chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received stated vaccines AM 7/24/12 - 7/25/12 AM developed fever, soreness & warmth to (R) deltoid, nausea. (R) arm tingling, (R) leg feeling tingling. 7.5 cm induration (R) deltoid, warmth to area, tender x 5 cm & edema.
After 6 days, my injection site. Hot, itchy, swollen to the size of of a softball. Went to the urgent care and they gave me antibiotics.
Sore arm (site of injection); sore arm (site of injection) across the chest (towards the left arm); has prominent lymph nodes at the armpit; This is a spontaneous report from a contactable consumer or other non healthcare professional (Patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route, administered in Arm Left on 15Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced sore arm (site of injection), across the chest (towards the left arm) and has prominent lymph nodes at the armpit. The patient was asking if you did not take a 2nd dose of Covid-19 vaccine, can she take it more than 3 weeks and would it still be effective. Then, she also wanted to know if the 1st dose of the Covid-19 vaccine was enough and can protect her to Covid-19. Moreover, the 1st dose was taken last 15Apr2021 and her 2nd dose was originally scheduled today (06May2021) but due to the symptoms that she was experiencing, the 2nd dose was moved on 19May2021. The medical questions were addressed by this program forwarded/referred to Medical Information. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache and fever day 2. Day 4 post injection developed cellulitis. Required antibiotics and steroid course. NSAIDs and ice packs.
Shingles; This is a spontaneous report from a non-contactable non-healthcare professional reporting for a patient. A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 post vaccination by nasal swab on 09Feb2021 which had negative results. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 10Feb2021, the patient experienced shingles. The patient was hospitalized for the event on an unknown date for 2 days. It was unknown if the patient received treatment.  The clinical outcome of the event shingles was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
myocardial infarction and coronary artery disease; myocardial infarction and coronary artery disease; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.   In on around 13-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prevention of shingles (herpes zoster). On an unspecified date, shortly after vaccination, the patient suffered severe chest pain and pressure. The patient was hospitalized and diagnosed with myocardial infarction and coronary artery disease.  As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to vaccination; the patient had also experienced mental and emotional distress due to resulting physical limitation and seriousness of his condition. Consequently, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment life, physical impairment and injury.  At the time of the report, the outcome of myocardial infarction and coronary artery disease were not recovered. The reporter considered the events previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the event of myocardial infarction was considered as medically significant.The reporters considered the events to be disabling.
Pt was home 1 1/2 hrs post vaccine & started to faint (Dad is a Dr. (cardiologist) and called it a "near syncopal episode" she also felt nauseous & tired.  When she fell she fractured her rt pinky & bruised her right knee (taped up by orthopedist).  Felt sluggish this am but went to school.  * Also has menstrual period.
The day after getting the vaccine he was at school.  He sprinted for about 50 meters from outside to the classroom.  Teacher noted his lips looked blue.  She laid him on the ground and he passed out.  He said he could hear people.  They called the ambulance.  Drove him to the ER and they ran more test.
This spontaneous case, received initially on 19-Mar-2018 was reported by other health professional and concerns a female pregnant patient of unspecified age. The patient's medical history was not reported. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, batch number: 195232, expiry date: 31-May-2018, route of administration, anatomical location not reported). It was reported that, the vaccine underwent two temperature excursions, one was at 48F for 15 hours maximum and minimum temperature reached was 35F for 30hours. Possible vaccines were administered. Follow up report received on 09-Apr-2018: Follow-up for this case is not being sought as information is not available". Hence this case is considered as lost to follow up.
Pt vaccinated with TD developed fever, pain in area, swelling in area, increase warmth, local adenopathy given Dicloxacillin 250mg QID x7.
Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-Feb-2023. Reporter's Comment: The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up. Additional Supportive Information: Patient received an expired Twinrix vaccine, which led to expired vaccine used.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with 6 doses of PNEUMOVAX23 (lot #, dose and route not reported) with in a year. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient was fine. The physician heard this story at a conference and stated that this occurred due to poor hospital department communication. Additional information is not expected.
Patient expressed she was dizzy at 12:42, 10 mins after receiving the vaccine. Temp: 96.9, O2: 99, P: 70, BP (1): 159/101. BP after 10 mins at 12:52 was 168/103.  Patient was given juice. Patient stated that she only had coffee and toast, and has not taken her BP medication. Patient stated her normal BP ranges from mid 130s-150s.
Client received covid19 vaccine and within a couple of minutes stood up and appeared "disoriented"  He did not follow commands initially to sit down.  He kept saying he was "dizzy"  He was encouraged to sit and put his head down.  He did attempt to get up again and became clammy to touch.  Breathing not labored.
