered  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
08/10/23 Received varicella vaccine - felt run down just finished summer program  08/11/23 symptoms:   shortness of breath, tightening of chest (wakening during the night gasping), instense hot flashes - mostly when eating food, light headed and dizzy, little tighening of throat, numbness in lips. Symptoms worsening over time.   Lightheadedness and weakness most debilitating.    08/15/23 - due to symptoms, took a covid test and it was negative.   08/17/23 went to the ER  after throat was more uncomfortable than it has been.   EKG & CXR done.  Blood work done.  No IV.  No meds administered.  Was advised to contact clinic to report VAERS and also not to get the 2nd dose.  He will need a note from a doctor to excuse him from the 2nd dose of varicella.   Right now, feeling better mentally -odds are symptoms will taper off.   In general, haven't eaten anything today.  Feels light headed/dizzy/weak.  Short of breath (more localized in chest).  Throat - still swollen, red.   08/17/23 - seen by MD who recommended that he not receive 2nd dose of varicella and to report the adverse reactions.
OCCURRING 1 DAY AFTER FLU VACCINE. LEUKOCYTOCLASTIC VASCULITIS/ URTICARIAL VASCULITIS. PURPLE BLOOD SPOTS ON EXTREMITIS. TREATMENT - PREDNISONE, TOPICAL STEROID CREAM. PRESENT ON SKIN FOR OVER 2 MONTHS.
On February 2nd I started experiencing tingling and twitching in my arm and face. On the 3rd I developed shingle blisters on the left side of my abdomen. A week later I had the burning sensation of shingles all over my body. I continue to have weakness in my right arm and leg, tingling in my right hand and sparkling floaters in my vision. I have had a MRI of my brain. They identified telangiectasia on my pons and they also found a legion on my left frontal temporal lobe. My neurologist ordered a MRI of my neck which came back clear. On July 6th I had a lumbar Cap analysis my spinal fluid and on July 12th I had to have a blood patch because I had a spinal fluid leak.
I received my second dose of the Moderna COVID-19 vaccine on 4/5/2021 in the early afternoon. After getting the shot, I went directly home and took care of an errand. After the errand was done, I went straight to bed, because I felt extremely tired and my joints started feeling sore. At around 10 PM, I woke up from my sleep drenched in sweat. All of the muscles in my body began to feel tired and achy. I just felt uncomfortable from head to toe. I had a fever that bounced between 101 and 103. I also experienced a loss of appetite. I just basically felt like I had a bad case of the flu, minus any coughing or sneezing. I just stayed in bed for 3 days, and the only time I ever got up was to go to the bathroom and maybe get a drink of water. It wasn't until the third day afterwards that I felt well enough to get out of bed and return to normal life. For the following 2 weeks afterwards, I had a severe headache and the area around the injection site was really sore, swollen, and red. I took Excedrin every day for 2 weeks to treat the headache, and although it did not completely get rid of the headache, it did take the edge off of it and make it more manageable.
Injection site red for 6x3 inches surrounding injection site, warm to touch, not tender, knot at injection site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, 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: started it the day after I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient had a bitter metallic taste in mouth while taking the medication. Other than that it worked very well. The patient started it the day after  tested positive and got better very quickly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative: COVID infection following COVID vaccine series 03/16, Pfizer, DOSE #1 04/06, Pfizer, dose #2 09/20 pt cc: chills, cough, fatigue, diarrhea, fever, headache, myalgias, rhinorrhea, congestion, sore thorat, exposure: unknown 09/21 COVID swab, result: detected 09/21 SARS-COV Variant Sequencing result: pending 09/23 COVID swab, result: detected clinically resolved
Fever-102.7 9/13/02, 101.7 9/14/02. Irritable, no rashes.
This patient was under the recommended to age to receive the Covid-19 Vaccine on the vaccination date of 1/8/2022.  The child was 3 years old.  I was advised RN  to complete a report on the VAERS system.   This particular vaccination clinic was off site at the local public high school.  The person who vaccinated this child was a Public School Nurse.  The Health Division has not received any notification of this child having any medical problems to date.
