chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & immed there were 3 red blotches on forehead &  one on top of head;pt cried only briefly;no resp signs of discomfort;there was swelling & redness @ site of rt leg inj;also some redness of lt leg;blotches, warm to touch;
Pt woke up on 7/13/2012 with redness and swelling at area of injection. Pt denied pain, itching or fever. Advised to use cool compresses and TYLENOL or MOTRIN for relief.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and swelling arm. In April 2018, the outcome of the erythema of extremities and swelling arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient had swelling and redness of the whole arm following injection of SHINGRIX which were resolved within 3 days. The batch number reported for SHINGRIX (9XC595) did not exist and was updated to 9XC39, as per sales database.
A non-serious spontaneous report of fever and flu symptoms has been received from a nurse concerning an eight-year-old male patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 27-Oct-2010, the patient received FLUMIST. On 08-Nov-2010, the patient developed a fever of 104 degrees and flu symptoms. On 09-Nov-2010, the patient was examined by his physician. A flu swab test was negative. The events, fever and flu symptoms, were ongoing.
This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a child (4 to 6 years of age) male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX at 0.5 ml. At an unspecified time after vaccination with KINRIX, the subject experienced cellulitis and swelling arm. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with KINRIX.
Resident was disoriented (usually alert and oriented), chills and began vomiting. Reaction occurred within 5-10 minutes of vaccine administration.   911 was called while awaiting for EMS to arrive. Resident was administered an EpiPen in the right thigh. Vomiting subsided and resident reported feeling better. He was transported to the hospital via ambulance.
Information has been received from a consumer concerning a 12 month old patient who on August 2005, was vaccinated SC with a 0.5 mL dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Suspect vaccination included a dose of varicella virus vaccine live. In December 2005, the patient developed a systemic rash and fever. Unspecified medical attention was sought and the patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Vaccine 1: flu like symptoms, severe headache, rash, severe body aches, fatigue for about 4 days.  Vaccine 2: Nausea, diarrhea, fatigue, severe body and  muscle and joint aches, headache, temporary loss of taste and smell again. Lasted about 30 hours. Diarrhea persisted for 6 days.
Information has been received from a pharmacist concerning a female who on 12-FEB-2008 was vaccinated with Zostavax (Oka/Merck). On an unspecified date, the patient developed an erythematous rash on her face and neck. The reporter indicated that there were no pustules and that the rash did not resemble shingles or chicken pox. The patient was seen in the physician's office, treatment was not reported. At the time of this report, it was indicated that the patient had not recovered. A product quality complaint was not reported. Additional information has been requested.
Pin point red spots, as rash areas with raised bumps that are blistering and popping with fluid inside.
rash all over her body; developed a severe rash all over her body and had a systemic reaction; This is a spontaneous report from a non-contactable physician (reported behalf of one of his patients) received from a regulatory authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The physician reported that he had one female patient, which this happened about 2 weeks ago, that had the second dose of the Pfizer Covid 19 Vaccine and after 5 days the patient developed a severe rash all over her body and had a systemic reaction on an unspecified date. Reporter stated that the patient was taken to the ER and was treated and now was doing fine and the patient took Prednisone. Reporter stated the patient's son called him and the patient's son stated he called Pfizer to report the adverse events and Pfizer stated that the primary care provider should order some lab tests for the patient, which he was not aware of. Reporter stated he just wanted to see what lab tests he should order for this allergic reaction as he was unsure and felt bad because the patient's son called him, and the reporter was not aware of this and with the doctor promoting the vaccine he felt he should find out. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Hospitalization 9/23/21.    Received 2nd dose of Pfizer COVID vaccine 2/20/21
Severe migraine that needed a toradol shot, a few weeks later the injection site was red itchy and inflamed.  Site still hurts but no longer has itchy Ed?s or inflammation.
