chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient states she had a lot of fluid on her lungs; she stated that she started having a consistent fever for 21 days and trouble breathing in early April after receiving her last dose of the Pfizer covid vaccination; infection; she stated that she started having a consistent fever for 21 days and trouble breathing in early April after receiving her last dose of the Pfizer covid vaccination; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reports a current hospitalization for what she says are COVID 19 vaccination side effects/issues. She stated that she started having a consistent fever for 21 days and trouble breathing in early April after receiving her last dose of the Pfizer COVID vaccination. Patient was admitted on 12Apr2021 because she could not breath. Patient states she had a lot of fluid on her lungs, and the doctor pulled it off and she is breathing better. Currently in the hospital on antibiotics and pending testing to see where the source of the infection may be. Patient has stopped all medications temporarily in an effort to identify the source of the current issue of fluid buildup on her lungs. The patient was hospitalized for pulmonary oedema and dyspnea from 12Apr2021 to an unknown date. Therapeutic measures were taken as a result of the events. The outcome of the event dyspnea was recovering while for the rest of the events was unknown.  Information on the lot/batch number has been requested.
3/17/08 Zostavax given.  3/18/08 Right side of head painful & "burning".  3/20/08 Right side of face Bell's palsy.  Medical office visit 3/24/08.  03/26/2008 MR received from PCP for OV 3/24/08 with c/o burning pain on the R ear and R-sided head pain x 1 week. On ~3/20/08 pt noted R side of face and eye drooping. R eye watering. DX:  Bell's Palsy
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was  diagnosed acute illness at the time of vaccination and or up to one month before. It was unknown if patient was having chronic or long standing health condition.     On 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 25 years and 9 months. No concomitant medication information was provided. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Patient received third dose of vaccine. Moderna vaccine Ndc code was reported as 80777-0273-99. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.   No treatment medication information was provided.
Information has been received from a licensed practical nurse (LPN) concerning a female employee who was vaccinated "in the past" with Varivax by another health care professional. In 2006 a recent varicella titer was negative for seroconversion. Additional information has been requested.
Initial unsolicited case received from a pharmacist on 12 Oct 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847.2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: UI669AA Expiry date: 30 Jun 2017 dose and site of administration was not reported) intramuscularly on 04 Oct 2016. The patient medical history illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. And any other vaccinations within four weeks of vaccination was not reported. The patient concomitant medications were not reported. On an unknown date and time frame after the vaccination the patient right arm bothered and little fever. The patient required emergency room (ER) visit. The patient lab tests and corrective treatment was not reported. The outcome of the events were unknown at the time of this report. List of documents held by sender: none.
Beginning Friday night, pain in arm, shoulder only. Saturday used arm as normal, but in the evening became increasingly painful - 6 out of 10. Sunday morning unable to lift arm without severe pain - 8 or 9 out of 10. No known injury, only event was booster shot. Pain lasted two more days, then eased up on wednesday. Doctor said it was likely bursitis. I've never had these symptoms before.
Day 8 developed red rash to arm at injection site that worsened in size and continued until Day 10/11 and resolved completely. No itching or pain.  I'm a physician so I just applied hydrocortisone cream and took benadryl.
Started off as a dime sized red mark at the injection site. Has since expanded to the size of an egg. Warm and sore to the touch. Arm was sore initially. Now only slightly tender when moving arm.
Patient came in 12/11/18 complaining that she had pain (soreness) in her arm for 2 weeks after the immunization. She no longer had the symptoms when she came in to tell us about it.
Headache, stiff/sore neck, all over muscle pain. Injection site swollen, hot to touch. Pain.
Information was received from a physician and a medical assistant concerning a 12 month old white female, with no known drug allergies and a (questionable rash on amoxicillin), who on 10/25/00 was vaccinated intramuscularly with the 1st dose of varicella virus vaccine live. The medical assistant reported that on approx. 11/4/00, the injection site was inflammed. The physician reported that on 11/4/00, the pt developed "redness" (Other Medical Event), "heat" (Other Medical Event), "2 pustules on skin at site of injection" (Other Medical Event), "with induration" (Other Medical Event). The pt was seen by the physician on 11/6/00 and on 11/8/00 and the inflammation was still present. The physician reported that the pt recovered from her experiences on 11/12/00. No further information is available.
