chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A pharmacist called and reported an AE. The HCP reported that a patient received their first and second doses of GARDASIL 9 when she 45 years old. The patient came into the pharmacy and is now 47 years old and was requesting her third dose of GARDASI; No additional AE reported; This spontaneous report has been received from a pharmacist, regarding an adult (by the tie of the report 47-years-old) female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On unspecified dates (reported as when she was 45 years old), the patient was vaccinated with the first and second of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (strength, dose, route an anatomical location of administration, lot number and expiration date were not reported)  The pharmacist reported that the patient, with 47-years-old, went into the pharmacy requesting her third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  The caller confirmed the patient had not received the third dose by the time of the call.  No additional information as provided to further clarify these details. No additional adverse event was reported.
pt recv vax 18SPR95 & 1-2wk p/vax exp a black dot on leg;pt was initially dx by a MD as a spider bite (spider presumed to be brown recluse) tx w/cortisone;rash became gen & was considered to be a rxn to vax;
Received vaccines 3/9, began feeling tired that evening, the developed headache, nausea, dizziness. Upon exam 3/11, facial puffiness, pale, otherwise WNL.
it is very tender; lump up to side of my neck; My collar bone on the side that I have gotten the shot at, my collar bone started to hurt; sore from that lump up to side of my neck; collar bone started to hurt; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EWO185), via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 60-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any prior vaccination. On an unknown date, the patient stated that last night she started to notice that her collar bone on the side that I have gotten the shot at, my collar bone started to hurt and there is small lump there and it is very tender and sore from that lump up to side of my neck. The patient received treatment but was just took some Tylenol. The outcome of the events was unknown.  Follow-up (18Aug2021): Follow-up attempts were completed. No further information was expected.
p/receiving 2nd dose of Engerix-B vax aches & pains in knees, legs & fingers; pt exp same sx w/1st dose but sx worsened p/2nd dose;
Patient experienced swelling and body aches. She took a ibuprofen and iced the area and felt better.
Tested positive for COVID19; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive for COVID19) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: BAMLANIVIMAB (Reporter stated patient recently received an antibody infusion called bamlanivimab).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID19). At the time of the report, COVID-19 (Tested positive for COVID19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, SARS-CoV-2 test: other (Positive) Tested positive for COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information was specified.
profuse bleeding at injection site; This is a spontaneous case received from a contactable consumer (patient) via Medical Information Team. An 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9262) via an unspecified route of administration in left arm on 06Feb2021, 12:00 (age at vaccination 87-year-old) as single dose for COVID-19 immunisation. Patient medical history includes ongoing blood pressure started on an unknown date, stents on an unspecified date in Sep2020. Concomitant medications include Clopidogrel for blood thinner, Carvedilol, Felodipine, and Olmesartan for blood pressure. Patient historical vaccine includes Flu vaccine on an unknown date for flu immunisation. On 06Feb2021 it was reported as patient received first dose and reports profuse bleeding at injection site for 8 hours. She takes blood thinner, Clopidogrel. The Pfizer COVID-19 Vaccine injection was just a little needle going in. The bleeding was from the injection site and she bled down through her sweater and had to give pressure but she could not get enough pressure on the site. she knew it started a little bit at that point when she got the injection initially; but she was not aware it was going on until a couple or few hours later. She just had a little band-aid that they put on the injection site because it was not a problem at the time they injected her to their or her awareness. Bleeding went on for about 8 hours; and she recovered completely that day as far as she is aware. She has taken the flu injection and something else for surgery, she has never had any kind of reaction like this profuse bleeding. She has been on blood thinner Clopidogrel and never had this profuse bleeding before. The outcome of the event was recovered on 06Feb2021.  No follow-up attempts are possible. No further information is expected.
I was having heart palpitations diagnosed as PAC. I have a decrease in palpitations but I am still experiencing some although less, I wore a heart monitor for a week, results not yet available.
12-9-08 Pa from pt father; c/o soreness of Rt arm since flu vaccine of 11-4-08; initially had some redness which resolved; pain began approx 7 wk later; pt c/o difficulty lifting arm due to pain.
