chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on neck and chest, very itchy, appeared 3 days after both shots. This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8729) via an unspecified route of administration in the left arm on 13Apr2021 at 13:45 (at the age of 64-years-old) and  second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 04May2021 at 14:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure, thyroid disease, high cholesterol and allergy to NSAIDS, sulfa and some penicillins. 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. The concomitant medications included irbesartan (AVAPRO), levothyroxine (MANUFACTURER UNKNOWN), lovastatin (MANUFACTURER UNKNOWN) and fish oil (OMEGA 3); all from unknown dates for unknown indications and unknown if ongoing. The patient previously took clarithromycin (CLARET) on an unknown date and experienced allergy. On 16Apr2021, the patient experienced rash on neck and chest, very itchy, which appeared 3 days after both shots. The patient reported that she used steroid cream Triamcinolone Acet 0.1% CR and the rash went away after 7 days. Therapeutic measures were taken as a result of the reported events which included treatment with triamcinolone acetonide cream (MANUFACTURER UNKNOWN). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on neck and chest, very itchy  was resolved on an unknown date in May2021. No follow-up attempts are needed. No further information is expected.
Patient called and said he had soreness, redness, swelling at the site of injection.  It also looked discolored at the site of injection.  He had a fever, body aches and a headache.  He received the flu shot on friday and showed all of the above symptoms overy saturday/sunday.  The brusing around the site of injection was still there on monday.
Severe left arm pain on 4/12/21 started @ 3am. Three full days before I could move my arm more than slight lateral movement. As of 5/4/21 left arm still hurts to lift above my head or rotate, I can't carry anything of too much weight (1-2 lbs) with it or sleep on my left side.  While driving it hurts to use left arm to turn steering wheel.   Severe chills set in on 4/12 around 3pm and turned into sweats overnight with random pain that woke me up in middle of the night in right foot, left ankle, right hand, hips.  I also needed my ventolin inhaler 3 times the evening of 4/12.  Usually, I only need my inhaler when I'm around cats/smoke/ill(upper respiratory infection).
Fever and irritability since vaccines fever on 6/4/14 at 10:00 am 101.3 (R).
11sep90 pt vax hepta b. 18sep90 pt ex h/a, malaise, n, diarrhea, anorexia, and arthralgia. sx resolved
8th of January started developing a sore throat which increased leading to the 10th when I went to a urgent care where I was diagnosed with the Omicron variant of covid.  Suffered with with for 5 days.
The patient arrived the pharmacy on 10/23/23 with her spouse and filled out a consent form for a Covid-19 vaccine. After completing the consent form, the pharmacist processed the form incorrectly as Fluad Quad flu vaccine and failed to verify the vaccine with the patient. The vaccine was then given to our staff nurse to administer to the patient and again was not verified with the patient.  As a result, the patient was given a flu shot and not a covid-19 vaccine as requested. The patient then contacted the pharmacy later after noticed her and husband's paperwork talked about influenza and not Covid-19. The pharmacist on duty verified the error after pulling the consent forms and then inquired about side effects or other issues. The patient reported no side effects or ill harm, however, was frustrated that the wrong vaccine had been given. After talking with the on-duty pharmacist, the patient was very understanding about error and decided to come back to the pharmacy on 10/25/23 to receive her covid-19 vaccine. This vaccine was given without any issues.
fever 10.4 7 lightheaded morning p/vax;took APAP-felt better exam nl by MD;
Swollen lymph nodes in armpit on left side,  Raised painful "bump" at injection site
Pt informed that her throat was swelling a bit. Pt was able to talk and wasn't in any distress. Pt was walked down to ED where  she said the roof of her mouth was numb. Pt was checked in to ER and looked at by doctor
Shortly after the 2 vaccines were given (about 1 or 2 minutes after), the patient stated that she started "seeing black dots" and felt dizzy. Thankfully she was still in the chair and the chair did have arm rest. We got the patient some water and her father also brought her a bottle of water. Within just about 5-10 minutes she felt alright again.