This is a spontaneous report from a Pfizer-sponsored program. Report from a contactable consumer reported for herself.  A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL1283, expiry date was not reported), via an unspecified route of administration, administered in right arm on 26Jan2021 (at the age of 75-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Previously patient had started cefalexin monohydrate (KEFLEX) on 13Jan2021 for an infected tooth. Patient had first dose of the COVID-19 vaccine shot on 26Jan2021. Patient symptoms started on Saturday, 13Feb2021 but patient was diagnosed yesterday, 15Feb2021 with the infection. Patient had to go to the dentist for a tooth infection and yesterday patient started taking an antibiotic. Patient asking, second vaccine appointment was schedule on tomorrow. She inquired as- should get the second shot. Patient clarified that they put her on Keflex 4 times a day for 7 days. Patient started it last night. The outcome of event was recovering.  Follow-up attempts completed. No further information expected.
Soreness in right shoulder that didn't go away with time. Pain down right arm, elbow and forearm. Normal daily activities bring pain with use of right arm. Manageable but painful.
Information has been received from a registered nurse concerning a 6 year old male with a past medical history of "congenital posterior urethral valves" and no allergies who on 0/27/1996 was vaccinated with a dose of varicela vaccine. On 11/27/2001, the pt "broke out in chicken pox." The child was presented to the doctor's office on 11/28/2001 with "four vesicule like lesions, at right upper extremity." Follow-up info reported that the four vesicles were fluid filled and itchy. It was noted that the pt was afebrile. There were no other symptoms reported. The pt sought unspecified medical attention. It was reported that the pt recovered on 12/03/2001. No further info is expected.
patient complaining of redness at injection site, itchiness, hot to touch, rash.  onset next day.
Pt recvd booster dose Engerix-B & 4 hrs later had flu-like sx, vomiting; lasted 2 days; resolved;
Patient developed pronounced localized swelling at the injection site within 24 hrs. of the injection, and began complaining of pain radiating to the extremity distal to the injection site. Patient spontaneously displayed seizure-like behavior for 8-10 seconds during breakfast approximately 46 hours after injection. Patient was postical for 2 hours after event, and desired only to sleep. Patient was taken to lab for a blood panel draw, followed by an office with the pediatrician. Follow-up with a neurologist for an EEG was recommended.
Patient complained of facial numbness and tingling, felt the ? same to penicillin allergy?; no other symptoms were reported Patient denied medical transport and signed AMA form Family will drive patient home
Individual was under the age of 18 when he received the Moderna Covid vaccine. No adverse reaction was witnessed during the 15-minute monitoring period.
Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Fatigue, Chills Narrative: No further details given
Information has been received from a Certified Medical Assistant concerning a 76 year old male patient with drug allergy to triazolam who on 30-NOV-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659147/1381U. Concomitant therapy included influenza virus vaccine (unspecified), vitamins (unspecified) and zinc (unspecified). On 30-NOV-2007, the patient developed injection site redness, swelling, warmth and pain. Medical attention was sought by the patient. At the time of this report patient had not recovered. No other information was available at this time. Additional information has been requested.
Vast increase in OCD symptoms, school aversion . Patient should not have received this test, even though he is over 18, he worked at that pharmacy and they told him to take it. He felt it was ok, because "everyone was taking it", but everyone DOES NOT react the way he does to vaccines, having suffered for years from the HPV vaccine he took years earlier.
Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Jul2021, the patient experienced fever. Patient reported that since morning patient don't have fever but temperature was constantly staying above 99 degrees Fahrenheit. Patient stated that "it is 99 but the thing is it is not going you know below 99, it is staying around 99, 99.2, 99.3 and so on". The patient underwent lab tests and procedures which included body temperature: 99 fahrenheit on 19Jul2021, body temperature: 99.2 fahrenheit on 19Jul2021, body temperature: 99.3 fahrenheit on 19Jul2021. Therapeutic measures were taken as a result of fever included some over the counter medicines (Further clarification unknown). The outcome of the event fever was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Sore arm almost immediately. Almost 24 hours later, presented with swollen lymph node in neck, soreness, fatigue, feeling feverish/hot flashes, and headache. 36 hours later presented with night sweats and episode s of feeling feverish/hot flashes. 48 hours diarrhea and upset stomach. Night sweats, feeling feverish/hot flashes, and  upset stomach have continued for the next two nights/days so far
Nephrotic syndrome, currently taking metoprolol and furosamide, more blood tests next week
Rash starting at injection site and gradually spreading to my scalp down to my toes over a weeks time. It is now the third week and still breaking out and itching terribly.
