chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Malaise, nausea, palpitations, tacchycardia and shortness of breath with exertion.  Symptoms lasted 2 weeks.  Patient did not seek medical advice
S/S:  Fever of 104 in evening after vaccine x3days; RX:  Tylenol followed by Levaquin 700mg po qd x5days followed by Cefuroxime 500mg po qd x10days. S/S:  Lung congestion and pleural rub; RX: Chest xray. S/S:  eye drainage x 2 days; RX:  antibiotic eye drops.
Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough and chest tightness continues.
I have been feeling shortness of breath and a frequent slow heart rate as low as 38-40 per minute when resting.
Vaccine administered 4/23/12. Mother called 4/24/12 to clinic reporting fever of 100.4 axillary, child fell down stairs - was not injured - body shaky for 30 seconds - pt has history of febrile seizures. No other symptoms.
Nasal Congestion, pressure, closed my abilities to breath with my nose, it took 2 weeks. I tried nasal spray & a Neti treatment.
pt recv vax;exp fever; on 4jun96 exp a rash w/ lesions on wrist, upper leg and near armpit;
28nov89 pt vax hepta B. pt ex pain at inject site. 28dec89 pt vax 2nd hepta B. pt ex prolonged pain and tenderness at injec site which lasted 2 days to 1 week. pt recovered
Case previously recorded as MA2009-4323. Initial case report received from a health case professional via agency, on 11 NOV 2009. A male patient born on 22 July 2007 was vaccinated with 0.5 mL once of FLUVIRIN (batch no. 102125P1) i.m. on 11 NOV 2009. No adverse events were reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Administration to a child younger than 4 years is unexpected after vaccination with FLUVIRIN. No change in benefit-risk-ratio. No measures are necessary. Agency reference no.: NA09-007978.
Large red area, sensitive to touch, extremely sensitive and  itchy and swollen.  At day 10 after vaccine ,large red area turned into a red rash.  Swelling went down at day 17, after vaccine.  Applied ice to area  to help relieve swelling an itching.  At day 19 symptoms subsided.
1 day following administration of FLUARIX QUADRIVALENT vaccine, developed third nerve palsy left eye - transient.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. FLUMIST was given intra-nasally. The product expired on 04-Mar-2012. On 07-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the events is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 17-Apr-2012: Suspect drug information and the reporter stated that the patient did not experience any late occurring adverse events.
false positive syphilis test; Initial information received on 21-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 49 years old male patient who had false positive syphilis test after receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine.  The patient's past vaccination(s) included FLUARIX. The patient's past medical history, medical treatment(s) and family history were not provided.   On 16-Jun-2022, the patient received 0.5ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot U7283AA; strength and expiry date not reported) via intramuscular route in the left arm for Immunization. Patient states that he received a Sanofi Tdap vaccination on 16-Jun-2022 from his doctor and was not certain of the brand name of the vaccine.  On 04-Jul-2022 the patient states that when he attempted to donate blood and he received false positive syphilis test (treponema test false positive) (latency:18 days). Patient states that this also happened to him approximately 2 years ago after he received a FLUARIX vaccine from GSK and received a false positive syphilis test when attempting to donate blood. Patient asked if there was any way to compare these two vaccines and was any information available regarding the Sanofi Tdap vaccine that he received causing false positive syphilis tests;  Relevant laboratory test results included: Treponema test - On 04-Jul-2022:  [false positive syphilis test]  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (false positive syphilis test).  At time of reporting, the outcome was Unknown for the event false positive syphilis test.
Patient had a terrible reaction, causing a lot of pain for him after receiving the shot. He was admitted to the hospital after getting the shot.
Red, swollen (Rt) arm 1 D after PNEUMOVAX shot given. Went to U.C. & they gave her a steroid shot & its better.
After vaccinated, symptoms were bruising easily, irritable, mood swings, crying, sleeplessness, change of personality from happy quiet child to irrational wild like behavior. Diagnosed 08/12/97 with ITP (idiopathic thrombocytopenic purpura) - low platelets at chronic low, bruising, petechia under 20,000. Treatments have ranged from prednisone multiple times, IVIG multiple (20) times, methylprednisolone (5x) no effect.
