chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really bad bleeding nose; really bad bleeding nose; dizzy/lightheaded; light headache; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0185) as 1st dose, single for COVID-19 immunization. The patient's medical history included bleeding nose. The patient's concomitant medications were not reported. The patient experienced really really bad bleeding nose at about 2:30 and he was dizzy on 19May2021. Mother did not know that if that came with shot or he had not had bleeding nose in years. Patient with no other symptoms. He was dizzy and lightheaded and then that the bleeding nose. When probed ongoing for the adverse effect: Mother stated, Nose bleeding was almost gone but he felt light headache and dizzy. Events seriousness were provided as unspecified by reporter. No treatment received for events. Schedule date for the second shot was von 09Jun2021. The outcome of events was unknown.
Within about 20 minutes post injection, patient stated she felt "itchy". I gave her diphenhydramine and she swallowed it. At about 30 minutes post injection, she stated she had small bumps on her bilateral arms. They were hard for me to discern but she also claimed the bumps were painful.  I asked about any labored breathing or chest tightening and she denied both. After about ~45-50, she still stated the same itchiness and pain. Visually there was no change in my opinion. Patient then conferred with  supervisors at her employment about her next steps. Her PCP was closed and she was deciding if she wanted to go to urgent care. That's the last interaction I had.
Within a few weeks of receiving the Moderna COVID vaccine, I began to develop very noticeable floaters in my eyesight which were not present prior to receiving the vaccine. It has now been about 7 months since receiving the shots and they are still present in my eyesight. I have also developed a degree of light sensitivity and what feels like pressure around the eyes, especially my right eye. I also seem to have developed a bit of chronic fatigue as well as joint pain. The eye floaters are among the most stressful adverse effects however.
pt recv vax in 1986 & 1989 pt donated blood & was notified of a repeatedly pos core antibody; lab eval in APR94 revealed anti-HBs 128.1 & pos core antibody; No further details were provided;
Received H1N1 on 1/26/10 @ 15:45. 1/27/10 about 1000 developed headache, fatigue congestion, sore throat. 1/28/10 afternoon, red puffy under eyes and hives front and back of trunk. Called HCP who advised BENADRYL. Hives resolved by 1/31/10.
My wife and I received the first dose at Health Department on Monday, 02/01/2021 at about 2:15 PM.  Very well conducted process without any problem.  Wife has had no effect beyond sore arm, as have I.  In October I had the virus.  My temperature rose from my normal 97.6 up to 100.4 over about 3 days and stayed up for a couple of days.  I took one Tylenol.  My temperature dropped.  For the next week I had moderate diarrhea.  After my vaccine Monday, Tuesday morning I began having knee and upper thigh pain.  My temperature began rising.  In about 5 hours it reached about 101.2 for the rest of Tuesday.  By this morning (Wednesday) I am near normal with just some tiredness.
This spontaneous report was received from a pharmacist referring to approximately 63-year-old female patient. On 23-DEC-2013 the patient was vaccinated with ZOSTAVAX vial (lot # J004599, expiry date: 18-JUL-2014), single dose, subcutaneous, for vaccination. No other concomitant therapies reported. On 23-DEC-2013, the patient experienced hard lump at the injection site. The lump resolved within 1 hour without requiring medical treatment. There were no lab diagnostic tests performed. The action taken was reported as not applicable. The patient sought medical attention by visiting the pharmacy. There was no significant disability or inability. The event was not life threatening. There was no hospitalization, no overdose and no PQC was involved. The outcome of hard lump at the injection site was reported as recovered on 23-DEC-2013. The casualty of the event was unspecified. No further information provided. Additional information is not expected.
Pt. was here with mom, dad and two siblings to receive vaccines. He was due to receive Pentacel and Pneumococcal vaccines. After the appointment was over it was stated by mom that he had received the wrong vaccines, he had received MMR, Varicella and Kinrix. The health department was informed and there were no contraindications for the child, he would just have to receive vaccines that he needed which was HIB. Mom was informed of the results of this converstaion. Pt. did not have any type of known reaction to the vaccines he did receive.