On 10/31/2011 patient received INFLUENZA vaccine and pneumococcal vaccine. Patient still c/o arm pain on 2/23/2012 .
Pt developed a fever of 105 after vax. Fever lasted 12 hours.
CLENCHING JAW 9 DAYS AFTER GETTING THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced clenching jaw 9 days after getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clenching jaw 9 days after getting the vaccine. This report was non-serious. This case, from the same reporter is linked to 20221211987.
Patient received her first ever dose of Depo-Provera in her left deltoid IM and Moderna Bivalent IM in right deltoid about 1530. Patient's mother who was accompanying patient to office visit called into provider's office at 1555 stating that patient was red, short of breath, unable to form a coherent sentence in car. Mother was instructed to take patient to nearest hospital right away. We contacted local hospital to let them know that patient  was coming and her medical history. Contacted mother at 1620 and patient was able to be seen in the hospital right away.
Sneezed - flushed (skin) fare without acute distress - without SOB: 5ml BENADRYL per protocol. Referred to MD - Primary Ped.
After the Covid-19 Vaccine on Mar 26, 2021 I had an adverse reaction to something that may or may not be related.  On Friday, Apr 2, at 2:00pm I felt a weird case of Vertigo that lasted approximately 3 mins.  The next day, Sat. Apr 3, at around 9:30pm I had a longer very severe case of the vertigo.  I went to bed shortly afterwards.  On Sunday,Easter morning April 4, at 6:30am I woke up with a very severe case of vertigo (Meniere's Disease).  It lasted about 3 hours of sever heaving and extreme dizziness.  I could not cope and had to just lay there not knowing what was wrong/going on.  It finally went away after about 3 hours.  The next morning, Mon. Apr 5, I called my Dr  to make an appointment and went in 2 days later.  There were no other cases of it and he could not figure what caused it and I either could I.  So far so good that I have not had another reaction and feel fine today after nearly 3 weeks.  :-)
Hives; Rash on my chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Rash on my chest) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Hydroxizine PRN and Xolair- 1 injection monthly for an unknown indication.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced URTICARIA (Hives) and RASH (Rash on my chest). The patient was treated with HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) ongoing since an unknown date at a dose of 1 UNK. At the time of the report, URTICARIA (Hives) and RASH (Rash on my chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were not applicable.
Pt reported 12/07/2001 a day after receiving the TD vaccine she notice itching at the injection site with redness and swelling. On 12/20/2001 she reported it was warm to touch. She plans to go to ER.
At seven hours developed moderate chills and shaking and teeth-chattering lasting 3 hours with complete recovery.  Myalgias starting at 5 hours and persisting into 2nd day.
On 6-16, 2022 I was having urinary frequency and urgency and lost bladder control. This lasted for about a week. My blood sugar was also elevated for over 2 days. A week later, i started noticing a urinary odor and pain upon urination. On 7-9, I emailed the clinic and they told me to come in on 7-11 for a urinary test. On 7-12, they told me the urinary test was positive for infection. They performed more tests and sent me a prescription of Nitrofurantoin x 7 days. I started it last night. I feel the urinary problem is starting to improve.