Developing hives 5/20/2010 around 3 pm. BENADRYL prescribed no resp. distress.
c/o lt eye closing; took DPh & eye opened a little; skin rough under lt eye went to MD given PRed & cream; had flu shot about 2 1/2 wks a/this occurence;
At about 8:30am the day after vaccination, I started coughing heavily and chills ensued shortly thereafter, along with a headache and what felt like a fever. I did not diagnose the exact body temperature until about 12:30pm, where it was 104.2 degrees Fahrenheit. Under the supervision of my brother and his wife, both of whom are nurses, I was prescribed drinking fluids (water) and cooling off under a fan along with rest. By the next morning, I felt recovered, minus a minor headache and some minor coughing sporadically, but not in the intensity that I faced earlier.
28MAY96 high fever 104 & rash on face, neck, shoulders, raised, red;seen @ MD office 29MAY96 @ 930AM;CBC + diff drawn w/hosp lab;330PM 29MAY96 t106-staring glazed look;mom gave Motrin;t101.4 @ ER;
Developed tongue swelling, shortness of breath and dizziness within 1 hour of receiving flu vaccine. Used EPIPEN and proceeded to ER. Given IV steroids in ER.
This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was inadvertently vaccinated with two doses of PNEUMOVAX 23 (dose, route, lot# were not reported) within a 5 year time frame. Concomitant therapy was not reported. Also reported that on an unknown date, after the second administration of the PNEUMOVAX 23 the patient experienced itchiness and swelling at the injection site. No Product Quality Complaint (PQC) was involved. Action taken with PNEUMOVAX 23 was not applicable (also reported as therapy continued). The outcome of inadvertently administered two doses of PNEUMOVAX 23 within a 5 year time frame and itchiness and swelling at the injection site was unknown. Causality assessment of events itchiness and swelling at the injection site was not provided by the reporter. Additional information has been requested.
Pain in their hand after second dose; Fever after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in their hand after second dose) and PYREXIA (Fever after second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medication history was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in their hand after second dose) and PYREXIA (Fever after second dose). At the time of the report, PAIN IN EXTREMITY (Pain in their hand after second dose) and PYREXIA (Fever after second dose) outcome was unknown.            Concomitant medication were not reported  Treatment information were not reported
Patient developed increasing fatigue, unable to ambulate without falling, increased weakness, lost of taste , nausea, vomiting.  Patient admitted to hospital for adverse reaction.
At 1238 after vaccinating patient (14 y.o. female) with patient sat down in chair and reported feeling "dizzy". LVN gave water to patient and patient was able to drink water. PHN noted diaphoresis and pale skin. Patient reported she ate strawberries for breakfast. PHN took vital signs at 1240 and were BP 70/50, HR 76 and O2 98%. Patient vomited and reported she felt "better". Patient was assisted to sit in anti-gravity chair. PHN took vital signs at 1245 and were BP 91/69, HR 76, and O2 99%. Patient reported she feels "good". PHN Supervisor entered room and was notified of the situation. Patient's mother offered emergency medical services. Patient's mother agreed. PHN contacted emergency medical services at 1248. PHN took vital signs at 1250 and were BP 92/67, HR 73, and O2 100%. At 1302 emergency medical services arrived on scene and assumed care. At 1314, patient's mother declined hospital transportation and reported they will go to primary care doctor for follow up. At 1323, patient's mother signed and emergency medical services left the scene. Patient denied symptoms and was alert and oriented to person, place, time and situation. PHN educated patient to let her mother know if she doesn't feel well again. At 1326, patient left facility with mother and family.
I had two days of side effects like arm pain, fever, chills after my vaccination on 10/21/2021 around 5 pm ET. However on 10/24/2021, I woke up with vertigo. This lasted all of 6 weeks (just recovered). My PCP felt it might be vestibular neuritis, which is inflammation of the vestibular nerve. I am NOT SURE this is related to the Moderna Covid19 vaccine however wanted to report this happening on day 3 after vaccination. I am reporting it as a patient only, my Dr did not indicate any correlation to vaccine. If it is a rare side effect (based on other such reports), may help to inform to users of a small likelihood in labeling, may be especially important for others that might work on site and with machinery.
This case was reported by a pharmacist via call center representative and described the occurrence of throat swelling in a 65-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Concurrent medical conditions included egg allergy, fish allergy and shellfish allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced throat swelling and documented allergy to administered drug. On an unknown date, the outcome of the throat swelling and documented allergy to administered drug were unknown. The reporter considered the throat swelling and documented allergy to administered drug to be possibly related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: Age at vaccination was not reported. The patient had a reaction to the flu vaccine once where her throat swelled up, and she thought it was related to the egg content. The patient has an egg allergy and her throat swells up if she eats eggs. It was unknown whether the flu vaccine was a GSK product.
Vaccine was stored in refrigerator and administered to the patient past expiration date 22-Dec-2021; Patient administered dose past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator and administered to the patient past expiration date 22-Dec-2021) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator and administered to the patient past expiration date 22-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered dose past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator and administered to the patient past expiration date 22-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 28-Jul-2021, the beyond the use date was started.   It was reported that, the vaccines were stored in refrigerator and temperature ranges were between 2 to 5 Celsius. On 22-Dec-2021, the vaccine was expired and on 04-Feb-2022 administered to the patient past the expiration date.   No treatment medications were reported.
