chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; the patient was inadvertently administered a  dose of MMR II (Lot#R031636/Exp:11/1/2020)  by the intramuscular route, instead of the subcutaneous route; Information has been received from a medical assistant, referring to a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.     On 15-JUL-2019, the patient inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (recombinant Human albumin (rHA)) (strength unknown; lot# R031636 and expiration date 11-JAN-2020) by the intramuscular route, instead of the subcutaneous route for prophylaxis (incorrect route of product administration). No adverse effect reported.
On 12/27 woke up with 104 fever and couldn't keep anything down.  Had telehealth visit and they asked me to come in for testing and I tested positive fo Covid
NONE - The expiration for HIB on the box and vials was written as 18OCT17 and it was thought that the vaccine expired October 17, 2018 when it actually expired October 18, 2017. This was not found until the end of January 2018 when all of our vaccines were brought back to office after the 2 1/2 months of the vaccines being at the main hospital due to the vaccine refrigerator being broken.
States did have a rash after first dose on 12/28/20 on right arm for 10 days.  Did not and chose not to report.  Several days post 2nd injection, patient received full body/trunk rash on 2/11/21 and it remains ongoing.  Pt. states she is currently taking benadryl for rash
Red rash  on right arm the day after the vaccine.  Due to reaction to the first dose of the vaccine.  I spoke with the Covid line at my employer and was advised to seek treatment. I was instructed to use Benadryl and Ibuprofen.
always had the flu soon after the shot administered; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case involves an unknown demographic patient who had flu (influenza) soon after receiving INFLUENZA VACCINE.  The patient had received influenza vaccines in the past for prophylactic vaccination and always had flu soon post vaccination. The patient's past medical treatment(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza), soon (unknown exact latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient not had a flu shot in over a decade and not had the flu.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
4" x 4" swelling in right deltoid, very painful no redness, full range of motion.
This spontaneous report has been received from a female patient of unknown age with diabetes mellitus and sulfa drugs hypersensitivity as current conditions. On an unspecified date in April 2012, the patient was vaccinated with PNEUMOVAX 23, intramuscularly (strength, dose, frequency, lot# and expiration date were provided) "as a precaution". It was reported that on an unknown date, the patient overnight developed a violent reaction causing her arm to swell and became hot, and the reaction also affected her shoulder. The outcome of peripheral swelling, musculoskeletal discomfort, vaccination complication and feeling hot was reported as recovered. At the time of this report the causality between the aforementioned events and PNEUMOVAX 23 was not reported.
hospitalized transferred from an outside facility with fluid overload and worsening hypoxic respiratory failure.
Night sweat; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EH9899, Expiry Date 31Mar2021), via an unspecified route of administration on 31Dec2020 at 0.3 mL, single dose for COVID-19 immunisation. Patient age at vaccination was 35 years. Medical history included ongoing Factor V Leiden (it's a blood clotting supporter) and asthma. The patient's concomitant medications were not reported. The patient reported since she got her first vaccine on 31Dec2020 she had had night sweat every single night to the point she had to get her clothes off and change. The event had not resolved.
9:05 am no adverse reaction 15 minutes later. No treatment needed. Mother voiced understanding and will continue to monitor patient and follow up with TYLENOL every 4 to 6 hours for fever.
Vaccination given at 3:28pm,  at 3:40 patient reported sensation of itch in her arm and left hand. Also reported sensation of swelling in left hand. Visual comparison of left vs right hands did not reveal any obvious differences, however I proceeded to treatment at 3:42 with oral diphenhydramine liquid at 25mg dose. At 3:55, patient reports symptoms improving (i.e. no sensation of swelling or any visual disparity left vs right hand).  At 4:22 no symptoms present and parent of patient and patient left treatment area.  Telephone contact with parent at 5:20pm, patient has no itching or swelling sensation at all.
Felt really tired. When I woke up, had rapid heart rate. Couldn't catch breath walking to kitchen. Difficult to talk. Rested and felt better.