Red, swollen, warm spot at area of injection. Nausea and vomiting. Went to ER and received Phenergan which relieved nausea and vomiting. Site on arm is "getting better".
Information has been received from a nurse practitioner who was working at that office as a nurse concerning a 12 month old patient who was vaccinated with the first dose of VARIVAX (Merck). The child developed a rash at the injection site within minutes of receiving the vaccine. Follow-up information was received from the nurse practitioner who reported that the patient's "3 bumps" resolved by the time the patient left the office after her vaccination. Then the patient's mom called on 06-JUL-2009 and said the patient's "3 bumps" returned over the weekend and were still present as of 06-JUL-2009. Additional information has been requested.
Pt presented to the hospital with palpitations and chest pressure.  EKG showed ischemic changes and pt was admitted, and was found to be COVID positive.
RASH ON LOWER LEG. A LITTLE DISCOMFORT.  RED/BLUE COLOR ABOUT 2& 1/2 IN IN DIAMETER.
COVID infection following COVID vaccine series 01/28, Pfizer, dose #1 02/19, Pfizer, dose #2 11/08 pt cc: fatigue, headache, loss of taste or smell, myalgias, rhinorrhea, dyspnea exposure: unknown 11/18 COVID swab, result: detected 11/23 SARS-COV-2 Variant Sequencing result: pending 11/29 CXR impression: 1. Lung hyperinflation likely secondary to air trapping again noted, otherwise, no radiographic evidence of acute cardiopulmonary disease. 2. Nonspecific bowl gas pattern.
Drug ineffective; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 07May2021 as dose 2, single (Lot number: EN6208), in right arm and on 14Oct2021 as dose 3 (booster), single (Lot number: EFE3590) at the age of 48 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CRESTOR, start date: 08Apr2022, stop date: 12Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (24Jul2022) Positive, notes: I used a Siemens's antigen test. It was positive on 24Jul (7 days after my last). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received other medications in two weeks of vaccination. Treatment started on 12Jul2022. Treatment stopped on 17Jul2022. Six days after of last dose of Paxlovid, patient started experiencing cold like symptoms: congestion, some sneezing, sinus pressure. Initially thinking it could be seasonal allergies or potential for sinus infection. After reading so many journals and articles on "rebound" with Paxlovid, patient used a Siemens's antigen test. It was positive on 24Jul (7 days after her last dose). Known allergies and other medical history were reported as No.
itchy red hives around arm from shoulder to elbow beginning approx. 6 days after injection. itching temporarily alleviated with hydrocortisone cream. hives persisting for 5th day at time of report
Vaccine administration error.  Moderna Lot# 048F21A  expired on 01/22/22.  Was administered to the patient as a booster dose on 01/24/22.
dizzy, nausea, vomiting passed out for 1-2 minutes,  said he could not sleep well the night he received the vaccine
Patient had local swelling and redness with induration on RUT and RLT at the sites of vaccinations.
One week after injection my right arm began itching and became red and warm to the touch. It felt like mosquito bites with a knot in the center. I took an over the counter antihistamine and Tylenol as recommended on the vaccine adverse reaction website.
Prior to vaccines baby was feeding well and gaining. Within 2D-3D of vaccines started with difficulty feeding with subsequent weight loss necessitating hospitalization. Extensive evaluation has not revealed any other cause and he continues to have problems. Had NG fdg, in hospital. Will not take bottle since 9am yesterday. Parents said he has been on nystatius for oral thrush x one week. Intake had been a little less than until he stopped yesterday. No fever, some cold symptoms previously, none now. Baby has not been fussy, just refuses to eat. Dad states "has not been same since 2 mo. shots 11/29. Seems to have gotten a little worse each day. Emesis yesterday after attempting feed. Small urine this am. Some red in diaper with urine per day. Pt alert calm, lungs clear abd. soft.
Had injection later afternoon and a few hours later bad chills and all muscles aching everywhere. Temperature of 99.8 . Normally I'm a night owl put myself to bed and literally stayed in bed the next day. No temperature next day but muscle aches all day. Next day felt better about 80% but by end of day 100%. Never had any reaction ever before.
