chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; improper stored doses of PROQUAD my have been administered to unspecified patients; This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  Between the dates of 07-JAN-2019 and 01-MAY-2019, the patients received improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route and anatomical location were not reported) lot # R018776 with expiration date 29-DEC-2019 and lot # R027988 with expiration date 30-MAR-2020, for prophylaxis. The doses of the vaccines were reconstituted with properly stored sterile diluent.   The doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were exposed to a temperature excursion of -14 Centigrade degree (°C) to -10°C during a timeframe of 17hours and 21 minutes, and a temperature excursion of -9°c to 8°C (-9.3°C) during 30 minutes, which was detected by a digital data logger. There were no previous temperature excursions. No adverse effects reported.
Pt reports red itchy rash appeared on bilateral arms approx. 4-5 hours post-vaccination. Dry red rash noted on 12/28/2020. Pt states has been taking Benadryl and using topical hydrocortisone cream. Pt states has seen slight improvement.
Approximately 3 minutes after injection, pt. reported that her vision had gone black, her ears were ringing, and she felt faint. I notified the nurse immediately. Within another minute her breathing became rapid and faint. She was given water and coached to breath slowly and deeply. The nurse checked her blood pressure with a result of 67/22. A second BP check resulted in 70/27. The nurses transferred her to the ER. In the ER, a third BP check 20 minutes after injection resulted in a normal reading of approximately 110/70. She continued to take oral fluids for approximately one hour before being released. The medical staff reported to us that this is a completely normal reaction for many people to all vaccinations, and suggested that she should get the second dose of Pfizer vaccine in 3-4 weeks. However, when we check the CDC website we find that these are anaphylactic symptoms and should not get the 2nd dose of Pfizer, so we are greatly concerned and decided to report the event.
Patient received second Covid vaccine 3 days prior to admisssion. He presented to the emergency department for worsening shortness of breath, cough, decreased appetite, and generalized weakness for about 2 to 3 days associated with diffuse abdominal colicky pain.  He reports of a progressively worsening weakness/fatigue over the last 3 days associated with poor oral intake with nausea but no vomiting.
11 days later without warning the non existent injection site suddenly turned red, hot and hard - about a 2 inch diameter circle.  The injection site was not properly placed and is on the front side  (anterior Biceps) of my upper arm and not on the side (Deltoid).
Chills, low grade fever, body aches, headache, dehydration, nausea, pain and soreness at injection site. Started around midnight after receiving second dose that afternoon, and lasted all through the following day.
4/28-4/30-Nausea, Dizzyness, Joint pain, Chills, and Fatique 4/28-??? Migraine/headace and Injection site soreness, redness, itchyness and welt the size of a softball.
Myalgia, Fever, hot and cold chills, back and arm pain Narrative:  N/A
About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold feeling in the chest. Pt reported eating breakfast and being adequately hydrated. Patient returned to vaccine clinic, remained seated for about 30 minutes, drank water, and feeling dissipated.
expired vaccine administered with no reported adverse event; Initial information was received on 28-Jun-2023 regarding an unsolicited valid non-serious case from an other health professional.  This case involves 3 years old female patient who received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/HIB(PRP/T) vaccine [Pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and hepatitis B vaccine for Prophylactic vaccination (immunisation).  On 27-Oct-2020, the patient received a dose 3 of expired suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/HIB(PRP/T) vaccine (lot number: UJ015AAA, expiration date: 26-Oct-2023) via intramuscular route in the left lateral thigh for immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  outcome was Unknown for the event expired vaccine administered with no reported adverse event.  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 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.
Lots of back pain; Fever of 99 F; Severe arm soreness at injection location; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU6207), via an unspecified route of administration in the left arm on 22Mar2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included inflammatory arthritis. Concomitant medications included sulfasalazine (SULFASALAZINE), methotrexate (METHOTREXATE), meloxicam (MELOXICAM) and folic acid (FOLIC ACID) all taken from unknown dates for unknown indications. 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 COVID-19 vaccination. On an unknown date in 2021, the patient experienced a fever of 99-degree Fahrenheit for 4 hours, severe arm soreness at injection location (vaccination site pain), lots of back pain and fatigue. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events lots of back pain, fever of 99-degree Fahrenheit, severe arm soreness at injection location (vaccination site pain) and fatigue was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Body aches; Dizziness; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 16:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Mar2021 at 08:00, the patient experienced body aches, dizziness and brain fog. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, dizziness and brain fog were recovered with sequelae an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
PT RECEIVED 2ND DOSE OF BIVALENT BOOSTER. CURRENTLY, GUIDELINES INDICATE PT SHOULD ONLY RECEIVE ONE DOSE OF THE BIVALENT BOOSTER. PT WAS NOTIFIED OF  ERROR VIA PHONE ON 02/03/2023. PT REPORTS NO ADVERSE EVENTS AND WAS INSTRUCTED TO CONTACT PHARMACY, DOCTOR, AND/OR VAERS IF ANY ADVERSE EVENTS DEVELOP.
