chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date the patients might were vaccinated with a dose of ZOSTAVAX (lot # not reported) stored as high as 9F for about 2 months. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from same source. Additional information has been requested.
Case number# PHHY2015US016295, is an initial report received from a physician on 05 Feb 2015. This report refers to a 74 year old male patient. Medical History was not reported. Concurrent conditions included impaired fasting glucose, hypothyroidism, gastrooesophageal reflux disease, osteopenia, seasonal allergy and erectile dysfunction. This polymedicated patient received DIOVAN for the treatment of hypertension from an unknown date in 2009 at a dose of 320 mg, QD (oral). The patient received influenza vaccine on 23 Sep 2014 at a dose of 1 DF single (intramuscular). This patient also received pneumococcal vaccine on 23 Sep 2014 at an unknown dose (blinded). On 23 Sep 2014, in the evening the patient was walking across the room, he collapsed, fell backwards and struck his head he was awakened less than a minute by his wife and rescue was called, then he was transferred to emergency room (hospitalized on 24 Sep 2014), full work up done, including cardiac work up with negative serial enzymes x3. ECG (electrocardiogram) was normal and lab results were unremarkable. Chest X ray showed no acute cardio pulmonary disease, Echocardiogram showed ejection fraction of 60-65%. CT (computerized tomogram) head was normal. Final diagnosis was vasovagal syncope. On 25 Sep 2014, the patient was hydrated and discharged. No medication changes were made. In response to the events DIOVAN was temporarily withdrawn on an unknown date in 2014. The event stopped on an unknown date in 2014. The event did not reoccur and on an unknown date in 2014, the patient resumed the treatment with DIOVAN. On 22 Oct 2014 an additional dose of blinded therapy was administered at 1DF single dose. Outcome of the event syncope was reported as complete recovery on 25 Sep 2014. Causality of the event syncope was reported as related (suspected) to DIOVAN. Outcome and causality of the event fall was not reported.
Fever of 100.5 R x 4 hrs p/DTP given; fever < 100.5 R x 2 days;
contracted Covid-19; contracted Covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "contracted Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: contracted covid-19, notes: Caller states they have contracted Covid-19 and have now fully recovered. Clinical course: The reporter had inquired about two kids, who were vaccinated with the pediatric formulation orange cap Pfizer BioNTech Covid-19 vaccine 3 weeks ago. The reporter stated that they have had contracted Covid-19 and have now fully recovered. Reporter would like to know if the second dose of the pediatric formulation Covid-19 vaccine should be administered on schedule or if the second dose should be delayed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19. 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
Arm soreness at injection site for first 48 hours after shot. 1 week after shot experienced 12 hours of chills and low grade fever. 9 days after shot developed swollen lymph node at collar bone on left side (same side as shot). Lymph a bit painful and swollen lymph node has lasted 1 week so far.
was laying down because was not feeling well/ felt sick; all of a sudden got dizzy/felt like fainting; heart started racing; anxious; could not concentrate; felt like chest hurts; head feels funny; difficult sleeping; felt a lot of fear that something was wrong; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0175) dose 1 via an unspecified route of administration, administered in left arm on 23Apr2021 as FIRST DOSE, SINGLE for COVID-19 immunisation. Medical history included diagnosed with COVID-19 and allergies was none. The patient's concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On Saturday 01May2021, the patient was laying down because she was not feeling well, all of a sudden she got dizzy and her heart started racing and she felt like fainting. Since then every day had been horrible she felt dizzy, she felt very anxious, she could not concentrate, she felt like her chest hurts and her head feels funny. She had difficult sleeping and she felt a lot of fear that something was wrong with her. She did not feel like herself anymore. The adverse events result in doctor or other healthcare professional office/clinic visit and visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included TSH, CBC, CMP, Thyroid and Vitamin D: unknown in 2021, body height: 5'5 in 2021 not clarified appropriately. Therapeutic measures were taken as a result of events and treatment with Sertraline 50 mg. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information was expected.
Burning on administration, afterwards severe pain in upper arm and myalgia in arms, back and legs. Continues over 48 hours after administration.
Rash around entire neck; Swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on left arm on 06Jan2021 12:00 at a single dose for Covid-19 immunization. Medical history included scoliosis, sport-induced asthma, and seasonal allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ibuprofen (IBUPROFEN), and meclozine hydrochloride (BONINE). The patient experienced rash around entire neck and swollen lymph nodes, both on 09Jan2021 06:00. No treatment received. The events were reported as non-serious. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested for Covid-19 since the vaccination. Outcome of the event was not recovered.    No follow-up activities are needed. No further information is expected.
