chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's neck started to bother her; Patient experiencinced achiness; Patient's arms were aching and were bothering her for a couple of months; Flu-like symptoms; Pin prickly sensation in her spine; This is spontaneous case reported by consumer to Agency (reference number: SEQ19-06567) and initially received on 12-Nov-2019, concerning a 50-year-old female patient.  The patient's relevant medical history included previous stroke and mild cerebral palsy. The patient's concomitant medication was not provided.  On 17-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, anatomical location: left deltoid, route of administration, expiry date and batch number: not reported] for prevention of seasonal influenza.  On the same day, the patient was administered unspecified pneumonia shot (anatomical location: left arm, brand name, dose, route of administration, batch number and expiry date: not reported) for an unknown indication.  On an unspecified date, shortly after vaccination with both vaccines, patient developed pin prickly sensation in her spine, her neck started to bother her, she experienced achiness and flu-like symptoms. Her arms were aching and were bother her for a couple of months after vaccination, but it eventually resolved.  At the time of initial report, the outcome of the event aching arms were recovered, while the outcome of all other events was not reported.  This case was assessed as non-serious.  The reporter did not provided causality assessment.  This case is linked to case 201906048 due to the same patient.  Company Comment: The patient experienced musculoskeletal discomfort, pain, pain in extremity, influenza like illness and paraesthesia erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. Medical history of stroke and mild cerebral palsy may have contributed to development of the events.  No concomitant medications were provided. Considering all the above mentioned, causality between suspect products and the events is assessed as possibly related.; Sender's Comments: The patient experienced musculoskeletal discomfort, pain, pain in extremity, influenza like illness and paraesthesia erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. Medical history of stroke and mild cerebral palsy may have contributed to development of the events.  No concomitant medications were provided. Considering all the above mentioned, causality between suspect products and the events is assessed as possibly related.
Generalized, diffuse morbilliform rash that started on the face and spread over time. Per parents, patient was having shortness of breath following 12 month vaccines. Patient presented with faint wheezes on day of the appointment.
Ringing in ears, throbbing headache, sore/tender right arm, sore neck muscles, fatigued.
I immediately could taste it because they injected it in my blood. I am exhausted. My thinking and cognition is messed up. My hands and feet are always numb. My teeth are now moving. My period cycle is off. I am exhausted. i feel like this shot gave me a serious autoimmune disorder. I never know what day it is. I feel so stupid and I was always the smart and gifted one. Now I can barely do my job. I can't even focus on a book I can't see my chest hurts all the time. I would rather my heart explode than feel as stupid as I do
patient received a pediatric dose / on July 7th, 2021; patient received a pediatric dose / on July 7th, 2021; patient received a pediatric dose / on July 7th, 2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 25-year-old female patient who received HAV (Havrix 360 Junior) (batch number N592C, expiry date 12th June 2022) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Havrix 360 Junior. On 7th July 2021, unknown after receiving Havrix 360 Junior, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and underdose were unknown.  Additional details were reported as follows: The adult female patient received pediatric dose of Havrix. Health care professional called and asked if the patient can receive another pediatric dose of havrix to complete adult dose. The patient didn't received till second dose of havrix. Consented to follow up.
Immediately after vaccination @11: 14, pt reported flushing/sweating, dizziness, blurry vision and lightheadedness. Vitals: 123/75, 71, 20 Pt stable and released form the vaccination site @12:00.
6/5/14: pulling at her ears and took to UC Monday evening -Rx Azithromycin for otitis. Yesterday started with some dark bruising on her arms 1-1 1/2" and pinkie size bruising on legs, thighs, and buttocks. Had nosebleed this am which she has never had in the past. More bruising with light touching. GP had her in stroller and she hit the side of her head and immediately bruised- above eye and now on her tongue will f/u with hospital. 6/6/14: admitted to Hematology unit at hospital - platelet count 2 (120-150) had difficulty with IV line and she was screaming/started to bleed from her ears, gave IV immunoglobulins for 6 1/2 hrs last pm, no apparent side effects at this time, vitals every 15 min thru night - scheduled at 2pm for bone marrow biopsy - will have preliminary results later today.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt says she developed a softbaal sized lamp like swelling over the left arm where the vaccine was place
Patient was given shingles vaccine 8/19/13. She called clinic to report site symptoms - red, swollen, warm, tender - instructed pt to take BENADRYL, and to follow up if worsens or does not improve.