Cold, ear infecation, lack of: Motor skills, not social, lost words, does not talk any more.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Dizziness / Lightheadness-Severe
Approximately 3 weeks after vaccine (12/14/21) I started feeling clogging in my left ear and hyperacusis and tinnitus. On December 20th went to Dr. ENT. No visual sightings of anything wrong with ear. No infection, etc. Had hearing test that proved a loss of hearing in the high frequency range on left ear. Took 10 day round of steroids with no resolve.  Had MRI with no findings. Also took 10 days of amoxicillin and then another 10 days of Cefdinir with no resolve. Still have all the symptoms as of 2/22/22 with no improvement
rash devel around site of inject w/in 30 mins; approx 6 hrs later rash appeared over entire body & about 3 hrs p/that ran t102; when pt awoke in morning 6 hrs later was sx free & felt fine;
Fever started on the evening of the day of the shot and continued for the whole next day. It peaked at 102 degrees.
Stated that approx 24 hours after receiving pneumovax 23 injection, got red blotchy areas around injection site and underneath left arm.  Had no pain at that point.  Then approx 5 p.m. that evening, client went to get food out of the oven, and realized that her left arm was so painful, that she could not reach arm out to remove food from oven.
This is a spontaneous report from a contactable nurse. A 82-years-old male patient received PREVNAR 13 (Lot number: I31687, Exp date: 21Sep2016), intramuscular on 27May2015 at 0.5 ml single dose. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium, tamsulosin hydrochloride, ADVAIR DISKUS, DALIRESP, SPIRIVA, VENTOLIN, azithromycin, ethambutol, omeprazole, albuterol, COQ-10, fish oil, MUCINEX and aspirin. The patient had a redness from his knees to around his back up to his shoulder. The patient was in the hospital for 48 hours and received methylprednisolone 4 mg and BENADRYL. During hospitalization the patient was not better and there was a bad sun burn except that the skin not broken.
Nurse went to administer flu vaccine and states she pushed on plunger to express drop of vaccine to ensure no air would be in injection.  She then states she inserted needle in patient's arm and started to depress it but it would not depress any further.  She then removed from patient arm and informed patient that there was no flu vaccine in that syringe and would have to give patient another shot, which she did.  Upon inspection of the syringe, it did appear the syringe/needle area was crooked so may have been an error in manufacturing process.  No other syringes in that box had any issues.
left arm 3 inches bigger than right; left arm hard; left arm hot; temperature between 99 and 101; tired; achy; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and TETANUS VACCINE for prophylaxis.   The patient's past medical history included shingles and lymph node excision. Concurrent medical conditions included asthma, type ii diabetes mellitus and mastectomy bilateral.   In July 2022, the patient received the 1st dose of Shingrix, PNEUMONIA VACCINE and TETANUS VACCINE. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's comment: The patient self-reported this case. The patient had a Shingles vaccine almost two weeks ago (the day before reporting) and still having side effects. The patient reported that 13 days ago (the day before reporting) he/she received the first dose of Shingrix into unknown arm, Pneumonia vaccine and Tetanus vaccine and the patient left arm was three inches bigger than toe over a wheel and hard and hot.  The patient's body temperature ranges between 99 and 101 degree F. Tylenol got it down to 99 degree F. The patient had been tired and achy. The reported that tomorrow it would be two weeks. Because of the lymph nodes removed from right arm during mastectomy everything was to be done in left arm. The patient asked was still how long before this end and would patient have the same problem with the second shot. The patient had shingles and he/she knew how awful it was. The patient received a dose of Pneumonia vaccine and Tetanus vaccine and less than 2 weeks patient experienced swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain. It was unknown if the reporter considered the swelling arm, induration, extremities hot feeling of, fever, tiredness and pain to be related to Pneumonia vaccine and Tetanus vaccine. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Arm was sore yesterday but today I feel sick. Took my temp at 10am is was 98.2 again at 4:30pm is was 100.2
Pt skin turned red and splotchy gave 50mg  benadryl liquid . Pt waited aprox 20min and was able to return home. Followed up with patient that evening and she was feeling fine. Had no other symptoms arise.
Patient was scheduled for a Pfizer Bivalent vaccine but received a Pfizer Monovalent vaccine in error.  No adverse reaction was reported.