Broken out in hives in many places on my body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broken out in hives in many places on my body) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced URTICARIA (Broken out in hives in many places on my body). At the time of the report, URTICARIA (Broken out in hives in many places on my body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
pt recv vax & 10min p/vax very pale, stated dizzy, felt clammy;blurry vision w/couldn't hear out of rt ear;pt leaning against mom;pale, cyanotic lips, skin loose bumps;
Sore arm only for first 48 hours post-vaccine. However started feeling ill 48 hours after vaccine and then with fever of 101F, vomiting and stomach pains 72 hours after vaccination. Resolved by 96 hours post-vaccination.
Extremely sore at injection site. General overall loss of energy after both doses, with the pain and swelling doubled in size and intensity following the second dose. Dose #1 date: 04/09/2021. Dose #2 date: 05/07/2021.
Moderate swelling of R anterior thigh less than 12 hrs post Prevnar #4, swelling times 2 days.
pt exp red blotches all over body following DTP vax also became limp; pt recvd DT & had similar event;
Fever (101F) , fatigue, headache, general muscle pain starting at ~4:00AM on the day after first vaccination and resolving overnight the next day.
Patient called to state that 1 week after receiving his influenza vaccine he is still experiencing redness and itching at the site of injection.
Diarrhea began the evening of the shot, very urgent and very often for at least 3 weeks.  After 3 weeks gradually became not as urgent but still daily and with every bowel movement.  Finally 2 months later, it has slightly subsided.  Some meals after the first few weeks seem to trigger but can't pin point what the offending food might be and I've never had food cause this type of reaction. The current food reaction  will usually be an episode or two and then get back to semi normal bowel movements.
Lightheadedness/dizziness the second day after receiving the shot (was fine the day after).  Couldn't stand for more than a few minutes without support.  The third day still a bit lightheaded/foggy, but much better than the day before.
Nose bleeding; Second dose missed; Bad dizziness; High blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Nose bleeding), DIZZINESS (Bad dizziness) and HYPERTENSION (High blood pressure) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, CLONIDINE and ATENOLOL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HYPERTENSION (High blood pressure) (seriousness criterion medically significant). On 24-Jan-2021, the patient experienced DIZZINESS (Bad dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced EPISTAXIS (Nose bleeding) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Second dose missed). At the time of the report, EPISTAXIS (Nose bleeding) and DIZZINESS (Bad dizziness) had resolved and HYPERTENSION (High blood pressure) and PRODUCT DOSE OMISSION ISSUE (Second dose missed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Blood pressure measurement: 180x105 (High) High Blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was evaluated at two different Emergency Departments on four separate occasions. Laboratory examination included CT scans, X-ray and other test with results were not provided. Treatment included antibiotics. High Blood pressure that started approximately two days after the vaccine and lasted for a month or two. Bad dizziness that started approximately two days after the vaccine and lasted for a month or two.  Bloody noses that lasted for the past several months, usually occurring in the morning but also occasionally happening in the evenings.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, noting the patient's con meds as confounders.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up report included reporter's information, reported events medical care, Duration and onset of the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, noting the patient's con meds as confounders.
Very painful arm 8/7/2012 (more than normal vaccine pain) morning of 8/8/2012 patient woke up to redness on injection arm from elbow to shoulder, with swelling on tricep, patient took BENADRYL.
Severe wrist left pain starting day after flu shot, progressively worsening each day. F/U with ortho DR. Thought it was Fracture. Diagnosis Dequairvains F/Vaccine.