Kidney stones, 2 total, first the day after 2nd vaccination, 2nd the following day. Stones were moderate, blocking urine flow for about 30 minutes but passing with pain and very heavy bright blood. Self-treated with high fluid intake, blood dissipated reasonably. No recurrence. Also had a more usual and expected 2nd dose fatigue for several days.  Kidney stone history - passed a tiny tiny stone some 5 years before, with brief sting and trace blood; microscopic analysis by my doctor confirmed trace stones; scan indicated no significant problem. Reduced my tea intake.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 ml (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Saturday 6/18/205 site became red, swollen, and warm to the touch - compresses were used
on day 7 during the day my arm start itching around injection site and area around started swelling. Today (day 8) area is more swollen but doesn't really itch.
This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-MAR-2017, the patient was vaccinated with the improperly stored (between 6 and 14 degrees Fahrenheit for 30 minutes) dose of VARIVAX (for prophylaxis, lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion were reported. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009837:
MMRV and Hepatitis A previously given on 2/22/23 when child was brought in by mother of child.  On 3/11/23 Father of child brought in child back to clinic for second dose of flu vaccine and was not aware that patient previously received MMRV and Hepatitis A and these immunizations were repeated.  Child received MMRV and Hep A on 2/22/23 and again on 3/11/23  There was no adverse reaction reported as of yet
VACCINE INDUCED THROMBOTIC THROMBOCYTOPENIA; PULMONARY EMBOLISM; CEREBRAL VENOUS SINUS THROMBOSIS; This spontaneous report was received from literature:  of Ad26.COV2.S-associated VITT and specific detection of VITT antibodies. Journal of Hematology.  This report concerned a 51 year old female. The objective of this study was to assess vaccine induced immune thrombotic thrombocytopenia (VITT) antibody persistence using currently available functional and antigen-based assays and to develop new laboratory tools for the specific detection of VITT that would allow its differentiation from classical and spontaneous HIT (Heparin-induced thrombocytopenia). The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after 7 days of vaccination , the patient experienced vaccine induced thrombotic thrombocytopenia, pulmonary embolism, and cerebral venous sinus thrombosis. The patient was hospitalized on an unspecified date. Number of days of hospitalization were not reported.  Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not Reported, PF4 Polyanion Enzyme Linked Immunosorbent Assays (ELISA) was positive (there were persistent anti-PF4 antibodies for 6 months during follow ups), Fibrin D dimer was greater than 20, 000 ng/mL (elevated), Platelet count 55000 /uL, and Serotonin release assay result was not reported.  Treatment medications during episode included: high dose intravenous immunoglobulin G, argatroban, and prednisone. The subsequent treatment was apixaban. The patient was alive as on report time.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, cerebral venous sinus thrombosis and vaccine induced thrombotic thrombocytopenia was not reported. The authors emphasized that the associated VITT antibodies persisted for greater than 5 months in platelet factor 4 (PF4) polyanion enzyme linked immunosorbent assays (ELISA) while the PEA became negative earlier. Thus, it was concluded that the patients with VITT demonstrate long term ELISA positivity, although functional assays become seronegative earlier during the course of recovery. The data suggested that the un-complexed PF4 ELISA is sensitive and significantly more specific for the detection of VITT than currently available tests. This report was serious (Hospitalization Caused / Prolonged). This case, from the same literature article is linked to 20220237634, 20210448310, 20210444498, 20210415297, 20220249472, 20220249417, 20220249430 and 20220249503.; Sender's Comments: V0: 20220249398- COVID-19 VACCINE AD26.COV2.S- vaccine induced thrombotic thrombocytopenia,  pulmonary embolism, cerebral venous sinus thrombosis. This event(s) is labeled per RA and is therefore considered potentially related.
p/recvd inject pt immed c/o feeling sick, nauseated, hot sweats then cold sweats, dizziness; felt like couldn't hear; never lost consciousness;
Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficulty walking , skin self like bad sunburn when touched. lasted approximately 36 hrs.  For approx 12 more hrs moderate symptoms, then 24hrs minor symptoms.  Started on Tuesday night resolved by Saturday morning.