A non-serious report of fever, runny nose, and right foot limping and dragging has been received from a physician concerning a three-year-old male. This case is submitted in accordance with MedImmune's post marketed commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST on 18-Oct-2008. On 18-Oct-2008, the patient was administered FLUMIST at a local pharmacy. On the evening of 19-Oct-2008, the patient developed symptoms of fever and runny nose. On 20-Oct-2008, the patient exhibited symptoms of limping on his right leg and dragging of his right foot. The patient did not complain of pain and was not hospitalized but was seen by a physician however, after being examined by a physician's diagnosis could not be determined. X-rays and neurological work up were performed, results were normal. The reporter confirmed that the patient did not fall or experience any incident which may have affected his leg. The patient's father, who is also a physician reported the neurological events in his son and requested additional information on the product. Per the report, his son was doing well, the event improved but was still ongoing. The causality was assessed as not related but the reporter believes that there was a temporal association.
n/t arm and leg immediately  after vaccine- numb /ting arm on follow up call next day.  Pt felt immunization was administered too high on arm/shoulder.   1/25 pt is to get dose #2 this week and concerned re: still some numbness but also some ringing in the ear.   Tells staff has had some ringing in the ear previous to vaccine mostly at night- this has now intensified to where she is also hearing it during the day.   She has d/w her PCP- she is very unsure if she should get vaccine #2 or not.
MORE SICK THAN BEFORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 more sick than before. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of more sick than before was not reported. This report was non-serious.
Received Moderna vaccine, approximately 11:40AM. Onset of throat fullness, tongue fullness about 12:30 PM Mild difficulty swallowing associated. ANAPHYLAXIS, INIT -     diphenhydrAMINE Injection 50 mg (BENADRYL) -     EPINEPHrine (ADRENACLICK/EPIPEN) 0.3 mg/0.3 mL Injection AutoInjector; Inject 0.3 mL intramuscularly as needed for severe allergic reaction . Inject in upper thigh -     predniSONE (ORASONE) 20 mg Oral Tab; Take 2 tablets by mouth daily with a meal Mild reaction. Improved with PO Benadryl. Reviewed home care, handout provided. Home epi prescribed. Prednisone 2 day course.
Narrative: 73-year-old M with history of hyperlipidemia and T2DM who presents with two days of palpitations, SOB, tachycardia, and dizziness. Patient reports palpitations and a sensation of heart racing that began 12 hours into his drive back from trip. On arrival home patient continued to have palpitations while ambulating and intermittently felt lightheaded and dizzy, although denies ever losing consciousness. Denies any lower extremity pain or swelling. He denies any personal or family history of PEs. No recent illness or procedures. No personal history of malignancy, although per PCP note patient has never had colonoscopy. On arrival to the ED, patient was afebrile, HR initially 127 although decreased to 80s within several minutes without intervention, BP 140s/80s, RR 12-15, maintaining O2 sats on room air. Labs were significant for D-dimer 17.19, troponin 0.03, BNP 2708. CT PE revealed bilateral segmental and subsegmental PEs with evidence of right heart strain and patient was started on a heparin gtt and admitted to MICU for further management.
Has allergy with prior reaction to sulfa drugs that she had the same symptoms of warmth and then developed hives. Her left upper extremity was warm to the touch when compared to her right, which was where she received her injection 20 minutes prior. Treated with motrin and benadryl 50mg po and symptoms resolved.
This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-AUG-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 intramuscularly, lot # M038216, expiration date reported as 09-MAY-2018 (exact dose and anatomical localization were not provided). No adverse effect was reported.
24 hours after vaccination patient developed fever, chills and diarrhea, as well as 4x2.5 cm painful erythematous area at injection site. Treated at work site by RN with tylenol, benedryl and local ice pack.
Pt recvd Engerix-B vax 10JUL92 & exp burning sensation when able to urinate; also has trouble urinating @ all;
Uncontrolled psoriatic arthritis symptoms and resurgence of Ehlers-Danlos symptoms: hot flashes, moderate to severe joint pain, mild fever, muscle weakness, mild confusion, increased instability in hip joints; all previously well controlled. New symptom of moderate to severe nausea and dyspepsia after Otezla dose. Tolerated Otezla previously without problem. Also, previously controlled deficits stemming from vertebra artery dissection in 4/2018 had mild resurgence: slight foot droop, confusion, communication errors ie: lost words, and left side weakness.