Left arm started hurting, very sore really bad around 2:00 pm the same day as injection. Around 10 pm got fever and had chills with uncontrollable shaking. Temperature was 102.2. Took 2 TYLENOL for fever. Would help fever then after about 5 or 6 hours would have fever again. Took 2 TYLENOL about every 6 hours to help fever. Next day still had fever, but the uncontrollable shaking stopped. The following next day April 27th the fever went away. Since then, I now have tremors and twitching about 10 times a day that last about a second. I have never had this problem before.
On 19Jan2012, mother called to report patient had developed Steven Johnson Syndrome in hospital. Developed blisters in mouth. Then started on antibiotics for finger wound.
malaise, nausea, fatigue, chills, body aches 2 hours following Phizer covid vax dose 1. Pt had lab-confirmed covid in June 2021.
Cellulitis, itchy, hot, red. Treating with KEFLEX, BENADRYL.
My father became weak and non-responsive in week following vaccine.  Could not communicate and passed 11 days after receiving vaccine.
pt recv vax; approx 4 hr later, devel T 104 & diarrhea; inject site reddened, size 5cmx2.5cm; acetaminophen given;
Seizure-like activity. Eyes rolled back, head shaking, lips blue, full body tense. Lasted about 1 minute. Post-ictal phase.  Second episode with similar symptoms took place in triage in the ED.
Fainted; Vomited; 102 degree Fever; Concussion resulting from fainting; head pounding; sensitivity to light and noise; sensitivity to light and noise; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 18:30 (Lot number: FJ1611) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfonamides" (unspecified if ongoing). Patient didn't have other medial history and didn't have covid prior vaccination. Concomitant medication(s) included: ACIDOPHILUS; MAGNESIUM GLYCINATE; MONOLAURIN [GLYCERINE MONOLAURATE]. Patient received other vaccine in four weeks. Past drug history included: Azithromycin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 2, lot number: EW0170, administration time: 03:30, location: Left arm), administration date: 24Apr2021, when the patient was 26 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, lot number: EW0150, administration time: 02:00, location: Left arm), administration date: 03Apr2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 23Dec2021 18:30, outcome "unknown", described as "Booster"; SYNCOPE (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "Fainted"; VOMITING (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "Vomited"; PYREXIA (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "102 degree Fever"; CONCUSSION (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "Concussion resulting from fainting"; HEADACHE (hospitalization) with onset 25Dec2021 04:00, outcome "recovering", described as "head pounding"; PHOTOPHOBIA (hospitalization), HYPERACUSIS (hospitalization) all with onset 25Dec2021 04:00, outcome "recovering" and all described as "sensitivity to light and noise". The patient was hospitalized for immunisation, syncope, vomiting, pyrexia, concussion, headache, photophobia, hyperacusis (hospitalization duration: 1 day(s)). The events "fainted", "vomited", "102 degree fever", "concussion resulting from fainting", "head pounding", "sensitivity to light and noise" and "sensitivity to light and noise" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of syncope, vomiting, pyrexia, concussion, headache, photophobia, hyperacusis, which included Physical Therapy, Magnesium recommended (400mg). Vomiting and fever recurred one week after vaccine. The patient underwent the following laboratory tests and procedures: body temperature: (25Dec2021) 102 degree fever; sars-cov-2 test: (06Jan2022) negative, notes: Nasal Swab.
Initial report received on 04 February 2013 from a consumer who is also the patient. A 61-year-old female patient with no concurrent illnesses or reported medical history, had received an intramuscular left deltoid injection of FLUZONE (lot number UT440AA) on 12 October 2011. The evening of vaccination the patient experienced a bad headache, loud noises in her head like frying sounds and echos; she could not hear from her left ear; and she had trouble with finding words when she spoke. The patient required medical evaluation. At the time of this report, the symptoms were still ongoing and the patient was continuing with follow-up visits to her physician. Outcome is not recovered. Documents held by sender: None.
