chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THE PATIENT WAS 15 YEARS OLD AT THE TIME AND SHOULD HAVE RECEIVED PFIZER AND NOT MODERNA.
Postural orthostatic tachycardia syndrome; report describes neuropathic symptoms/Neurological symptoms/Severe orthostatic tachycardia, paler, diarrhea, fluctuation in blood pressure; This is a literature report.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid -19" (unspecified if ongoing). The patient's family history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE Unknown manufacture), for Covid -19 Immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown"; NEUROLOGICAL SYMPTOM (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "report describes neuropathic symptoms/Neurological symptoms/Severe orthostatic tachycardia, paler, diarrhea, fluctuation in blood pressure". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Biopsy skin: normal; 17.2; Normal; 11.1, notes: wnl; 15, notes: wnl; Blood pressure diastolic: Unknown result; Blood pressure measurement: fluctuation; Blood pressure systolic: Unknown result; Heart rate: Unknown result; Immunohistochemistry: Unknown result; Autonomic testing: POTS; Unknown result; Normal; CSF pattern II OCB;negative autoimmune, notes: dysautonomia panel; negative; Unknown result; Magnetic resonance imaging: Not Done; Neurological examination: Normal; Respiratory rate: Unknown result; Valsalva maneuver: Unknown result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202200764439 Same article/ drug and different patient/event
Arm is sore. Within 45 minutes of getting shot my throat felt like it was very swollen
I noticed red splotches all over my face. Computer search made me believe it was Purpura. I sent photos to my doctor and he confirmed that it indeed appeared to be Purpura. It happened again two weeks later, to a lesser extent, when I had a strong sneezed. I don't know what brought on the first instance. I don't recall doing anything in particular that would cause that.
Mother is Hispanic and responded to the wrong patient's name. I had the information on another patient. When I asked her about his size she said the baby was being followed by doctor. I gave her the VIS and told her that since this was the babies second set of immunizations that he would have had these before. No adverse effects noted at this time. The infant was in the health department for two hours after receiving the immunizations.
a male adolescent experienced syncope; This spontaneous report was received from a pharmacy technician via a company representative, referring to an adolescent male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On an unknown date in 2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, exact dose, anatomical location, route of administration were not reported) for prophylaxis. After receiving the vaccine, he experienced syncope (the patient slumped over in chair). It was stated by the reporter that he did not need any intervention by staff. No treatment was given due to the adverse event. It was unknown if any lab diagnostics or tests were performed. The outcome of the event was reported as recovered.  Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event of syncope was considered to be medically significant.
Received second Varivax 6/26 developed typical vesicular rash on 7/10,  new lesions 7/11 and 7/12.
Fever day of and day after vaccines, rash -> E. multiforme developed 3 days after vaccines.
Myalgia beginning w/; 24 hrs- fatigue.  Panesthesia hands on 2/4/09.
Patient got the Pfizer vaccine 3 days earlier than the grace period for the second dose of Pfizer vaccine.
involving Tetanus Vaccine (Allergy); Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer) (under reference number: 2019221592).  This case involves adult patient of unknown demographics who experienced involving tetanus vaccine (allergy), while received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious involving tetanus vaccine (allergy) (allergy to vaccine) following the administration of TETANUS TOXOID.  No Lab data was reported.  Final diagnosis was involving tetanus vaccine (allergy).   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for involving tetanus vaccine (allergy).  Documents held by the sender: none.
pt reports p/each hep B vax has had a resp illness w/an onset of 3 days p/vax;each time pt saw pvt MD;6MAR96 pt devel lung infect w/ATB tx of Cefaclor;MD told pt it was not a rxn;pt feels it is a allergic rxn
Information has been received from a resident concerning a 73 year old male patient with no known drug allergies and with osteoarthritis in his left shoulder, degenerative joint disease, osteoarthritis of cervical region, aortic stenosis, hypertension, hyperlipidaemia and back pain, who on 28-OCT-2009 was vaccinated intramuscularly in the left deltoid with a 0.5ml dose of PNEUMOVAX (lot # 662268/1134Y). This was the first known dose of PNEUMOVAX for the patient. Concomitant therapy included trazodone HCl, EFFEXOR, LOVAZA, aspirin, vitamins (unspecified), cyanocobalamin, ubidicarenone, LIPITOR, COREG, UROXATRAL, PLAVIX and PERCOCET. On 28-OCT-2009 the patient developed Pseudo septic arthritis of the left shoulder after receiving PNEUMOVAX. As a result the patient was currently still in an unspecified hospital where he underwent shoulder surgery: open drainage; lots of pus but culture was negative. The date of admission was unknown. At the time of the report the patient had not recovered. The patient sought medical attention (office). The patient's septic arthritis was considered to be temporarily disabling and to be an other important medical event by the reporter (Intervention to prevent serious criteria: surgery). Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Aug2021 as dose 1, single (Lot number: FA7484), in right arm and on 24Aug2021 as dose 2, single (Lot number: FC3182) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Crohns w/resection (dormant for 14 yrs)" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: 04Jan2018; AHCC, start date: 14Jun2021; VITAMIN D [VITAMIN D NOS], start date: 03Jun2020; CLARITIN [CLARITHROMYCIN], start date: 01Apr2022, stop date: 05Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Pyrexia: 101.2; SARS-CoV-2 antibody test: Unknown results; Negative, notes: antigen negative; Positive, notes: Antigen pos. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: COVID 19 Treatment start date on 28Jul2022 and stop date on 02Aug2022 (Lot Number: GC0490). Other medication in 2weeks start date was 01Apr2022. Other medication in 2weeks stop date was 05Aug2022. Adverse event: Began Paxlovid Day 2 w/very mild symptoms; all gone by Day 5 (Day 3 of Pxlvd). By Day 7, antigen negative & Pxlvd completed. Day 10, rapid onset of moderate symptoms: very enlarged lymph nodes in neck and jaw, throat swelling, runny nose, tonsils so large I cant even drink, dizziness, bp fluctuations. Fever 101.2. Antigen pos. Known allergies was no.