Brief but very severe abdominal pain waking me from sleep. Pain was so intense I almost passed out. It restocked just as quickly, lasted 3-5 min
Woke up to entire body trembling and jaw clenched.  Took tylenol and used heating pad and controlled breathing to stop.  About an hour later started sweating and  took temperature which registered 100.1.  About an hour later took temperature again and was down to 99.5.   within 4 hours felt better and temperature was in normal range.
transaminitis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacturer unknown), for COVID-19 Immunization. The following information was reported: HYPERTRANSAMINASAEMIA (hospitalization), outcome "unknown", described as "transaminitis". The event "transaminitis" required emergency room visit.  Clinical Course: Patient presented to the emergency department with transaminitis and tested positive for COVID and was admitted to the hospital one day after COVID 19 booster vaccine was administered. Provider is unsure if this was a Pfizer product or not.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
A patient got the flu vaccine on 10/07 and a couple days later developed a large welt below the injection site. She said it had some blisters too. She came the next day and I looked at it and it was swollen and red but no blisters. It seemed to be below the injection site.
administered Only the Liquid Component; administered Only the Liquid Component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA689A, expiry date 1st April 2023) for prophylaxis.   On 17th December 2021, the patient received Menveo. On 17th December 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the liquid component of (MenCWY) of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Myalgias. Pain and swelling at injection site (left arm). URI symptoms. Trial on NSAID - no help. On prednisone, ice.
patient's mother explained patient complained injection seemed higher on her arm than normal and has been having arm pain ever since the injection.  her physician said she would need an mri to properly diagnose the root cause.
Localized redness and swelling to right thigh.  Mother gave patient Benadryl for 2 days.  Lasted for 48 hours.
This case was reported by a physician via call center representative and described the occurrence of cataplexy in a 57-year-old male patient who received FLULAVAL (batch number AFLLA687AA, expiry date unknown). Previously administered products included FLULAVAL vaccine (batch number AFLLA591BA). Concurrent medical conditions included multiple allergies (a lot of), pneumonia (issues) and blood pressure high. Concomitant products included Potassium. On an unknown date, the patient received FLULAVAL. In March 2012, an unknown time after receiving FLULAVAL, the patient experienced cataplexy (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization and GSK medically significant), Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant) and viral infection (serious criteria hospitalization). On an unknown date, the outcome of the cataplexy was not recovered/not resolved and the outcome of the unable to walk, Guillain Barre syndrome and viral infection were unknown. It was unknown if the reporter considered the cataplexy, unable to walk, Guillain Barre syndrome and viral infection to be related to FLULAVAL. Additional details were provided as follows: This case was previously reported to a doctor. The patient had an aggressive immune system. Concomitant medication also included high blood pressure medication. The patient received a FLULAVAL vaccine. In March 2012, he had a very rapid onset of symptoms that progressed over 6 months and that incapacitated him. The symptoms required several hospitalizations for several weeks and numerous numbers of tests were done. In March of 2012, he developed a viral severe cataplexy and Guillain-Barre syndrome. It was a viral infection that made him lose the ability to walk. He had to go through rehabilitation to learn to walk and received treatment. He was disabled and could not walk more than 10 feet. The patient had received some vaccines other than FLULAVAL and suffered from pneumonia issues in general but he did not have that information with him at the time of reporting. The reporter wanted to get more details about the H1N1 nuclear protein used within the FLULAVAL, as he believed that activated the viral infection. He also mentioned a vaccine made by different manufacturer that he received afterward, 2013-2014 MPV injector 94ZN4; expiry date 30th June 2014, a different set of expiration that he was not sure what it meant (26 July 2013). However, as per our sales data the batch number 94ZN4, corresponded to FLULAVAL.
Patient fell from chair in waiting area and experienced seizure-like activity for 5 to 10 seconds. EMS was called and promptly arrived and took patient to hospital.
Extreme shivering from being cold almost convulsive,fever, headache, nausea with dry heaves, fatigue. Arm was sore and slightly swollen. At about 4 hours after I smelled smoke and dirty dish rag smell. That didn't last. Other symptoms started 12 hours after given shot. It was immediate like turning on a light switch. I slept until 5:30 the next day, 2/3/2021. Was able to eat a bit of soup and went back to sleep until next morning. I was able to go to work on 2/4/2021 but experienced some weird brain fog and fatigue. On 2/5/2021 my arm had a large red ring around injection site and hives below it. I remained fatigued and lack of appetite for 4 days or so.
