chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had the shingles shot and still got them/Suspected Vaccination Failure; still got them.; I'm in my 7th week of pain/pain is steady day and night.; I feel like I have broken ribs; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the shingles shot and still got them/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still got them.), pain (Verbatim: I'm in my 7th week of pain/pain is steady day and night.) and rib fracture (Verbatim: I feel like I have broken ribs). The outcome of the vaccination failure was unknown and the outcome of the shingles and rib fracture were not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rib fracture to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and rib fracture to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 and 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and still got shingles.  The patient was in his/her 7th week of pain.  The patient felt like he/she had broken ribs and the pain was steady day and night. The reporter further stated that did not do him/her any good, still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
got a little swollen and now this morning with his chin; lips swelled up; eye got a little swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), via an unspecified route of administration on 12Mar2021 (at the age of 70-year-old) as dose 2, single for COVID-19 immunisation. Medical history included diabetes mellitus. Patient taking concomitant Products for Diabetes. Patient previously took bnt162b2 as dose 1 for COVID-19 immunisation. On 12Mar2021, the patient experienced lip swelling, eye swelling and on 13Mar2021, he experienced swelling. Friday night his lips swelled up last night his eye got a little swollen and now this morning with his chin. The outcome of the events was unknown. Patient took a Benadryl as a treatment drug.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Pain aggravated; Her right arm is still hurting at the injection site it hurts to sleep on it; Tired all the time; H Pylori; Diarrhea; This spontaneous case was reported by a nurse and describes the occurrence of HELICOBACTER INFECTION (H Pylori) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HELICOBACTER INFECTION (H Pylori) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and FATIGUE (Tired all the time). On an unknown date, the patient experienced PAIN (Pain aggravated) and VACCINATION SITE PAIN (Her right arm is still hurting at the injection site it hurts to sleep on it). At the time of the report, HELICOBACTER INFECTION (H Pylori) had resolved, DIARRHOEA (Diarrhea), FATIGUE (Tired all the time) and VACCINATION SITE PAIN (Her right arm is still hurting at the injection site it hurts to sleep on it) had not resolved and PAIN (Pain aggravated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was noted the patient's right arm was still hurting at the injection site it hurt to sleep on it, raise it, or sometimes doing simple things like reaching. She felt pain that is getting worse not better.  Treatment for the event of H Pylori included unknown antibiotic. No concomitant medications were reported.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A 12 year old was accidentally given a pediatric dose (0.2mL) of Pfizer vaccine.
Information has been received from a licensed practical nurse concerning 6 year old male with no past medical history who on 3/23/99 at 12:04 PM was vaccinated with a first dose of varicella virus vaccine live (lot # 628697/1838H), IM in the left arm. There was concomitant medication or illness at the time of vaccination. Subsequently, the patient developed mild case of chicken pox. On 5/1/04, the patient developed less than 50 lesions. It was noted that the patient had no fever. The patient recovered on 5/7/04. It was noted that the patient did not experience any adverse events following prior vaccinations. No product quality complaint was involved. It was also reported that other patients had a similar experience (WAES0406USA02563). Additional information has been requested.
They said this was the vacinne given. I do NOT know the manufacturer. I had my first dose in 1998, then in 2003, and then 2008. I thought I was done.. Dr. insisted at last visit for physical that I should do it again and one more time when I turn 65 in 5 years. Don't think I want to repeat this! Okay reaction - A few hours after injection, arm was so painful I could not lift it. It was warm/tender. Next day very painful, but tryed to keep it moving and used heat packs occasionally throughout the day. The 2nd day I woke up and my arm was itching up a storm. I went to scratch and felt lumps all over it. Went to bathroom and discovered several red lumps all over upper arm.  Some were as small as dimes and others the size of quarters. Went to dr. office and saw a nurse who prescribed steriods for 3 days and benadryl. Had hideous headache that I guess came from steriods so rested for 3 days. Now I appear to be fine after a miserable week.
RED RASH ON THE ARM WHERE SHE RECEIVED THE IMMUNIZATION WITH SEVERE ITCHING.
Upon second medical examination of the case during internal review, a significant correction was performed on 18 January 2016 to correct the suspect product from IMOVAX (IPV (VERO)) to IMOVAX RABIES (RABIES (HDC) VACCINE). Initial unsolicited report received from a consumer on 10 July 2015. A 52-years-old female patient, whose concomitant medication was not reported, had received a first dose of IPV (VERO) (Imovax) (batch number: J0404, expiration date, dose, dose number and route of administration were not reported) in left deltoid and also received a first dose of PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN (Imogam) (batch number, expiration date, dose, dose number and route of administration were not reported) in "Mult"on 9 July 2015. The patient's medical history reported as, penicillin, sulfa allergy, fluoroquinolone, latex allergy and MGUS (Monoclonal gammopathy of unknown significance) and Myeloma. On 9 July 2015, same day post-vaccination, the patient experienced a lump just below the site of injection and arm soreness. The patient did not have pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. Patient did not receive other vaccination within four weeks. The patient required ER/doctor visit. Laboratory investigation was none reported. The patient applied ice as a corrective treatment. At the time of this report, the patient was recovered from lump just below the site of injection but not recovered from arm soreness. List of documents held by sender: none. Addendum on 18 January 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 18 January 2016 to correct the suspect product from IMOVAX (IPV (VERO)) to IMOVAX RABIES (RABIES (HDC) VACCINE).