About 22 hours after vaccine I started experiencing  dizziness, balance problems, fatigue, low fever (99.8f), headache, muscles pains in both shoulders, pain at sight, VERY urgent urination,
the patient was admitted with severe headache and backpain. over the course of 3-4 days, he developed progressive neurologic symptoms (bilateral facial nerve palsies, numbness and dysesthesia of the lower extremities, bilateral lower extremity weakness and loss of reflexes) consistent with acute inflammatory demyelinating polyneuropathy.
Patient received a pediatric dose instead of an adult dose. No adverse reactions to vaccination. Patient's mother was notified of the incorrect dose and was advised to get the adult Pfizer dose for his next dose.
sore arm; Was unable to remove cleo tubing from site and had to start a new one; temperature 100; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COMPLICATION OF DEVICE REMOVAL (Was unable to remove cleo tubing from site and had to start a new one), PYREXIA (temperature 100) and HEADACHE (headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM injection for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included AMBRISENTAN, RIOCIGUAT (ADEMPAS) and RIVAROXABAN (XARELTO) for an unknown indication.   On 10-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL SODIUM (Subcutaneous) .012 continously. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), COMPLICATION OF DEVICE REMOVAL (Was unable to remove cleo tubing from site and had to start a new one), PYREXIA (temperature 100) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (temperature 100) and HEADACHE (headache) was resolving and COMPLICATION OF DEVICE REMOVAL (Was unable to remove cleo tubing from site and had to start a new one) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Body temperature: 100 (High) Body temperature 100 F.         No treatment information was provided.   Reporter did not allow further contact
Vaccine Administration Error: Pharmacist administered Janssen vaccination after its BUD & Time of 5/11/21 and 6pm. Vaccine administration occurred on 5/11/21 @6:58 pm.  Outcome: contacted manufacturer on 5/12/21 around 8:30 a.m. and was informed by manufacturer that clinical or data studies are provided for Janssen use beyond expired BUD and Time. Pharmacist was informed by manufacturer to complete VAERS, contact  patient, and contact patient's primary care physician. No information was given whether or not patient needs to be revaccinated. Manufacturer said to check with patient's PCP. Patient was contacted on 5/12/21 to inform of the medication vaccination error and patient states that he is ok with the situation and does not have any concerns. Patient's PCP was also contacted on 5/12/21 and pharmacy was awaiting a call back from the patient's prescriber office  as they have not return the pharmacy call yet.
At 11:45 am client felt dizzy and nauseous. We walked her to a cot so she could lie down and got water for her. Blood pressure at 11:52 am was 138/96, which is higher than her normal blood pressure. At 11:55 am she reported a headache starting. Around 12:00 pm she reported that the dizziness was mostly gone, but the headache was worse. Around 12:05 pm she ate some goldfish and about 5 minutes later reported that the goldfish as well as the water both helped with the nausea. At 12:20, only the headache remained and she felt well enough to have her husband drive her home.
The day following the second injection the patient noticed loss of smell and taste.  No other symptoms of COVID.  No fevers, chills, cough or dyspnea
Moderna COVID-19 Vaccine EUA. Redness, itching, swelling, heat, headache, 7 days post vaccination
PFIZER COVID 19 VACCINE EUA: ADMINISTRATION ERROR. INDIVIDUAL RECEIVED VACCINE DOSE FROM VIAL STORED FOR MORE THAN 12 HOURS AFTER PUNCTURE BUT LESS THAN 24 HOURS OF PUNCTURE. PFIZER STATED THEY HAD ADDITIONAL STABILITY INFORMATION FOR UP TO 24 HOURS AFTER PUNCTURE OF VIAL BUT NO EFFICACY DATA FOR THIS OFF LABEL USE. RECOMMENDED MEDICAL DIRECTOR AND NURSING FACILITY DISCUSS WITH INDIVIDUAL THAT THEY MAY BE REVACCINATED IF THEY CHOOSE BASED ON LACK OF EFFICACY DATA.
autoimmune disorder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
VR  received first dose and was observed for 15 minutes and departed the vaccination site. Approx. 5 minutes after departing she returned saying she was having difficulty swallowing. No other symptoms reported but did indicate she had some anxiety.  EMS was called to the site and was transported to the nearest facility.