At arm sore, tender on 10/6/08.  Had trouble sleeping on at side.  By mid morning 10/7/08 was having increase in pain + by 2:30 pm it was "excruciating" at times.  10/08/08 c/o arm being cold.
Large red swollen area at inj. site, hot to touch, 8cm x 10cm.
Pt reported feeling very weak, BP elevated 154/74, temp 99.1F, facial flushing , teeth chattering, HR increase to 105 per minute. Unable to work or stand. Pt sent home from work due to extreme weakness. Instructed to call physician from home.
Pt c/o headache, the began c/o sensitivity to light. On 1/22/09 went to have eyes checked retinas inflamed. Went to ophthalmologist retinas being treated. Then pressure went up, and had surgery on R eye 6/23/09.  7/7/09 Consultant records received DOS 2/4/09 to 6/2/09. Assessment: Retinal vasculitis and vitritis, pars planitis, increased ocular pressure. Patient presents with flashes left eye, black lines. Headaches during day, eyes light sensitive. Floaters right eye. 8/24/09 Received Ophtho medical records of 6/9/09-8/18/09. FINAL DX: Pars planitis right eye; increased intraocular pressure. Patient tx w/diuretic & drops.  IOP remained high, developed severe HE..  Surgery of trabeculectomy w/antimetabolites, right eye done 6/23/09.  continued to have pain & blurred vision post operatively.  Developed heavy feeling in right eye, increased floaters in left eye & hazy vision.    6/30/09 Received PCP & vaccine records of 1/20/2009-2/4/09. Records reveal patient experienced back ache, cervicalgia, HA.  Received depo-provera & vaccines.  Referred to retina specialist on 2/3 but no office note. Follow-up: Pt has had 2 surgeries on her right eye. She will have 1 more next month. Her right eye droops, blocking her vision, sensitive to light.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 17-FEB-2014, the patient was vaccinated with second dose of VARIVAX (dose unknown) from lot # H018451 with expiry date: 09-OCT-2014 which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
pt recv vax 23FEB99 & immediately devel a gen rash;the rash resolved w/in 20min w/o treatment;
Acute on chronic hypoxic respiratory failure due to COVID-19 pneumonia, possible superimposed community-acquired bacterial pneumonia with sepsis. * Not a* Not a candidate for remdesivir due to renal failure. Initiated on dexamethasone and given 1 dose of tocilizumab upon admission after reviewing with ID. Also initiated on levofloxacin for possible superimposed bacterial pneumonia. - On HFNC 25L 35% FIO2
shortness of breath No energy Fever 103 for two days, Tylenol didn?t work to break it Full body sweats. I had to change my bed sheets 3 times in four days  Body aches Sore in legs, neck and inside of my arms Dehydration   The inside of my left arm still hurts and throbs (not where I got the shot)
Starting 01/11 severe arm pain. Starting 01/12 rash from my ankles to knees , minimal on my arms. Rash doesn't itch and not sore.  Rash is tiny red spots. I feel fine.
I was exposed to a patient on 1/4/2022 that tested positive for covid on 1/6/2022. On 1/6/2022 I had a headache and a runny nose, which I assumed was due to lack to hydration and the cold weather. Once I learned the patient tested positive, I canceled my patients for the day and isolated. I developed a severe headache, fatigue, diarrhea, congestion and chills over the course of 5 days. The fatigue lasted 10-11 days.   I was tested three times for covid, 2  PCR and 1  rapid test, and all were negative. The flu and strep tests were also negative. Given my exposure and symptoms, and my partner who developed severe congestion and lost his sense of smell and taste, I did not see patients and isolated for 10 days. I fully recovered after two weeks.
Approx 2 - 3 min after giving HOV #2 vaccine in the left arm child states he could not move his left arm, left arm flaccid, after about 5 min child was able to move his arm.