a patient received an expired dose of Adacel vaccine/ No AE; Initial information received on 28-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) via physician (Medical assistant/ practice supervisor) via phone via Agency number: 00700841.  This case involves a 27 years old male patient who received an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   List concomitant: No other vaccines.  On 28-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection lot number: C5577A, expiry date: 20-Feb-2021, Frequency: once, Strength: standard via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: unknown).  It was reported Medical assistant/ practice supervisor called informing that employee gave tetanus vaccine that expired in February 2021. I am wondering if it is ok to administer another. Reporter relationship: HCP Product used: Used and Still using product: No.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Redness, swelling, and heat to left upper arm. Itching, minor pain present. Redness and swelling extends  5-6 inches down arm, and ends just above elbow.
Severe fatigue, high fever dizziness nausea, diarrhea, rash on injection arm.
Abdominal pain, nausea, diarrhea, fever to 103, lactic acidosis to 3.9,
Pt became pale and diaphoretic after immunization, patient was assisted to a reclining chair with their legs elevated and a cool compress applied to face, Vital signs were stable 110/80 bp, 76 pulse, Respirations 17, no s/sx of respiratory distress, no hives or uticaria. Pt remained conscious, was alert and oriented. 911 was called and pt was evaluated by the Woburn fire department, the patient  refused hospitialization. Pt stated he was feeling better and went home.
On 5/4/06, received call from audiologist. Reports significant hearing loss, sudden onset noticed last 6 months; no conductive. Questions relation to MMR vaccine. #1 admission 5/96 after reports of adverse effects. #2 admission 8/99 (8/4/99) after call on 8/17/99 from mom reporting high fever - not seen by medical provider.
I had a stroke on April 3, 2021. Affected right side of body. arm, leg  and dominant hand and speech.
Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Jul2023 to 27Jul2023. Clinical Course: She took Paxlovid her first day of symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300267733 Same patient/reporter, different drug/event;
12/18 received injection  12/19- woke up at 0700 with fever,  spine pain-Lumbar region into the coccyx. Pain radiates down into hip joints and down bilateral femurs. Low grade fever most of the 19th. Nothing higher than 101. Arm soreness at the injection site, not bad, just sore. 12/20- fever broke around 11:00 am,  still having this weird bone pain in my lower spine and both legs. 8:00 pm, no fever, arm soreness gone. Still have the low back and leg pain.
Lt arm pain and paresthesias.  MRI obtained in Feb 2014 after failing conservative tx, consistent with sybacromial bursitis.
**NO LOT # WRITTEN ON HER CARD**  The day of the vaccine I felt tired and slept fairly well. I ended up waking up with a low grade fever and a little achy. The next day I laid low and didn't do much, this lasted about 24-36 hours. Then 11 days later I had a temperature and felt lethargic. I went to the clinic to get a Covid test and it as negative and the symptoms went away.
The patient presented to the ER the day following the vaccines. She reported to her primary provider that she was experiencing fatigue, nausea, and vomiting since she received the vaccine. She received IV fluids and ondansetron. When contacted by the pharmacy the patient stated she had kidney damage as well. As of 7/9 /21, she is still experiencing side effects.
Pt developed rash at injection site on 6/3/12 then developed "bumps the size of a dime w/ blisters in center" that itch on (R) side of body (ear, leg, arm) -> pt believes it is chicken pox...
received influenza and pneumonia vaccines on 10/30/07 at above mentioned facility between 2:00p and 2:30p. i had been experiencing leg pain that day and the day before, however on 11/1/07 when i awoke at approx 10:00a i experienced numbmess, acheing and needless and pins sensations in my legs and was having trouble walking. i had never had feelings like this in my legs before and it is worsening progressivly everyday. it is now 11/3/07 at approx. 5:00p. i am so off balance i am walking with an old cane we had to get around the house. i am going to the er at the clinic that gave me the shot on monday if this does not improve. if it does i will at least call and report this for their records. i am 55 and have never had a flu shot as i lived in california during the swine flu thing and my boyfriend was a dr's son. the doc recommended that we wait and see which we did and i guess i've been gun-shy ever since. i decided that i'd get one this year as they seemed harmless here lately. i have done some of my own research and believe this could fall into a gbs catagory but have not been to the dr. thank you
Discharge Provider:  MD Primary Care Physician at Discharge: DO   Admission Date: 11/28/2022 COVID positive 11/28/2022 PRESENTING PROBLEM: COVID-19 [U07.1] Acute respiratory failure with hypoxia and hypercapnia [J96.01, J96.02]   HOSPITAL COURSE: 89-year-old female with past medical history of coronary disease status post CABG in 2010, chronic obstructive pulmonary disease on 2 L chronically, hypertension, peripheral artery disease, OSA, severe pulmonary hypertension (ECHO January 2021 EF 60%, right ventricular systolic pressure 76 mm Hg).. Patient was admitted on November 28th for shortness of breath fevers.  Ultimately diagnosed with COVID-19 pneumonia.  Chest x-ray showed no acute process.  Patient was on 4 L of oxygen per nasal cannula, normally on 2 L.  Patient was started on steroids as well as remdesivir.  On December 1st patient developed acute CHF, transferred to the intensive care unit.  Placed on BiPAP, aggressively diuresed and has improved.  At that time she was also started on empiric antibiotics, Zosyn. She was then down graded from ICU and placed on high flow nasal cannula. She refused bipap. She agreed, along with family to become DNR/DNI. Patient continually declining. Spoke with family about hospice consult and comfort measures. They agreed to this, then wanted to wait initially with first consult. Ultimately as patient's respiratory status ultimately declined, family wished to place patient on comfort measures. Time of death was 1230 pm on 12/14/2022 with family at bedside.