Nausea, extreme diarrhea, vomiting, swollen stomach, dehydrated, etc. Hospitalized from 2/13 (4AM) to 2/15/19.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 15 years old, female patient with no pertinent medical history reported. On 04-DEC-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Initial unsolicited report received from a nurse on 1 October 2015. This case involves a three patients (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced chills and fever. At least one individual patient was unable to work, unsure of the other 2 patients. Laboratory investigation and corrective treatment were not reported. On an unspecified date, the patients were recovered from chills and fever, however the outcome of the event unable to work was not reported. List of documents held by sender: none.
I was getting a massage 3 days after my second vaccine on 2/18/21 and when the massage therapist massaged my left arm it was so sore and tender she had to really lighten up. I had muscle soreness and diminished range of motion in my left arm until a week or two ago! The soreness at the injection location when rubbing it has nearly completely vanished. I still do not have complete range of motion, however the soreness in the upper arm has gone finally! It took me a long time to realize this was most likely a side effect from the shots, because my other arm hurt and has loss of range of motion. However, I did not do anything to my left arm other than get two vaccine shots in it.
Within a day began red bump outbreak that was inflamed.  With in two weeks what I thought was excema spread behind her knees.  Within a month it spread up her legs , within a year out of control red whleps and blisters insane itching, totally misdiagnosed during this time, ultiamtely diagnosed with Molluscum and Excema.  I believe she contracted the Molluscum Pox virus from the vaccine for Chicken pox becasue I can pinpoint her symptoms to the vaccine and not before.  She has subsequently missed weeks of school and had very painful treatments to try and rid herslef of this pox virus.  I believe the Chicken Pox vaccine in conjunction with her mild execema prior to the vaccination caused her to get Molluscum.  Her immune system is wrecked as a  result of the ongoing Molluscum and Execma.  I can't help but wonder how many other children with execma have the same thing happen after their chicken pox vaccine?
On 2/5/2021, 1 week after receiving the vaccine I noticed the injection site was red, warm, felt hard and was sensitive to the touch.  It is also slightly itchy at times.  As of today, 2/11/2021 I continue to have redness (increased area), heat, itchiness and sensitivity.  The hard feeling is gone.  I have not taken any medications internally or topically nor have I sought medical attention.
Pt blames flu shot ruined his health and he is always sick now. Brought in not from MD's office saying he experiences fevers, cough, chills after receiving flu shot. According to consent form he said he had a cold 2 wks ago and feels fine at the time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "degenerative disc disease" (unspecified if ongoing); "Barrett's esophagus" (unspecified if ongoing); "Bipolar II" (unspecified if ongoing); "arthritis" (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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2023) Positive, notes: positive home test beginning on 14Sep2023. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).  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.
Patient complained of tingling in her ears, chest, and back of throat. Patient denies difficulty breathing, difficulty swallowing, and nausea. BP 131/72, HR 91, O2 sat 95%. Patient assessed by physician and monitored.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA ANGIOEDEMA, SUBSEQ
Patient received Rotateq #2 on 1/3/07. Developed diarrhea 3 days later, lasted 10 days.
muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; From thumb finger till middle figure of both hands are numb especially after getting up daily.; The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention); Both gums are very soreness and distention; Both gums are very soreness and distention; Stuffy nose; night sweats; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 66-year-old, on 20Feb2021, single dose for COVID-19 immunization. Relevant medical history included diabetes. The patient had no known allergies. Patient is not pregnant. Concomitant medications included metformin, thiamine hydrochloride (VITAMIN B1 [THIAMINE HYDROCHLORIDE]) taken for covid-19 immunisation; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (left arm), at the age of 66-year-old, on 23Jan2021, single dose for COVID-19 immunization and experienced muscle and nerve on both side of face (especial jawline area) are uncomfortable. On 21Feb2021 at 07:00 am, her muscle and nerve on both side of her face (especial jawline area, marionette line area, nasolabial folds, both temples and lower eyelid region) and the area along the back of both ears on the back head are very uncomfortable. From thumb finger till middle figure of both hands are numb especially after getting up daily. The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention). Both gums are very soreness and distention. Stuffy nose and night sweats in the whole body happen a few times daily after the 2nd dose as well. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
I was 20 weeks pregnant when I received the 2nd dose. Day after the shot started feeling a bit of fatigue and shortness of breath.
Patient experienced nausea, lightheaded, and sweating after vaccine. After waiting 10-15 mins & propping feet up patient felt better. Left pharmacy.
Approximately 2 weeks after the vaccination of booster shot, around 11/29/2021 hives began to appear all over my body that was aggravated by heat and fragrances. I took Claritin that did not do much, I was given a steroid pack for 6 days and helped, however once I finished the steroid my symptoms came back. I then was advised to take Claritin and Pepcid HC for 2 weeks and helped calm things down, and it began a flare up again. I am still experiencing these hives and itchiness however heat seems to trigger it and the rash  spreads all over.