Lower extremity muscle pain began a few hours after injection. Began in R gluteal region and progressed down to R calf by evening. Following a night of rest, I awake to both LEs having significant muscle soreness and multijoint aches throughout the upper body and bilateral knees.
My side effects turned right into shingles/suspected vaccination failure; Shingles; aching at the spot my shingles were, then it turned into Pain.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient stated that side effects are tough. The patient's side effects turned right into shingles, had aching at the spot his/her shingles were and then it turned into pain. The patient stated that surely they would not have that problem and get to the physician if they notice a rash. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102623:same reporter
COVID MULTIPLE TIMES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid multiple times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid multiple times was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000263873.
I was diagnose with COVID one week after my booster vaccine. I felt flu-ish and I did not feel right. On Friday I got the results that I was positive. I have a cough, persistent, body aches and headaches. X-ray of the chest was performed along with a COVID test. I also had some hard time breathing at night but it seems to have pass. I just haven't felt right ever since getting COVID.
Patient was administered 2 doses of the diluent instead of 1 dose diluent + 1 dose SHINGRIX. Reported soreness at site of administration.
the patient was administered an improperly stored dose of PEDVAXHIB; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.      On 12-DEC-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # S006471 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 22-JAN-2022) for prophylaxis (strength, dose, anatomical location, and route of administration were not reported).  The dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), was exposed to a temperature excursion of 48.5 degrees Fahrenheit (°F) during a time frame of 1 hour, which was detected by the data logger. There was no prior temperature excursion.
1st day p/inject little red spot; 2nd day worse & kept getting worse 4 days p/inject; red raised area 3 in that is part rash & part hive; also exp knot;
PATIENT CALLED SAYING SHE HAS HAD 3 DIZZY SPELLS  SINCE 4 PM TODAY (7/14/2021).  SHE ALSO REFERRED TO THEM AS FEELING LIKE IN A TUNNEL.  THE FEELING IS NOT CONSTANT.  SHE FIRST STARTED WITH FEVER, DIARRHEA, VOMITING ON 7/11/2021 AND HAS FELT "OFF" SINCE THEN.  I ASKED HER IF SHE THOUGHT SHE NEEDED TO BE SEEN BY A DOCTOR TONIGHT, SHE WAS NOT SURE.  I THEN SAID SHE SHOULD BE EVALUATED BY A DOCTOR TOMORROW WHICH IS 7/15/2021.
Severe localized rxn @ rt deltoid inject site of 5-7 days duration. Did not consult MD. Treated w/Analgesic & warm compresses.
Pfizer  EP7S5S     adverse event:  Left arm, at the site of the injection, became swollen, fairly   hard, hot tp the touch, and painful.    The next day it hurt more, and the next day hurt even more.  hurts to move the arm.
I was driving home from the clinic and began to feel my throat closing and having to drink and swallow. I reached home and my husband asked if I was okay. I stated that I felt my throat closing and my chest was feeling heavy. He took me to Urgent Care  and they took me by ambulance to ER after I was given nitro at the Urgent Care and was given 150mg Benadryl in the ambulance. When in the ER I was given both oral and IV Prednisone which totaled 350 mg. I was monitored in the ER for 6 hours and an ECG was done with no indication of issues. I was sent home with an oral Predisone script which I proceeded to take for the next 10 days. i began to experience extreme fatigue which continues to this day. Along with the fatigue I have joint pain and swelling which is mainly in the knees and shoulders. Approximately 4 months later, I began to have nausea and vomiting daily when attempting to eat any meal during the day. With this new set of symptoms, I became bedridden for the next 5 months and unable to eat or even drink without vomiting which caused issues with my chronic conditions of my diabetes and high blood pressure as well as my osteoarthritis.  I was able to get a medication of Omeprozale from my physician in the beginning of December which helped to stop the nausea and vomiting. As time has gone on, I continue still with the fatigue which at times has come on without warning and keeps me from activities unless I rest for at least an hour.
PT with chest pain and SOB since the day of vaccination; this was the 2nd COVID vaccine. First dose 22May2021 with no reactions.