Experienced light headedness ( started before time stated but not sure when exactly). Around 6:30pm-7pm I began feeling dizzy, going between dizzy and light headed. I was drinking plenty fluids and did eat. A few people noted that I looked very out of it, and I felt very out of it. I tried staying seated and this did not have any effect on the dizzy feeling. I went to lay down and before going to sleep around 10pm-11pm, laying in bed I felt like the room was spinning. I also had typical symptoms, soreness as injections site and arm (starting immediately the day of vaccine), fever at it's highest was 102 (starting at 100.5 that morning, not peaking until Motrin wore off*see below*), feeling tired and very heavy.. like everywhere was waited down by something (starting early in the morning).  I was given Motrin by my coworker in the morning as I was had a headache  and was feeling sore and moving sore due to heavy feeling. Wednesday waking up the dizziness  and lightheadedness were gone. A slight feeling of being out of it however, fever was about 99-100 throughout the day (99 being my typical temp). As of today only a feeling of sore arm and tiredness which sometimes feels like I and out of it but I feel both from later yesterday and today is due to the tired feeling that comes common.
Is not getting her menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Is not getting her menstrual cycle) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), VITAMINS NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    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 MENSTRUATION DELAYED (Is not getting her menstrual cycle). At the time of the report, MENSTRUATION DELAYED (Is not getting her menstrual cycle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included OTC Heartburn medication and Anti Anxiety medication. Patient stated that her menstrual cycle was pretty regular normally. No treatment information provided.
ABOUT 2 DAYS AFTER THE SECOND VACCINATION, THE PATIENT REPORTS THAT BOTH HEELS OF THE FEET HURT SO BAD TO THE POINT THAT SHE COULD NOT WALK. SHE WAS IN BED FOR 2 DAYS. SHE STILL FEELS THE PAIN TO THIS DAY BUT IT IS MORE BEARABLE SO THAT SHE CAN WALK. HER RIGHT HEEL HURTS MORE THAN HER LEFT HEEL NOW. SHE IS TRYING ACCUPUNCTURE FOR RELIEF BUT SO FAR IT IS NOT HELPING.
This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 12 month old male patient. No concurrent conditions or medical history were reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Child had hives on all 4 extremities, no flank or head.  No additional body system complaints.  VVS except for elevated pulse of 118.  Pt was assessed in the presence of mother.  They agreed to administer Benadryl 25mg po - brought to site by mother, given at 1710.  Child remained for full 30 minutes, rash subsided but did not disappear. No additional complaints/concerns noted.  Pulse decreased to 103 with no discomfort or distress. both reviewed indications for calling PCP and/or EMS.  Mother noted that pt's sister has anaphylaxis allergies and the family is well versed in management and has EpiPens.  Pt's MD was contacted following day and advised parents that she may receive the second dose of Pfizer.  Her symptoms have completely resolved with no adverse effects.
09/14/22 presents to ED for "weakness and confusion". PMHx of "HTN, HLD, diabetes, hypothyroidism"
I had the fever, and chills for about 2 weeks after my shot. I also had headaches. Then my previous ailment returned, but worsened. I have had congestion ever since.  I?ve been having thick sticky mucus that doesn?t seem to be getting better. The weakness, and fatigue have not gone away.
flublok vaccine was administered to 5 year old children with no reported adverse event; Initial information received on 09-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old patient of unknown gender who had administered Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine(form, route, frequency, strength, administration site, batch number, expiry date not reported) for immunization. Information on batch number was requested.  On same day following the administration of Influenza Quadrivalent Recombinant Vaccine it was reported that "flublok vaccine was administered to 5 year old children with no reported adverse event" (product use issue).  Action taken was not applicable.  Outcome was 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt developed right arm and neck pain, myalgia, swollen eyes, and rash.
Vomited within one hour.  Fever started around 5:00 PM.  Next day (9/24/11) no voice, coughing, fever. Following day (9/25/11) no voice, fever, diarrhea.