Information has been received form a nurse on 11-FEB-2015 referring to a patient of unknown age. On 30-JAN-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection, 0.5 ml subcutaneously (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever; Injection site pain/ pain at the injection site; overall muscle pain/ generalized muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Enquired, the consumer called requesting information about the symptoms experienced after the administration of the first dose of the Pfizer COVID-19 vaccine. It was reported that, the patient was administered with the first dose of the Pfizer COVID-19 vaccine on Saturday and on Sunday, 24 hours later, he started with fever, injection site pain/ pain at the injection site and overall muscle pain/ generalized muscle pain. Stated that, the pain has gradually diminishing. Stated that, he was suggested to take Tylenol for symptom management. Enquired, the consumer called requesting information as to whether he could be administered with the second dose of the vaccine considering that he has experienced symptoms after the administration of the first dose of Pfizer's COVID-19 vaccine. The patient was advised to refer to his physician for further information and management. Treatment was received for the events. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
FEEL SLUGGISH; BREATHING KIND OF HEAVY, OUT OF BREATH A LITTLE BIT; DEHYDRATED; TEMPERATURE 98.8; ARM SORENESS; LIGHTHEADED, DIZZINESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate asthma, penicillin allergy, and egg and chicken allergy, and other pre-existing medical conditions included that patient got flu shot in 2011 and had fever afterwards, but usually never gets fevers. patient had allergies (took shots as kid) and stated some complaints "could be pollen". The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 at10:15  in right arm for prophylactic vaccination. Concomitant medications included loratadine. On 29-MAR-2021, the subject experienced lightheaded, dizziness. On 29-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F, 97.1 F. Treatment medications included: paracetamol. On 30-MAR-2021 20:00, the subject experienced temperature 98.8. On an unspecified date, the subject felt sluggish and experienced breathing kind of heavy, out of breath a little bit, and dehydrated. The action taken with covid-19 vaccine was not applicable. The patient recovered from temperature 98.8 on 31-MAR-2021, had not recovered from arm soreness, and the outcome of feel sluggish, lightheaded, dizziness, breathing kind of heavy, out of breath a little bit and dehydrated was not reported. This report was non-serious.
Patient with history of ischemic left MCA stroke, chronic respiratory failure and tracheostomy dependence, G-tube dependence.   Patient was brought to the ED via EMS on 11/9 for evaluation of difficulty breathing. Patient was noted by nursing facility staff to be hypotensive in the 80/40s, hypoxic in the 80s, and hot to touch with a temperature of 101.2F. There were concerns for sepsis, prompting staff to call 911. In the ED, patient was tested for COVID by PCR and was positive; he was placed on 6L FiO2. At baseline, patient chronically on 0-2L via trach. Ultimately patient was admitted 11/9 - 11/18 for sepsis, suspect secondary to COVID-19 and acute hypoxic respiratory failure. Patient has received COVID primary vaccine series.
I had a slight headcold after the 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset May2021, outcome "recovered" (May2021), described as "I had a slight headcold after the 1st dose". Therapeutic measures were taken as a result of nasopharyngitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms: Full body muscle aches/joint pain, weakness in arms and legs, fatigue, headache, occasional balance issues/dizziness, daily shooting pain (arms,  knees, groin and hip)
Red rash area the size of quarter on right cheek on face. Had a steady tingle. This quarter sized area is now the size of a soft ball and is now spread across entire right cheek, half way over my right eye and spreads into my hairline and back of ear.
Complained of pain on injection site side at neck up into back of her head. B/P 124/80, P 93 O2 sat 98%. Instructed to see her MD. No difficulty breathing.
Patient received booster dose 6 days early.  Patient reported injection site soreness not outside expected reaction.  No treatment required.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Nausea-Mild
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot # were unknown). On an unknown date the patient experienced itchiness and redness at the unspecified injection site. The outcome of event was reported as recovered/resolved. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a nurse concerning an 18 month old patient who on 22-JUN-2010 was vaccinated with a first pediatric dose of VAQTA (Lot# 667261/0261Z). The nurse reported that the patient developed a severe rash the morning after administration of VAQTA. The patient was examined in the office on 23-JUN-2010 and 25-JUN-2010. The rash was located on the anterolateral thigh and across the trunk. At the time of this report, the patient's outcome was unspecified. Additional information has been requested.