Face and eye swelling 10 hrs post vaccine injection; Face and eye swelling 10 hrs post vaccine injection; Describes feeling a "chemical burn" in her throat; Her ears are plugged up; Cough; Feels dizzy; Feels itchy every evening for the past 2 weeks; This is a spontaneous report from a 70-year-old female contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced face and eye swelling 10 hours (post vaccine injection). Describes feeling a "chemical burn" in her throat. Her ears are plugged up and has similar reaction to what she had experienced with penicillin. Currently has a cough and feels dizzy. Patient was given 50 milligrams Benadryl as well as steroids. Feels itchy every evening for the past 2 weeks. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
site of injection is sorel; Arm is Swelling; Under Arm is Painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (site of injection is sore), VACCINATION SITE LYMPHADENOPATHY (Arm is Swelling) and PAIN IN EXTREMITY (Under Arm is Painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M2A and 013M2A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (site of injection is sorel), VACCINATION SITE LYMPHADENOPATHY (Arm is Swelling) and PAIN IN EXTREMITY (Under Arm is Painful). At the time of the report, VACCINATION SITE PAIN (site of injection is sorel), VACCINATION SITE LYMPHADENOPATHY (Arm is Swelling) and PAIN IN EXTREMITY (Under Arm is Painful) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment includes Tylenol ,Benadryl cream.
Mom states patient was fine right after shot #1, but felt faint, looked pale on way out of office - came back to exam room and laid down x 20 minutes then was fine. Mom reports this today when returning for shot #2.
Information has been received from a consumer concerning a 4 year old male patient's with a history of "eosinophic" colitis and "rash from antibiotics" who on 17-Jan-2002 was vaccinated SC in the left quadricep with a first dose of mumps virus vaccine live (lot#638062/1725K).  There was no concomitant medication and no illness at the time of vaccination.  It was reported that the patient experienced a "vaccination failure".  A titer was done on 07-Jun-2005.  Follow up information from the reporter indicated that the patient had no antibodies for mumps when blood was drawn to check for antibodies "on 8/05".  He did show antibodies to rubella and measles.  It was noted that the vaccines were given separately.  The patient status was reported as not recovered.  There was no product quality complaint involved.  Additional information is not expected.
I have long COVID even though I am vaccinated 3 times; I have long COVID even though I am vaccinated 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 58--old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart condition" (unspecified if ongoing), notes: So I have, and a heart, condition. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have long COVID even though I am vaccinated 3 times".   Clinical course: During the call, the patient stated that patient was sick, became disabled. Patient got Covid and had long Covid even though vaccinated 3 times. Patient was supposed to get vaccinated, get fourth shot yesterday for second booster and patient had a flare up again. So, it gave all kinds of weird symptoms when had long Covid. Patient petrified of it that had long Covid because just a couple of days ago on the news they were talking about long Covid and they gave another slew of symptoms that are associated with long Covid. If patient needed another thing to make scared to death about dementia. As needed anything else to tell, patient could potentially get dementia. The fear was real and then they said the long Covid was showing dementia, brain (inaudible) Those kinds of things. If patient hadn't been vaccinated 3 times, would have died from it for sure because patient had (inaudible) that are auto-immune related. Patient had a heart condition and so had no immune system virtually. Patient got it in the hospital, still got it (Covid).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200051653 same patient/event/drug, different dose;US-PFIZER INC-PV202200051654 same patient/event/drug, different dose;US-PFIZER INC-PV202200051655 same patient/event/drug, different dose;
Within minutes of receiving the vaccine, I developed a cough and shortness of breath- told the nurses at clinic. I was sitting down and they put them me on the ground. My throat became itchy and my airway began closing. The nurses noted I developed hives on my chest and stomach.  A nurse gave me IM Epinephrine in my left thigh. It didn't not work for a couple of minutes (4-5 mins), so the nurses double checked the injection site to make sure it was administered (it was), as I didn't feel the injection. It did work after 4-5 minutes, and when EMS picked me up, I was still having throat itchiness, but improved.  I was taken to the ER via ambulance. My heart rate was in the 120-130s due to Epi. I did develop rebound shortness of breath, throat itchiness and a feeling of my throat closing again ~20 minutes later when I was waiting in the ER. The EMT told the triage RN and ~15 minutes later, I received IV Benadryl and IV Solumedrol.   I was told to take PO Benadryl or Xyxal for 48 hrs to help decrease inflammation. I took Xyxal mostly, for ~72 hrs, to be cautious. ............a week later I developed Shortness of breath, throat tightness and itchyness in a garden while holding a Maple Leaf. I was able to take liquid Benadryl, but had my Epi pen ready. My reaction to mosquito bites has worsened since, where the site will swell into a white hive, and I'll need to take Hydrocortisone to treat it. I've never had allergies to medications, leaves, and only mild itchiness at   mosquito bite sites.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 75 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Yes, vaccine was received and other medication in 2 weeks. Atorvastatin was given as other medication in 2 weeks. No, known allergies.  No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed practical nurse concerning a 12 year old female who on 12-JAN-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM. On 12-MAR-2007, the patient was vaccinated with the second dose of Gardasil. Subsequently, on an unspecified date, the patient missed her menstrual cycle after receiving her first dose of Gardasil. Subsequently in February, the patient's menstrual cycle returned to normal and the patient recovered from the event. Additional information has been requested.