Sore throat; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 32-year-old female patient received BNT162B2 (lot EK5730) via an unspecified route of administration on 22Dec2020 10:30 AM at a single dose as COVID-19 vaccine. Medical history was not reported. Concomitant medications included lysine supplement and loratadine (other medications in two weeks). The patient had known allergies to amoxicillin. It was reported that the patient had an adverse event of sore throat, 4 days after vaccine on 26Dec2020 14:30 (02:30 PM) assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She had no other vaccine within four weeks prior to the COVID vaccine and had no Covid prior to vaccination. She had the Covid tested (other) post vaccination on 23Dec2020 with a negative result. The patient was not pregnant at the time of vaccination. The outcome of the event was unknown.
No additional AEs were reported.; Medical assistant reported that a patient received an expired PNEUMOVAX 23.     .; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 26-MAY-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter (ml), for prophylaxis (lot number t028093 has been determined to be valid for pneumococcal vaccine, polyvalent (23-valent), expiration date reported and established as 24-APR-2022) (strength, route of administration and anatomical location were not provided).  No adverse event reported.
It's the evening of 1/13/22 and my left arm is still swollen, sore, and now itchy. The redness has also begun spreading around my arm and my armpit is also swollen. The morning after the vaccine (1/11), I woke up incredibly ill: fever of 101.7, sharp pain type headache, weak, joint aches and pains, whole body aches, fatigue (not able to get out of bed or stand for more than a few short minutes), neck was a bit stiff/sore, had no interest in food or tea (my usual favorite daily drink), runny/stuffy nose. On 1/12, felt mostly the same except 2 hours after taking 2 ibuprofen (at 1:30pm) in the afternoon, my head felt better and I was able to stand for more than 5 minutes and eat a small dinner. 1/13 I woke up with more energy, less of a headache, less body and joint aches, and was actually hungry. As mentioned, vaccination site is the main issue now, though nose is still a bit runny (at 8pm) and still not able to eat a sizeable meal. Tonight I'm not in pain, no headache either.
expired vaccine was administered to a patient; This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 27-AUG-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # s021092, for prophylaxis, which had expired on 18-MAY-2020 (expired product administered) (dose, route and site of administration were not reported).  The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: s021092; expirationdate: 18-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
SWEATS; SORE ARM; FATIGUE; MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sweats, sore arm, fatigue, and muscle aches. The action taken with covid-19 vaccine  was not applicable. The outcome of the fatigue, sweats, muscle aches and sore arm was not reported. This report was non-serious.
I noticed one of the veins in my underarm was swollen in th same arm/ I have a blood clot i my upper right arm/ have to be evaluated for DVT; I noticed one of the veins in my underarm was swollen in th same arm/ I have a blood clot in my upper right arm/ have to be evaluated for DVT; This spontaneous report was received from a female patient of unknown age reporting on herself, via a company representative. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.    On 23-FEB-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml syringe, lot number U010534 with expiration date 31-OCT-2022, in the right arm for prophylaxis (route of administration was not reported).     The patient reported that on 04-MAR-2022 she noticed one of the veins in her underarm was swollen in the same arm of the vaccine. On 09-MAR-2022, she went to see the primary-care physician (PCP), who told her that she had a blood clot (Thrombosis) in her upper right arm and that this should be evaluated for deep vein thrombosis (DVT). The outcome of thrombosis and deep vein thrombosis was not reported.  The causal assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. The PCP believed that it should be reported as an adverse reaction to the pneumococcal vaccine.  Upon internal review, the events of thrombosis and deep vein thrombosis were determined to be medically significant.
Pain in site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2021) for prophylaxis.   On 20th August 2020, the patient received the 2nd dose of Shingrix. In September 2020, 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported pain in site of injection after administration of Shingrix, 2nd dose. The reporter did not consent to follow up. The batch number was changed from X652X to XG52X.