My sense of smell has changed.  I frequently smell a "chemical" odor (an acrid sulfur, or rotten iron smell) that doesn't actually exist, I happens especially when I'm eating my food.  This "ghost smell" also occurs at relatively random times throughout the day.
pt in  for shots 25MAR97;spiked temp @ 12noon;keep spiking a temp of 102-105.5 every 6-8hr through 27MAR95 evening;parents were given pt Ibuprofen every 6hr & APAP in between every 2-3hr;no other sx;went to MD 25MAR97;
mom noted pt had hives on hands, legs, trunk & back of ears 430AM on 19AUG94; MD gave DPH; t98.8 ax; hives now generalized rash; no react @ IM site;
Pt recv vax on 12/9/98; on 12/10/98 pt exp fever, joint aches, erythematous macular rash on neck, face & trunk
Repetitive behavior, repeat phrases, hand flapping, not hitting milestones for appropriate age.
Extreme pain in arm pit of the arm where Covid vaccine given (NOT at injection site) almost unable to move arm for 24 hours. Felt like stabbing pain in underarm. 5 days later noticed significant bruising along underside of arm radiating down from armpit to elbow. Bruising also noted on the right side of torso (along area of bra strap line). Both sides of bruising look like they ?spread? from arm pit area and ran down side of torso and arm to elbow. Bruising is not at all painful.
Got only one dose on june 2018; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.
Right sided Lip tingling with facial drooping. C/o neck pain and stiffness on right side. States eye will not close completely and is drying out.
11/15 significant arm pain, chills, nausea, fatigue.  11/16 to 11/27 arm pain and fatigue gradually decreased.  11/28 to 12/29 arm tender to touch at injection site, very slight ache in upper arm, fatigue would come and go sometimes severe.  12/29 injection site painful to touch, upper arm aches, severe fatigue.
Got covid.  tested positive on May 4.  Symptoms similar to a cold with a hacking cough.
8 days after MMR vaccine, spiked a 103.4 fever that will not break even with Tylenol and Motrin. My son has the chills and is shaking from being cold, even though fever is high.
Redness; itchy; tender; This spontaneous case was reported by a health care professional and describes the occurrence of   in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021 Contains Age of the patient was added
Very lethargic, fever with hallucinations.  Crying.   Very achy & weak. Headache.
12 hrs after vaccine. symptoms runny nose, tenderness on left arm, headache, dry cough
I would go in for lab work and they would do a urinalysis. I am prone to kidney infections. I was going into kidney doctor. I can't say that I noticed anything different. I just felt really tired. My lab work in September reflected that I was in kidney failure. He advised that he would keep monitoring me to see if it would resolve itself. I have had a Urinalysis since then and I had an elevated WBC but otherwise everything. I have another one scheduled for November.
Patient received HAVRIX in left deltoid followed by TYPHIM in right deltoid about 30 seconds later. Right after receiving TYPHIM, he stated he was not feeling well and lost consciousness for about 15 seconds. He then came to and completed recovered. Pt denied medical attention or any treatment.
Local redness and induration on 06/29/12 with increasing pain surrounding indurated area.
AST and ALT for liver was tagged as high; AST and ALT for liver was tagged as high; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in deltoid right on 12Mar2021 10:00 (at the age of 76 years old) (Batch/Lot Number: EL9267) as 1st dose, single dose for COVID-19 immunization and palbociclib (IBRANCE, 75 mg tablet), oral from an unspecified date (reported as almost 4 years ago) (Batch/Lot number was not reported) and ongoing at 75 mg, cyclic (once daily for 21 days) for metastatic breast cancer that has gone to the bone and lung. Medical history included metastatic breast cancer that has gone to the bone and lung. There were no concomitant medications. On 12Mar2021, AST and ALT for liver was tagged as high. AST was 13 in Feb2021, 47 in 15Mar2021. ALT was 11 in Feb2021 and 48 in 15Mar2021. The action taken in response to the events for palbociclib was dose not changed. Patient is taking Ibrance and Ibrance requires her to have a blood test done before starting the next round of Ibrance so she went to have it done. Patient will have blood redrawn in a week, they said to call and advise in case there are. No additional vaccines administered on same date of the Pfizer suspect. Adverse Event (AE) did not require any visit to emergency room or physician office. Patient had a video appointment scheduled already. No prior vaccinations (within 4 weeks). Outcome of the events was unknown.  No follow-up attempts are possible; no further information is expected.