This spontaneous report was received from a 72 years old female consumer without any drug allergy or pertinent medical history regarding herself. On 21-NOV-2011, the patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot# and expiry not reported). Concomitant medications included unspecified thyroid medication. A week after receiving the ZOSTAVAX approximately on 28-NOV-2011, the patient experienced a sinus infection that took 2 months to go away(recovered in January 2012). Antibiotics were given as treatment. In September 2012 ("Two months ago"), the patient experienced a burning pain, including electric shock sensations at the bottom of her feet. She was told by an healthcare professional (HCP) that she has small fiber neuropathy. A computerized axial tomography(CAT) scan was performed(results not reported). Patient sought medical attention(unspecified). The outcome of small fiber neuropathy was reported as not recovered. Additional information has been requested.
Moderna covid vaccine First dose given in Feb.; developed "COVID-19 arm" one week later that lasted about 5 days. Swelling, rash, hot to touch, and extremely itchy.  Applied cold compresses and symptoms eased day by day  second dose no reaction as of now except for low fever for first 36 hours
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored an unspecified number patients received improperly stored GARDASIL (strength, lot#, dosage, route and frequency). This is one of several reports received from the same reporter. Additional information has been requested.
Patient complains of chills and aches throughout her body, she self reported a fever, location of injection site is warm to the touch.  She said she felt dizzy.
High fever 104 degrees and prolonged crying X 2 days after immunization at 2 and 4 month most likely pertussis reaction.
Patient developed unknown type of dermatitis in foot 2 wks after vaccine. Pt also developed shingles 2 weeks after dose.
More pain than the first time which is not as much of a concern as the rash. She has noticed a red splotchy rash developing below the injection site and moving down.
Approximately 15-20 minutes after vaccination child became unresponsive, no respiratory distress. Mother emergently brought infant back to office. Infant was limp but with good vital signs. Quickly required consciousness in office. Monitored for 15 minutes. Released to home - EEG ordered.
patient was administered Menactra at age 11 years and then 10 months later; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA236741 and 2019SA240612 (same reporter).  This case involves an 11 years old patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that patient was administered Menactra at age 11 years and then 10 months later.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  In October 2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  It was unknown whether the patient had any adverse reactions.  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 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.  Information on the batch number was requested.  List of documents held by sender: none.
Blurry vision; double vision; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. A 9-decade-old (80+) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported her elderly uncle experienced blurry vision and double vision on an unspecified date with outcome of recovering. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015730 same reporter/drug/AE with different patient.
he stated he could " feel something go up my back" about 5 minutes after the vaccination.  About 15 minutes post vaccination he was standing next to the exam table and collapsed onto it, mom and I had to hold him upright, he was unconscious, he appeared to move his arms and neck in a jerking motion, color was pale to dusky, opened his airway, slapped his face. he appeared to revive. he had urinary incontinence.  rechecked vitals BP 100/60 pulse 80s. laid him on exam table. called 911. evaluated. oriented X3 by time of ambulance arrival was able to stand after sitting on side of exam table. he did not want to go to ER some mom took him home. he has fainted in the past but not the involuntary movement or incontinence. he complained of his hands going numb but the sensation returned.
devel pink macular rash on lt fore arm 18OCT95; achey generally-inj site no rxn @ all
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was inadvertently received an improperly stored dose of (Merck) VARIVAX (dose and route were not reported, lot# L038132 with expiration 01-OCT-2017) (incorrect product storage). The vaccines were exposed to excursion: -13.4 centigrade for 6 hours and 47 minutes. No adverse effect was reported. Additional information has been requested.
Redness, swelling, warmth, and itching at injection site. Symptoms developed 36 hours after injection and continued for over six days. Virtual physician visit advised localized allergic reaction Treated with Acetaminophen for pain, loratadine for histamine reaction (one every 24 hours) beginning on day two of symptoms; Triamcinolone Acetonide cream (.1%) beginning on day 3 or 4 of symptoms. After beginning treatment symptoms slowly subsided. Some residual redness and soreness remained one week after injection.
I have fever, throats scratch, cough, breath with dificulties, body pain, back pain, very very tire, thirsty, Head pain, congestion, dificulties to function
Presented with sob.  He was admitted for respiratory failure and covid pneumonia. Tx w/abx, steroids, zinc, O2; pt did not improve and family elected to withraw care.
I tested positive for COVID-19. I had a fever, aches, and chills. I had a video visit with my doctor, and they prescribed me Paxlovid. I started feeling better and tested negative for COVID-19. Two days later I started having sinus problems and I tested positive for COVID-19 again.
Pt recvd vax & 3-4 days p/inject exp erythema, swelling & rash (4th day) in arm/shoulder;