Per the patient: A few hours after I received the flu vaccination, I noticed I had a few itchy spots on my legs. I did not think anything of it, and I left work around 3:30 p.m. I was getting ready to go to the movies and I had become extremely itchy. I noticed my face started to feel warm and I just kept an eye on it. The movie I saw started at 7:30 and while I was in there, my entire body started itching and my lips became very tender to touch and swollen. I took 3 Benadryl and went to sleep. The next morning, I was covered in a rash, and I was still itching. I was seen by Urgent Care, and they gave me a shot of steroids. The physician also sent in a prescription for Prednisone to take for the next week.
Patient received ZOSTAVAX shot 12/3/13 and developed pain in his elbow in the morning of 12/4/13. By 12/5/13 he developed a 4x6 circular red patch on elbow. He went to his primary doctor and was prescribed Cephalexin for a skin/tissue infection.
c/o onset of SOB, generalized body aches, fever lt arm swollen, tender 1 day p/1st vax went to pvt MD 3SEP92 no treatment just eval; told to rest;
Patient admitted to hospital on 8/26/21 for shortness of breath, mild cough, body aches, nausea, vomiting, and diarrhea. Also with left sided abdominal pain. Tested positive for COVID-19 on 8/26/21. Patient is fully vaccinated with Pfizer. Dose #1 4/13/21; Dose #2 5/4/21 (lot numbers unknown). Also reports that he was previously infected with COVID in 2020. Started dexamethasone 6 mg daily x 10 days. COVID did not progress to lower respiratory tract infection.  Patient discharged 8/27/2021.
Information has been received from a doctor of pharmacy concerning a 49 year old female hospitalized with pneumonia who on 1/14/05 was given a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported) via a central line (the physician orders were to give it IM). Subsequently, the patient coded but did not die. The patient required intervention of the crash cart (therapies not specified). It was noted that the patient was to be discharged from the hospital that day, but her hospital stay would now be extended. There was no product quality complaint involved. The patient's outcome was unknown. Patient coded but did not die was considered to be immediately life threatening. Additional information has been requested.
pt dizziness/ sweating BP: 78/46 Pulse 78 o2SAT 99%  Advised patient to drink water and lay down. Patient stated her baseline BP is 100/58 or 110/60 BP: checked after 15 minutes 104/64 pulse 80  Patient recovered from adverse effects.  Advised oatient to consult with her gynecologist before second shot regarding symptoms.  Est, Expected date of delivery  is 6/15/2021.  #21 left for home
Mom reported child got puffy around eyes the day after vaccination 2/19/09. It resolved 2/24/09. The evening of 2/23/09 child presented with patch, red hives to cheeks 12 hrs. Then they dimmed and hives presented chest, belly & bottom on 2/24/09. On evening of 2/24/09 hives dimmed and moved to face and sparsley on legs to date. T 101.5 highest2/24/09, 100.0 this am. Emergency room phone call by parents. Was told to give child tylenol and benadryl. They did and symptoms improved.
my Lungs lite up like a Tree from the Contrast and showed that I had a had a population of 5mm nodules occupying my lungs bilaterally in the lower bases.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: PULMONARY MASS (non-serious), outcome "not recovered", described as "my Lungs lite up like a  Tree from the Contrast and showed that I had a had a population of 5mm nodules occupying my lungs bilaterally in the lower bases.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was stated by the patient that "Right after I had my first COVID-19 Vaccination I was scheduled for a Heart Calcium Scan. I went to have the Heart Scan done and very fortunately my Score was only 22. But, my Lungs lite up like a  Tree from the Contrast and showed that I had a had a population of 5mm nodules occupying my lungs bilaterally in the lower bases. I had a bad reaction to the Pfizer COVID-19 Vaccination and Booster. My Lungs are now covered with 5mm and 6 mm nodules that no one will touch. I got C-T Scans of my Chest every 3 months for 2 years and now q 6 months."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Anaphylactic episodes starting the next day after the vaccination. This went on  intermediate, for four days, the fourth day  by far was the worst. Closing of throat, labored breathing, lightheaded, mental fog, somewhat disoriented, slight headache, and fatigue. Use of oxygen 3.0, Ativan and Benadryl rotated 3 of 4 days.