Limited range of motion in arm, constant pain in arm (at/around injection site, down through arm, around shoulder and upper back); growing  red "halo" around injection site; flu like symptoms.
First nausea and diarrhea then swelling in my parotid gland.  I had COVID, I believe, in January 2020.  Severe respiratory symptoms with loss of taste.  Exhibited swelling of glands on the right side of neck at that time.
This case was reported by a physician via sales representative and described the occurrence of fever post vaccination in an unspecified number of infant subjects of unspecified gender who were vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates the subjects received unspecified doses of PEDIARIX (unknown). At unspecified times after vaccination with PEDIARIX, the subjects experienced fever post vaccination. The physician indicated to the sales representative that PEDIARIX was discontinued in her practice "due to parents reports of fevers post vaccinations at 2, 4, and 6 months of ages; was determined by the physician to be vaccine fever and cause her to stop using PEDIARIX in her practice". At the time of the report, no other information of time intervals or lot number was available. At the time of reporting the outcome of the fever post vaccination was unspecified.
HCP reports that improperly stored vaccines were administered; No Additional AEs.; This spontaneous report has been received from a medical assistant referring to a patient of unspecified age or gender. Information of concurrent condition, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On an unknown date, the patient administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) injection (1 dosage form (1 time dose), lot# W028561, expiration date 06-MAR-2024, strength, route and anatomical location were unknown) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at 7.7 degree Fahrenheit (F) for 8 hours and 54 minutes (product storage error). There was a previous temperature excursion through which the suspect vaccine was underwent temperature excursions at 7.7 degree Fahrenheit (F) for 2 hours and 18 minutes. No additional adverse event (AE) was provided (no adverse event).
At 7:00 pm I started experiencing sinus drainage & stuffiness. When I went to bed at around 8:30 P.M. I Noticed  some difficulty getting enough air into my lungs ( 11/2020 Ablation for A fib, compromised phrenic nerve Not usually SOB unless high physical demand ) At 9: 30 P.M started moderate  shacking/Chills until around 3 A.M. with little sleep. Then some sleep until 5:00 A.M. woke up with 102.4 temp and felt lousy with joint pain in various joints that do not typically hurt. Did not go to work spent most of the day in bed until 4:00 P.M. Feeling somewhat better now
Patient had symptoms of swelling, itching & breathing difficulty. Prednisone, BENADRYL, & ALLEGRA were prescribed and patient's symptoms resolved. This happened about 12 hrs after the flu shot.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in 2015). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 days after receiving SHINGRIX, the patient experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema. On an unknown date, the outcome of the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema were recovered/resolved.  It was unknown if the reporter considered the headache, nausea, chills, fever, stomach pain, joint pain, muscle pain, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 58 or 59 years old. The patient did not have the date when she had the 1st SHINGRIX vaccine with her at the time of the reporting. However, the patient had the injection at night and the next day after the 1st dose of SHINGRIX, she experienced headache, nausea, chills, fever, stomach pain, joint pain, muscle aches, injection site pain, red at the injection site and muscle pain at the injection site. The symptoms went away within a week. The injection site pain did last for a longer time, that took a very long time to go away. The patient did not consent to be followed up. For tolerance to next dose, refer case US2018226724.
About 3 inches down from injection arm is swollen and red. Doesn't hurt or itch and has gotten a little better. Talked to patient and told her if doesn't go away in the next day to call physician and follow up to make sure nothing serious.