SHOT GIVEN ON FRIDAY 8:30 AM  3/17/06. PAIN IN ARM AT SHOT LOCATION STARTED IN THE AFTERNOON AND THE PAIN SPREAD THROUGH MY MUSCLES. MY SKIN WAS SO SENSITIVE I COULD NOT BE  TOUCHED AND ALL MY MUSCLES ACHED. AT FIRST THE SHOT AREA WAS NOT RED BUT LATER BECAME INFLAMED AND SPRED OVER MY ARM. I COULD NOT GET OUT OF BED AND EVERY MOVMENT HURT. NO APPETITE. ON SATURDAY I WAS CHILLED & ON SUNDAY I WAS HOT. MONDAY, I AM UP AND ABLE TO FUNCTION BUT MY ARM IS STILL INFLAMED AND SORE.  I DIDN'T THINK TO TAKE A TEMPERATURE UNTIL SUNDAY AND IT WAS NORMAL. I VOMITED A LITTLE BILE ONE TIME. NO DIARRHEA.  THE VACCINE WAS PNEUMOCOCCAL POLYSACCHARIDE.
Headache unresponsive to Tylenol or aspirin and fatigue resulting in no energy for activity beginning the evening of vaccine and continuing for 36 hours with headache and fatigue dragging on intermittently for another 18 hours
Patient is 71y.o. male who was admitted to the hospital with gait instability and mechanical fall --xray w no evidence of fraction; seen by PMR and PT/OT --recom tylenol and lidoderm patches for pain control--PT recom home w home care ;  Tested covid + upon admission --CXR neg , D dimer 4000 , seen by ID and had 3 days of remdesivir --slightly hypotensive --was given iv fluids ---LEVD was negative for DVT --stable for dc home w home care
Pt reported 2-3 days p/being injected w/ Engerix_B pt exp a fever, pruritis & a fine reticular rash; 30APR92 still has rash & itching; MD thinks pt has Hep B; feels pt had serum sickness; dx condition as stills disease;
Information has been received from a mother concerning her 8 year old son who was vaccinated with a dose of MMR II. Subsequently the pt developed autism. Unspecified medical attention was sought. It was unknown if a prescription drug was required. The pt's autism persisted. It was noted that the pt had all of the required immunizations. It was also noted that the pt's brother, 3 years old, developed signs of autism following vaccinations with diphtheria toxoid/pertussis vaccine/tetanus toxoid and poliovuris vaccine inactivated. Upon internal review, autism was determined to be an other important medical event (OMIC). The reporter indicated that her other 6 year old son had autism after receiving all of the required immunizations (WAES0305USA02845). Additional info has been requested.
pt had unconsolable crying, irritability the day of vax extending for approx 24 hrs; pt had poor PO intake-lost 30 oz; a full r/o sepsis eval including spinal tap, blood & urine cx done all neg; pt hospitalized on ATB 48 hrs t99.9;
No adverse event; Dose administered after more than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     At the time of vaccination, patient has no medical history related to both Acute and Chronic illnesses.  Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose, Intramuscular route) on 22-Mar-2021, JANSSEN COVID-19 VACCINE (2nd dose) on 11-May-2021, Pfizer Vaccine (1st booster and Lot number:SM7553) on 27-May-2022. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE, JANSSEN COVID-19 VACCINE and Pfizer Vaccine. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) from 22-Nov-2022 to an unknown date for an unknown indication.   On 22-Nov-2022 at 7:45 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022 at 7:45 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post puncture).    Patient was under treatment for blood pressure but did not know name of medications. The vial size was 2.5 ml and individual vial. the vial was initially stored in the refrigerator on 21Nov2022 The vial was first punctured on 21Nov2022 8:00 am and stored post puncture at Room temperature. the vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8 degrees centigrade to 25 degrees centigrade to 46 to 77 degrees F) was approximately less than 24 hours.
Felt fine first few hours 9pm Fri felt headache went to bed early  Felt fine  12:10 midnight Monday sharp pains in chest took over counter advil and then took sleep aide- still had sharp pains 4:00am  really hard to breathe- started to drive self to ER- could not make it - half way called for ambulance Oxygen level 61 when EMS arrived In ER Chest xrays and mouth xrays show double clot in lungs In hospital with IV and breathing treatments til Wed.
At 1:00 I started with severe chills and then began throwing up.  Had chills and nausea for the next 24 hours with vomitting thru out.  Also have fluid in clavicle area which maybe inflammation from vaccine injection, not sure.