Pneumovax within 3 hrs of dose pt arm began to swell by 12AM swelling ranged from elbow to shoulder with pain radiating down to waist. Went to ER had prednisone observed 1H swelling reduced then sent home with antibiotic steroid and prednisone.
This spontaneous report as received from a healthcare worker, referring to patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose VARIVAX which had Lot number M033905 with expiry date on 20-JUL-2018 (strength and route were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature as follows: >14 farenheit grade but < 46 farenheit grade for 40 minutes; >14 farenheit grade but < 46 farenheit grade for 40 minutes; >14 farenheit grade but < 46 farenheit grade for 50 minutes and had a previous excursion recorded by a data logger of >14farenheit grade  but < 46 farenheit grade  for "5.3 hours" and >14 farenheit grade but < 46 farenheit grade for 50 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008241: US-009507513-1703USA008236: US-009507513-1703USA008242:
Information was received on 14-OCT-2016 from a field employee. He reported that per the physician, a patient (age and gender not reported) who was administered the ZOSTAVAX vaccine developed shingles. The patient's medical history, concurrent conditions and concomitant medications were not reported. The outcome of shingles was not reported. The physician did not rate the causal relationship between ZOSTAVAX and the shingles. No further information is expected as no contact information was provided.
experienced more pain compared with other vaccines; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "experienced more pain compared with other vaccines".  Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 3rd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were unknown. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient experienced feeling the medicine going into his tissue during the injection, soreness at the injection site and feeling tired. The patient had taken ibuprofen for the soreness. The patient declined to provide full demographics details only gave phone and zip code. The patient received 1st dose of SHINGRIX on 4th January 2019 was erroneously mentioned. The reporter did not gave consent to follow up.
Patient developed symptoms on 1/13/22 and tested positive for Covid-19 on 1/14/22. Patient had symptoms of, cough, SOB and Abdominal pain and was hospitalized for 3 days, from 1/13/22-1/16/22.
Dizziness hearing loss, fatigue, injection site pain Narrative:  Initially experienced fatigue and injection site pain. On 1/11/21 developed hearing loss in the right ear. ENT has diagnosed acute sensoroneurologic hearing loss.
None Diagnosed with COVID, 9 months after administration of vaccine #3. Diagnosed with COVID, 5 months after administration of vaccine #4.
Headache and general pain across skin and throughout muscles, as well as nausea on the first day after injection. Elevated body temperature. Beginning on the 13th, 4 days after injection, there was slight swelling on the right side of the lower back, with redness surrounding the area by about 2 inches. On the morning of the following day, hives covered the entire body, primarily on the upper torso and arms. Treatment began in the afternoon on the 14th with diphenhydramine hydrochloride, 25mg. Hives persist.
This spontaneous report as received from a nurse refers to a 16 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 26-MAY-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient experienced a sore throat the morning after the vaccine administration then progressed to facial swelling  and hives. Patient sought medical treatment at the hospital twice and was prescribed magic mouthwash and an Epi-pen on 9-20-23 then was prescribed prednisone on 9-23-23
Leaky syringe. More than 1/2 dose administered. Dose not repeated.
Pt taken to ER 2 days post given Prevnar in error-should have rec'd DTaP #5. L ant. thigh reddened, warm, swelling. Dx'd with cellulitis L thigh. Tx'd with Keflex.
listlessness, irritability, eyes rolling back 5PM-10PM day of vax;well & nl activity next day;repeat office exam 7PM umremarkable;
Fast heart beat, jittery, fidgety "too much caffeine" feeling. Slight dizziness.