circular red spot on the opposite arm of the injection; white dot on the opposite arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (circular red spot on the opposite arm of the injection) and PAPULE (white dot on the opposite arm of the injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical History was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ERYTHEMA (circular red spot on the opposite arm of the injection) and PAPULE (white dot on the opposite arm of the injection). At the time of the report, ERYTHEMA (circular red spot on the opposite arm of the injection) and PAPULE (white dot on the opposite arm of the injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
Pink area to left upper thigh with some swelling. No induration, no warm to touch. Advised Tylenol, cool packs to thigh
Accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effects noted;
1st dose recd 1/6 and broke out on foot it looked like small cuts but the capillaries and it spread to the let then to the opposite foot and leg. 3 days later a big rash broke out on shoulders and back of hands. 2nd dose, the same thing happened but it had a mark where it stopped then jumped to the arms and to the back which felt like my nerves in my body was being attacked by fire ants. They did a biopsy on the area on right leg and I feel like ants are crawling all over me and biting. on my back there's no redness but it feels like ants biting and itching. the doctor's stated there's no bacterial or fungal infection. This attack is from the knee down both arms and back only and the doctor had no other treatment for it other than cortisone cream and nothing seems to stop it.
Admit w uncomplicated actue appendicitis. Opted for non-operative management due to COVID+ (asymptomatic). Uneventful recovery. Pain free, nml WBC at time of discharge. Home on 5 days oral abx
Client anxious about receiving first dose. Said he checked with his doctor as he has multiple antibiotic allergies. His doctor told him to get a COVID vaccine.  He received the vaccine and was asked to wait 30 minutes. After a 15 minute wait, he stated he felt chest tightness, swelling in his eyes, face and neck.  His blood pressure was elevated at 180/100 and his heart rate was 150.  He felt hot/cold and felt he was going to pass out.  Cool cloth to forehead and comfort position.  after 5 minutes his blood pressure back to 140/80 and pulse down to 100.  He continued to state his face/neck and chest were swelling and felt tight.  He continued to talk without lack of oxygen.  He asked an ambulance be called.  He was taken to a local hospital for evaluation and was released home.  No medications were given and no face/neck swelling were noted by healthcare workers.  Family states he is home and doing well.
Pt recv vax on 11/5/98; on same day pt exp fever, paleness, chills, numb lips&gums, achy, headache, cough, sore throat, shortness of breath, shaky x 2-3 day
Small reddened area around injection site in the morning after injection. Later in the day area around injections site became darker red 8cmx10cm area. Slight swelling. Warm.
Pt passed out + was unconscious after the shot was administered. She appeared short of breath and her face ,color was very pale . she was not moving when we tried to consider putting her  on floor. She seemed to have rigid body & seizure like.  I administered 2 doses of epinephrine & a few min.  after second dose pt became conscious & paramedics took her to Hospital. *  Patient was very nervous about receiving her vaccination & brought her boy friend along for support. She stated she was very nervous, as she was planning to  receive a Moderna vaccine after the Flucelvax vaccine.  Sine she had the reaction to Flucelvax, she never received the Moderna vaccine that day.  *Patient urinated during the time she was unconscious.
Pt called with complaints of jaw pain the day after TDAP administered. "C/o bilateral jaw pain right side is more tender than left but both hurt. Hurts to close jaw all the way down. No swelling, no fever, nausea or vomiting." 2 days later called with follow up - "doing fine". Pt. called our office with complaint the day after vaccine was administered.
3/31 stroke like symptoms ED with admission for testing  4/20 stroke like symptoms ED with admission for testing  4/27 seizure  4/28 seizure during MRV confirmed no stroke  5/2 15 seizures ED visit to stop seizure activity 5/3 19 seizures, admission for LP and EEG study  5/4 4 seizures discharged, tests inconclusive  5/5 2 seizures 5/6 2 seizures All are accompanied by severe headache, blurred vision, confusion
not have any effects to the vaccine, other than a sore arm.; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 07Mar2021, the patient experienced not have any effects to the vaccine, other than a sore arm. The outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vasovagal reaction about 1-2 minutes after giving vaccine. Pt stumbled and fell. She did not hit her head on anything and was not injured. in less than a min., Pt opened her eyes and sat up but did not know that she passed out and fell. She sat in a chair for another 15 minutes (checked on her 3 more times) and she was okay.
Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours,  moderate relief with Tylenol.  Joint pain for 72  hours with mild relief with Tylenol. Loss of appetite for 24 hours.  Left deep armpit pain for 4 days, just subsiding but still evident.  Left deltoid injection site warm and red with redness tripling  in size  over 3 days (covered entire deltoid region.) Site remains warm and red since initial injection but seems to be improving today (day 4 post vaccine)