Patient became unresponsive and passed out on the floor. Mother laid her down on the floor, Could not determine between fainting incident or allergic reaction, therefore epi-pen 0.3mg was administered in the left thigh. Patient became aware, but groggy after about 30 seconds following the epi-pen administration. She continued to feel groggy for the next 10 to 15 minutes, we provided her with water, an ice pack, and she laid down. EMS arrived and completed an assessment. They determined that the correct action was taken and the patient was fine. She was monitored for 30 minutes following the incident. She left after the 30 minute waiting period. Total time taken was 1 hour from time of injection.
He was recently diagnosed with COVID-19 with a positive test on 12/30 and symptoms beginning on 12/28/2021. He reports cough that is nonproductive, subjective fevers without chills, nausea without vomiting and diffuse myalgias.  In the ED his 02 sat was 68% on RA. He was placed on HFNC 15 LPM.  Cause of death: Acute Hypoxic Respiratory Failure d/t Covid 19 PNA.  Secondary diagnosis  septic shock due to pseudomonas, acute renal failure, acute liver failure, recent chemotherapy for stage IV colon cancer with liver metastasis.
chills, upset stomach Patient took Tylenol with minimal effect. Recommended Mylanta for upset stomach No f/u due to no answer and unable to leave voice mail (not set up) x 2 (4/30 and 5/2/2021)
Patient had swelling and a bruise 1 week after injection, along with soreness. Injection site was IM Deltoid.
Until now headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jul2021 17:45 (Lot number: EWO196) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Chronic sinusitis" (unspecified if ongoing); "known allergies: Drug" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies: Codeine". The following information was reported: HEADACHE (non-serious) with onset 23Jul2021 12:00, outcome "not recovered", described as "Until now headache". Therapeutic measures were not taken as a result of headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19  Follow-up attempts are completed. No further information is expected.
Large red circle around the site. Arm very sore and itchy. Taking antihistamine reduced symptoms. Circle about 4 inches in diameter.
Pt started feeling shortness of breath and chest tightness. Was give zyrtec, epipen 0.3 mg, and albuterol inhaler. Pt then reported feeling "phlegmy" and was then transported by EMS.
1/11@2200 soreness at injection site. 1/12@2045 aching in both feet, left ankle, joints of right fingers, mod back and thigh pain - all resolved with acetaminophen. 1/17@0100 severe lower back pain.  1/17@1300 pins and needles in bilateral feet that were progressively uncomfortable. 1/18-1/19 severe bilateral foot pain, burning, pins and needles. painful ambulation. Not relieved with any over the counter medications. nausea and retching noted that day.  Mild dizziness. Pins and needles progressed up to thighs. 1/20 seen in Emergency Department, neurology consulted. Question of vs vaccine reaction. However discharged home. Symptoms started to decline on 1/21 with less pain and pins and needles. 1/21 minimal pins and needles but muscle cramps in right lower leg and foot  more than left leg.
pt recv vax in am. Mother called in pm. Child crying uncontrollably, leg very red, swollen, tender. Instructed to bring child in to MD. No fever noted, Recv ice, Tylenol, observe;
Took 1st oral typhoid vaccine on May 17, 2012 within 20 minutes his chest way heavy pressure on it; his throat was tight he had a tingling sensation in arms & legs & vision was blurry - last 2 hrs then he was OK. After taking 2nd oral typhoid on 5/19/12 he had the same symptoms within 20 minutes & it lasted 4-5 hrs.
Rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: RASH (non-serious), outcome "unknown", described as "Rashes". The event "rashes" required physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Reporter stated that she has misplaced questionnaire but want to let them know that a number of young women that she knew have had a similar experience with rashes like her. Finally a dermatologist (3rd on, she went to) had her take Pepcid which helped antihistamines did not work at all and caused weight gain for her and others. Anecdotally, this seems to be happening to young women unfortunately. She have been advised by a Dr not to take the most recent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10 minutes after vaccine patient complained of dizziness and feeling warm. Pt was shopping store when this occurred. I advised her to be seated and checked her BP (140/82 Pulse: 65). Husband came to pick her up.