2 HOURS AFTER VACCINE CHILLS, HEADACHE, CHEST PAIN, ABDOMINAL PAIN, VOMITED, FEVER. 2 DAYS AFTER FELT OK
general area around where the shot was given looked a little discolored; red swollen itchy bumps; it has been very painful; inside of my left arm broke out in a patch of red swollen itchy bumps; red swollen itchy bumps; red swollen itchy bumps; general area around where the shot was given looked a little discolored for some days and felt swore to the touch for some days; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:00 (age at vaccination: 57 Years) as DOSE 2, SINGLE for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included known allergies of BIAXON, and rest other history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously took bnt162b2 (Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in arm left on Mar2021 15:00 (age at vaccination: 57 Years) as DOSE 1, SINGLE for covid-19 immunisation. On 21Apr2021 16:00, the patient experienced general area around where the shot was given looked a little discolored, inside of my left arm broke out in a patch of red swollen itchy bumps, red swollen itchy bumps; and it had been very painful. Clinical course was as follow: the patient at first noticed the general area around where the shot was given looked a little discolored for some days and felt swore to the touch for some days. On 21Apr2021 (Wednesday), the patient noticed the inside of her left arm broke out in a patch of red swollen itchy bumps. She put hydrocortisone (therapeutic measures were taken for red itchy bumps and painful) on it, and it seemed to relieve the itching, it had been very painful, but the hydrocortisone seems to help. Still patchy and not completely clear yet. Reportedly, the case was non-serious. Outcome for all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Soreness,  redness Flu-like symptoms  (body aches, fatigue) Low grade fever- 100 degrees Muscle pain Headaches
Initial report was received from a healthcare provider on 29 September 2011. An 80-year-old male patient had received an intramuscular (IM) injection of FLUZONE High-Dose; lot number UH436AD in right arm on 29 September 2011. On the same day of the injection, the patient experienced shaking, chills, vomiting and arm soreness in right arm. No further information was available at the time of the report. The patient outcome was reported not recovered/not resolved. Documents held by sender: none.
day p/vax pt exp rash, induration erythematous plaque, warm. skin mild tender. f/u done swelling down.
4/26/19 Patient called stating arm sore. 4/27/19 Patient spoke with pharmacist stating seemed to be getting better, and would follow up with us if still an issue. 5/7/19 Patient stated still soreness in Right Deltoid at injection site and on range of motion moving arm upward to head at side of body.
caller got positive result of COVID 19 after first shot/tested positive; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown), via an unspecified route of administration on 03Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that at first he had no side effects. Then, last Saturday on 10Apr2021, he started getting a headache and a cough. Sunday on 11Apr2021, it got worse. Monday on 12Apr2021 he had a fever. On 13Apr2021, Tuesday he was getting ready to go to work but he tested positive. He was still going through it but he's wondering if he can get the second dose. He also mentioned that they told to him to isolate for 10 days from the time he showed symptoms, then he can go get tested. He has to get 2 negative tests before going back to work. Patient got positive result of COVID 19 after first shot. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
High Fever of 104.1-103.8 for three consecutive days. Body aches, chills, joint pain, severe headaches and swelling of glands.
Pt. mom called stating that pt. has an all over "yucky" feeling since getting vaccines. She got shots on 1-8-18, took a nap when she got home. Mom states napping is not unusual. When she awoke, she stated feeling of body aches, hot and cold alternating and headache. Mom said that she took her temperature twice and did not have a fever. She spoke to her doctor's office they said it was from the vaccines and that she should be seen when she has a sore neck. I encouraged mom to have her seen by the doctor to evaluated for other illness as well as possible vaccine reaction. Mom was very thankful for the conversation.
Painful with episodes of extreme dizzyness.; Menorrhagia and irregular mensturation lasting 8 days or more.; Menorrhagia and irregular mensturation lasting 8 days or more.; Painful with episodes of extreme dizzyness.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: May2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right), administration date: May2021, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), PAIN (non-serious), outcome "recovered with sequelae" and all described as "Painful with episodes of extreme dizzyness."; HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION IRREGULAR (non-serious), outcome "recovered with sequelae" and all described as "Menorrhagia and irregular mensturation lasting 8 days or more.". The events "painful with episodes of extreme dizzyness.", "menorrhagia and irregular mensturation lasting 8 days or more.", "menorrhagia and irregular mensturation lasting 8 days or more." and "painful with episodes of extreme dizzyness." were evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness, heavy menstrual bleeding, menstruation irregular, pain.  Additional information: The patient did not received any other vaccine within four weeks. The patient was recovered with lasting effects and was seeking gynaecological treatment as result. Covid tested post vaccination: unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
irregularity as missed periods entirely, they didn't come.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 at 07:45 as dose 2, single (Lot number: EN5318, Expiration Date: 31May2021) at the age of 41 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, NDC: Unknown , LOT: EL1283, EXP: 30Apr2021, Dose and Route: Unknown , Time: in the morning, guessing between 8:00AM-8:30AM), administration date: 26Jan2021, when the patient was 41-year-old, for COVID-19 Immunization, reaction(s): "menstrual cycle irregularities after receiving the COVID-19 vaccine and the booster".  The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "irregularity as missed periods entirely, they didn't come.". The event "irregularity as missed periods entirely, they didn't come." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstruation irregular.
I spoke to patient. She stated she got "COVID-19 arm" with her primary series of Moderna. She knew she didn't get Moderna because she did not get "COVID-19 arm" this time.
?COVID arm? intense itching, hard area around injection. Started 7days after shot. No other symptoms