Mouth pain and lip pain the evening of the vaccine; woke up Saturday morning with blisters on lips. Painful to eat and/or drink, but no difficulty swallowing or c/o sore throat.   At office visit on 11/6 (when she received the Flu vaccine) we had applied Canthacur on warts on her left thumb and finger and the Dr. felt like she may have put her fingers near on her lips after that application which would have possibly caused the sores/blisters.
COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID infection".  Clinical information: Patient stated shareholder and 2x vaccinated, boosted with your vaccines. Why am I not to get the new booster for 3 months after COVID infection ends, patient asked.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
31 year old pregnant patient mistakenlyreceived Fluzone High-Dose; 31 year old pregnant patient to receive Fluzone High-Dose; 31 year old pregnant patient to receive Fluzone High-Dose; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 31 years old female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in context of 31 year old pregnant patient to receive Fluzone High-Dose (exposure during pregnancy), (product administered to patient of inappropriate age) and (overdose). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. Gestation period was unknown.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's previous pregnancy was unknown.  On 10-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  It was a case of vaccine exposure during pregnancy.  It was unknown if the patient had any adverse event.  The patient outcome is reported as Not Applicable for drug exposure during pregnancy.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  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.
Got shot on 1-11-21 and on 1-13-21 am was totally unresponsive , oxygen level low and passed away on 1-14-21
Day after shot, right side facial paralysis  Then changed to numb feeling around right eye and ache behind eye ?Pulling? at right eye Tightness of scalp Ear ringing Tenderness/pain, right side of head Dry eye Nausea (comes and goes)
Itchy throat, itchy tongue, itchy bottom lip, felt itchiness on outer back edges of ears and neck. The symptoms started 35 minutes after infection. They lasted for 3 hours.
Swollen lymph node under chin 1 week after first dose; Panic attack; Anxiety; Sweating; Lightheaded; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03May2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021, the patient experienced panic attack, anxiety, sweating, lightheaded immediately after the shot and on 10May2021,  the patient experienced swollen lymph node under chin 1 week after first dose. The events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events panic attack, anxiety, sweating, lightheaded and swollen lymph node under chin were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got this information from a phone call with her today.  This was five days after the injection and three days after starting a supplement African Mango. She was at work and felt cold all day and was drinking coffee all day Yes body aches and chills, "stomach was like a rock" and " whole body was hard like a rock"  It felt as if she had had a really hard workout. No ER, swelling of tongues, lips, eyes or trouble breathing.   Never had this before. She was seen in the clinic by and had advice from two providers including her "niece" ALLERGIES - tramadol causes nausea and shakiness. No food allergies or allergies to insects.  When she  took her bra off and her " breasts were standing up like rocks"  and her stomach was very hard and lumps over the back of her neck. Legs were the last muscle to relax. These symptoms dissipated after three days. She did not check her vitals. She was taking tylenol and drinking lots of water.   She reports her hands and feet were swollen and itchy.   I asked her to sign up the vsafe.cdc.gov. I will contact the CDC to report.
heard and seen that other people that had the same; 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 URTICARIA (heard and seen that other people that had the same) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (heard and seen that other people that had the same). At the time of the report, URTICARIA (heard and seen that other people that had the same) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 12th March 2018 09:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th March 2018, immediately after receiving SHINGRIX, the patient experienced tiredness. On 12th March 2018, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema, tiredness and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, tiredness and injection site pain to be related to SHINGRIX. Additional information was received as follows; The patient received SHINGRIX in the left deltoid. The redness and ache at injection site occurred 30 minutes after vaccination and were about 4 inches in diameter. They were not getting better when the patient reported it 2 days later. No actions were taken by the patient yet.
About two days after receiving the vaccine, pain and burning feelings from fibromyalgia returned.  They have been under control for several years under medication, but the medication has not helped, even with an increase in dose recommended by the doctor.  The pain seems to be getting worse daily.
Pt notified myself of delayed rxn to shingles vaccine - 3 days after the vaccine she noted a swollen, tender, itchy arm down to the elbow, which lasted and resolved after 1 week.  Pt reported no other problems.