BLEEDING NOSE; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the subject experienced bleeding nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding nose on JUL-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient received vaccinations of Fluzone QIV NP that expired, with no adverse event; Pregnant woman received vaccinations of Fluzone QIV NP that expired on 30-Jun-2021, with no AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Medical Information (Reference number- 00768512) and transmitted to Sanofi on 14-Sep-2021.  This case involves a 32-year-old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after she received expired dose at 32 weeks of pregnancy, during third pregnancy trimester (expired product administered and exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was reported as 06-Feb-2021.  The estimated due date is 18-Nov-2021.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  The patient had no previous pregnancy/ies.  On 14-Sep-2021, the patient received a 0.5 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ702AA and expiry date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination (expired product administered and exposure during pregnancy).  It was an actual medication error case due to expired vaccine used and vaccine exposure during pregnancy (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills, fever, extremely sore arm, aches, skin even hurt. Took some ibuprofen and Tylenol.
AFTER THE SECOND DOSE OF THE COVID-19 VACCINE (MODERNA) HAD BEEN ADMINISTERED, THE PATIENT FAINTED WITHIN 15 MINUTES OF OBSERVATION OF THE VACCINE. PATIENT IS APPROXIMATELY 6 MONTHS PREGNANT
patient described nausea, fever, chills, and general unwell feeling that took 5 days to resolve.
This spontaneous report as received from a physician assistant via the company representative refers to a 61 year old male patient. On 01- APR-2014 the patient was vaccinated with one dose of ZOSTAVAX (Lot # reported as J010447, Exp date unspecified) shot in the arm for the prevention of shingles (dose, frequency and route unspecified). Concomitant therapies included amoxicillin (manufacturer, dose and frequency unspecified), MOTRIN, 800 mg, atorvastatin (manufacturer, dose and frequency unspecified), and NORVASC dose and frequency unspecified). On 15-APR-2014, after receiving ZOSTAVAX, the patient broke out with shingles. Patient visited to office for medical attention. The event was treated with acyclovir (manufacturer, dose and frequency unspecified). No lab diagnostics studies performed. Seven days after the outbreak of shingles, "the spots were drying up" and that the patient had begun recovering. Additional information has been requested.
Six weeks after second injection developed central serous retinopathy. Obtained COVID-19 test ~48 hours after diagnosis, results negative. Unsure if its related to the vaccine.
Pt called stated site of injection of ZOSTAVAX - Red - Swollen and warm to touch.
Woke up ~14 hours post injection to moderate fever (101 F) ,  severe chills,  and very severe aches and pains in joints and muscles.   Struggled to get up and down a set of stairs and had to go one at a time including holding the handrail (~43 year old male in very good shape, lifts heavy weights and runs 2-3 miles 3-4 times per week)  .  Managed to fall back asleep and woke up ~2.5 hours later with the same symptoms ,  plus higher fever (102 F) and additionally mild nausea and a very bad headache.    Took Tylenol and upon another 2-3 hour sleep had the fever more managed but dealt with the nausea, headache and aches/pains for the next 24 hours after that.   Symptoms resolved after about 36-48 hours , although I did not feel 100% back to normal until about 72-96 hours after this 2nd dose.
Woke up on 3-30-04 with a rash all over body and lips swollen. Being treated with Benadryl. Few spots noted at bed time 3-29-04.
t103, pulse rates elevated, slept for approximately 22 hrs p/vax; MD was notified of sx; ordered Advil for fever; give DT only if further doses needed;
Vasovagal Episode with Nausea  Vitals:  1226: BP 91/54, HR 73, RR 14 1228: HR 82, O2 97 1230: Blood Glucose 115, Temp 98.3 1231: BP 81/43, HR 84, RR14, O2 99
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. On an unknown date the patient was administered an improperly stored dose of (Oka/Merck) VARIVAX (lot # K003405, expiry date: 06-MAR-2016) (vaccination date, strength, dosing details were unknown). No adverse events were reported. The outcome was unknown. No product quality complaint was involved. Additional information is not expected as the reporter did not wish further contact.