Nausea, Appetite Loss,  Diarrhea, Headaches, Injection Site Pain, warmth and Redness, Muscle aches, Body Pain, Restlessness, Fatigue, Chills, Fever
Grand Mal seizure.  Had CT scan, MRI and EEG.  None of these showed any reason for the seizure.  Seizure was approximately 6 weeks after 2nd vaccine.
Information has been received from a RN concerning a 63 yr old male with a history of pneumonia last year. On an unspecified date, the pt was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). Concomitant suspect therapy included an unspecified influenza virus vaccine administered into the opposite arm. On an unspecified date, the pt developed redness, swelling, and tenderness up to the shoulder for several days. The pt sought unspecified medical attention. It was reported that the events resolved itself without treatment. At the time of the report, the pt had recovered from the events (date unk). Additional information has been requested.
Patient is developing shingles like symptoms on face and neck on same side of body that vaccine was given.
I don't know if it done something to my brain; had a stroke; I had a pain start in my temple go through to the other side of my head; I could not see; I was reading something on a computer and my vision I could not read what was on the screen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FF2583) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Rosuvastatin, notes: 20 milligrams, a statin and a low dose Aspirin. Vaccination history included: BNT162b2 (Dose 1, single Lot:EN6204, Patient had the first two Pfizer shot without any problem what so ever), administration date: 24Mar2021, when the patient was 84-year-old, for COVID-19 Immunization, reaction(s): "No adverse effect"; BNT162b2 (Dose 2, single, Lot: EW0162, Patient had the first two Pfizer shot without any problem what so ever), administration date: 14Apr2021, when the patient was 84-year-old, for COVID-19 Immunization, reaction(s): "No adverse effect"; Shingles shot (year and half ago patient had the shingles shot). The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset Oct2021, outcome "recovered", described as "I could not see; I was reading something on a computer and my vision I could not read what was on the screen"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "I had a pain start in my temple go through to the other side of my head"; CEREBROVASCULAR ACCIDENT (medically significant) with onset Oct2021, outcome "unknown", described as "had a stroke"; CEREBRAL DISORDER (non-serious), outcome "unknown", described as "I don't know if it done something to my brain". Therapeutic measures were not taken as a result of cerebrovascular accident, headache, visual impairment, cerebral disorder. Clinical course: The patient had no reaction with first or the second Pfizer shot but with the third one 48 hours after patient had the shot patient was sitting at the counter patient had a pain start in her temple go through to the other side of her head and patient could not see. Patient was reading something on a computer and her vision and could not read what was on the screen. It lasted all that long patient walked over to sit on the couch saying to herself what in the world just happening to her and then it went away.   Follow-up attempts are completed. No further information is expected.
Information has been received from a licensed practical nurse concerning a 15 y/o female who on 22Aug03 was vaccinated with a dose of varicella virus vaccine live. On 26Aug03 the pt went to the ER because of nausea and vomiting. The ER discovered that the pt was pregnant. The pt's LMP was 15Jul03. No prescription drug or treatment was required. No product quality complaint was involved. Additional information has been requested.
Pt received PNA vaccine 11/05/13 at 5:20 pm. Two hours later developed swelling, redness and warmth. Presented to practice on 11/06/13 at 11 am with area 21 cm x 12 cm of erythema, edema and warmth. Unable to move arm. Initially started on abx for concern for cellulitis, but then discontinued on 11-07-13.
10 minutes after receiving her booster dose, pt started feeling very nauseous and dizzy. Father came to our counter to check in with me and I went out to check on her. Pt had no SOB, WZ, no tightness in chest or throat, no sweating -- just reported feeling dizzy, nauseous and that she had thrown up in the store's bathroom. She was visibly pale and shaky. Before giving her vaccine, I checked how she had tolerated her first two doses and she reported feeling sick enough to go home the next day after her second dose, but didn't report nausea and dizziness to this extent.