Rash started at my feet and moved up to my face. Itchy red raised dots all over body.
terrified; nervous wreck; sore arm after receiving the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: ER8737) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEAR (non-serious), outcome "unknown", described as "terrified"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous wreck"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after receiving the first dose".  Additional information: Patient had COVID and then she had the first shot. Patient is a nervous wreck over taking the shot because nobody knows what is going on.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable nurse. A 67-year-old male patient received on 16Sep2016 11:38 PREVNAR 13, (lot number M98915, expiration date 30Sep2017, NDC number 0005197101) at 0.5 ml single dose in the left arm as routine vaccination. Concomitant medication included ongoing losartan for blood pressure since an unknown date (it was reported that has been taking for at least 1 year). Medical history included elevated blood pressure and diabetes, both ongoing. On 16Sep2016 the patient had redness, injection site warmth, body aches, weakness, felt warm and painful arm. Course was as follows: the patient received vaccination on 16Sep2016.  He came back into the office on 19Sep2016 and reported that the evening that he received the pneumococcal 13-val conj vac (dipht crm197 protein), he experienced redness, warmth at the injection site, body aches, weakness and felt warm. His arm pain was initially a 7/10, then a 5/10 and when he came to the office on 19Sep2016 it was a 4/10.  He has noticed improvement in the redness and pain. He followed up again on 22Sep2016 and the redness and pain had improved further. He has not been in contact with the office since, so the caller does not know if the side effects have continued to improve or resolve. He was supposed to come into the office on 09Dec2016, but he canceled that appointment. The patient was advised to continue taking Ibuprofen, 400mg, for the pain and to contact the office if the side effects did not resolve. Outcome was unknown.
pt recv vax 23JUN97 & 3JUL97 pt devel chickenpox that consisted of 50-100 lesions larger around the vax site, dec appetite, fever of 104 which lasted 48hr & one episode each of diarrhea & emesis;
Cellulitis, painful to touch, afebrile since immunization x 2 days ago. Keflex 250mg po tid x 10 days. f/U PRN. R arm.
Patient experienced itchy sensation 15 minutes post vaccination. Did not notice erythema/swelling until 2 days later, but had been taking ZZZQUIL each night, which has the antihistamine Diphenhydramine in it's formula. The redness and swelling have diminished. The patient denies any respiratory symptoms.
Diffuse, red, itchy rash x  1 week, starting 1 week after vaccination
Sent to emergency  sweating couldn't breath chronic cough given steroids for week and breathing treatment.
Her arm started getting more and more swollen, hot, and very painfull. We put cold packs on it and gave her ibuprophin. It just kept getting worse and worse, she missed two days of school because of it, the school nurse sent her home and said to do what we were already doing and if not better Monday the 12th to take her to her doctor. However, we just moved here and she doesn't have insurance or a doctor yet, so we just kept using the cold packs and ibuprofen for the pain and inflammation. Finally by the 16th it started to go down and started itching, but it is now the 19th and her arm is still a little swollen, slightly painful and discolored. Not sure what to do.
Pt received Prevnar and moved out of the area the next day. The doctor didn't believe that the hives that developed the evening Prevnar was given, were not related to the vaccine because the children had received it 2 X previously. Benadryl relieve the hives but as of 2/1/02, pt continue to have hives whenever she stops the Benadryl. Pt also had 6-8 inch swelling at site of i1t dose given on 6/13/01 and 2 inch swelling at site of 2nd dose on 8/15/01
This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally (lot number and expiration date were not provided) for prophylaxis. It was reported that, ROTATEQ, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA002381: US-009507513-1705USA002380: US-009507513-1705USA002383: US-009507513-1705USA001712: US-009507513-1705USA002384:
An unknown number of pts were vaccinated SC with varicella virus vaccine live. One week post vax, the pts experienced a bump and redness at the injection site.
Large Red oval on arm near over and expanding from where vaccine was given. The entire area is sensitive to the touch.  Also had chills, hot flashes and sweats 10-20 hours after the injection, and a severe headache.
Fever (103), diarrhea -4 days after vaccine. Diarrhea continued x 1 week, now loose stools.