Information has been received from a nurse concerning a 62 year old female with sulfonamide allergy, allergy to tetanus toxoid and no pertinent medical history who on 04-NOV-2008 was vaccinated SC with a 0.5 ml dose of PNEUMOVAX *lot # 661065/1021X). Concomitant therapy included influenza virus vaccine (unspecified). On the same day, the patient developed numbness and redness at the injection site. She had to go to an emergency room because she also had 102 degrees F fever. At the time of this report, the patient was recovering. No lab tests were performed. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a healthcare professional concerning her 16 month old grandson with no known allergies and a history of ear infection 2 weeks prior to vaccination(treatment included AMOXIL dose, route and frequency not reported) who on an unspecified date was vaccinated with MMR II. There was no concomitant medication. Subsequently, on an unspecified date the patient developed welts and hives all over his body. The patient also developed swollen joints described as an "Arthus Reaction" and fever of 104 to 105 degrees F for 4 days. The physician was contacted for treatment. Unspecified blood tests were completed (results not reported). The patient was treated with BENADRYL, ROCEPHIN and oral steroids. The physician felt that reaction was due to an unspecified virus and not to the vaccination. At the time of the report, the patient recovered on an unspecified date. There was no product quality complaint involved. The reporter considered the events to be disabling and life threatening. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (dosing details and route of administration unknown) lot # M024683 with expiry date 18-MAY-2018; lot # M023380 with expiry date 11-MAY-2018; lot # L021215 with expiry date 10-JUN-2017 for prophylaxis, which reconstituted with sterile water diluent that was not involved in the temperature excursion. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses experienced a temperature excursion of 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for a time frame of 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
chest pain; felt uneasy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Jul2021 (Lot number: EW0202) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 02Jul2021, outcome "recovered" (Jul2021), described as "chest pain"; ANXIETY (non-serious) with onset 02Jul2021, outcome "recovered" (Jul2021), described as "felt uneasy".  Additional information: Caller stated he has just spoken with agent and reported his adverse event from receiving the first and second dose of the Pfizer COVID 19 vaccine in Jul2021. Caller reported that he wanted to report a concern and reaction and get some information on the Pfizer recommendations for the booster dose of the Covid-19 vaccine. He had the first administration on 02Jul2021, and the second dose was on 23Jul2021. On 02Jul2021, for a day or so after receiving the dose, he had mild chest pain and felt uneasy. He did not monitor his vitals other than that. What was recommended by Pfizer concerning this information? He was required to get the booster for enrolment for the next semester. Is it contraindicated for him to get the booster dose? Caller said that he recovered from all the symptoms that he had previously. He said that his symptoms resolved about 2 days after receiving the vaccines. Additional Vaccines Administered on same date of the Pfizer suspect none. Patient did not require any emergency room and physician office for adverse event. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine: none. Adverse following prior vaccinations: None.   Follow-up attempts are completed. No further information is expected.
I stayed at the pharmacy for almost 30 minutes, due to my history of allergic reactions.  I felt fine, and we left for my cousins house.  On the way there, I had trouble breathing, my throat started to swell shut, and I got hot and sweaty.  I gave myself the epi pen shot, and about 5 minutes later, I started feeling better.  My husband was driving, and we started to turn around, but I seemed to be ok.  We went on to my cousins house, and I felt fine and still do.
Patient was given flu shot and pneumonia vaccine right before discharge.  Patient reports that when he got home he began experience generalized pain, redness and swelling at the injection site, elevated blood pressure, and fever of 103.
This case was reported by a consumer via call center representative and described the occurrence of rash herpetiform in a 59-year-old male patient who received SHINGRIX) for prophylaxis. The patient's past medical history included shingles (outbreak prior to receive SHINGRIX). In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 30 days after receiving SHINGRIX, the patient experienced rash herpetiform. On an unknown date, the patient experienced localized erythema and pain. On an unknown date, the outcome of the rash herpetiform was recovering/resolving and the outcome of the localized erythema and pain were unknown.  It was unknown if the reporter considered the rash herpetiform, localized erythema and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About one month after receiving SHINGRIX, the patient developed a shingles like rash across his back that was similar in location to where he had a previous shingles outbreak. The patient reported that this outbreak was not as severe as previous and he still has a red area on his back and some slight pain but had not seen his doctor about the event. The patient consented to follow up.
Myocarditis  The right side of my chest began feeling sore with sharp burning pain 2-3 hours after getting home and resting at my kitchen table. I was out of breath and would feel excruciating pain whenever I would move around. I thought I was dying or going to die because of the pain I felt and spent the next 3 days resting in bed.
Within first hour of inoculation sneezing, runny nose and watery eyes for the first 24 hours; Within first hour of inoculation sneezing, runny nose and watery eyes for the first 24 hours; Within first hour of inoculation sneezing, runny nose and watery eyes for the first 24 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration on an unknown date (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and medication received within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date, within first hour of inoculation the patient experienced sneezing, runny nose and watery eyes for the first 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events within first hour of inoculation sneezing, runny nose and watery eyes for the first 24 hours was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.