Within 5 minutes of receiving the vaccine, she noticed a gradual decreasing of hearing in her left ear.  It sounded like when you have an ear infection when you cannot hear, without any popping or changes by positioning. No pain, but imbalance/dizziness which sent her to a clinic. She feels that she lost about 80-85% of her hearing on the left side. She was told that she had fluid in her ear - to go home take a decongestant and nasal spray. At 3 days, there was no improvement, so she went to her PCP. They examined her ear and did not see any fluid, but referred her to an ENT MD. As it would have taken more time to get in to see an ENT, she made an appointment with an audiologist. She saw the audiologist on 3/17/2021. Her hearing had returned by this time. The audiologist said she had seen several patients who had experienced hearing loss and about 50% had not had their hearing return. This client's hearing tested above average at this time.
Red knot noted on left deltoid- 2" with a small purple dot noted in the middle of injection. Small white bumps were noted starting at red knots and going down arm in 1 inch strip to the elbow, No fever, Knot warm, Cool compress applied
Racing hard beeping heart. Heart felt like it was going to explode. The nlmorning after. Then Vomiting for 6 days. Heart still hurts and feels like its beeping weird. Its been a week and my 8 yera old.boy.is still down and needing more testing.
High pitched screaming/crying un-consolable for over 3 hours, very lethargic, unable to focus eyes.
had to use a wheelchair to go to the doctor's office; The physician reported on 10/30/2019 the patient experienced difficulty getting out of bed; pain in the right upper extremity; issue with lifting the right arm; myalgia; This spontaneous information has been received from a physician via company representative, concerning a 94-year-old female patient. The patient's pertinent medical history, concomitant medications and previously drug reactions and allergies were unknown by the reporter.  On 29-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in her right arm as prophylaxis (reported as preventive care) (lot number: S006777 with expiration date 28-NOV-2020) (dose, and strength were not provided; route of administration was unknown by the reporter). The patient did not receive any concomitant vaccines that day.  On 30-OCT-2019, the patient experienced difficulty getting out of bed (dysstasia), myalgia, pain in the right upper extremity (pain in extremity), an issue with lifting the right arm (injected limb mobility decreased) and had to use a wheelchair to go to the doctor's office (wheelchair user). The patient sought for medical attention; however, it was unknown by reporter if any laboratory diagnostic or studies were performed or if the patient received any treatment due to the events. The patient fully recovered from the abovementioned adverse events on an unspecified date in 2019.  The causal relationship between the abovementioned adverse events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, wheelchair user was determined to be a disabling event.
Fever (100.4 F), chills, severe headache, fatigue, achiness
After the second vaccine on 1/3/22 within 30 minutes I had upset stomach (diarrhea) and have had it every day since. I also developed blue legs on both legs from the knee caps up to the top of my thighs on 1/9/22 and again on I believe January 11th or 12th. That subsided but the diarrhea continues. I've been tested for many different intestinal issues, c diff, rotavirus, parasites, etc. etc.. All tests have come back negative.
On May 18, 2022  I started to feel bad had a sore throat. On May 20, 2022 I took a home COVID-19 Test that came back positive, so I went to were I volunteer, to take a PCR COVID-19 Test. They called me back to tell me the COVID-19 Test came back negative but I tested positive for  Influenza A. I was instructed to quarantine for five days and take over the counter medications.  On May 25, 2022 I took a home COVID-19 Test that came back positive. I went back to retake the COVID-19 Test. I was called back later and informed that I was positive for COVID-19 but no longer positive for Influenza A. They recommended Mucinex and over the counter cough syrup. I got an UTI from the Mucinex and had to be prescribed Nitrofurantoin. I was instructed to start taking  Coricidin HBP but I ended up with extreme head and chest congestion. I ended up with a nose bleed that resulted with me having to go to the emergency room and having to get a balloon up my nose to stop the bleeding because I am on blood thinners. I will be seeing an Ear Nose and Throat Specialist this Friday to remove the balloon.
malaise; body ache; positive home test on the first day i felt sick; positive home test on the first day i felt sick; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 03May2022, outcome "unknown", COVID-19 (medically significant) with onset 03May2022, outcome "recovered" and all described as "positive home test on the first day i felt sick"; ILLNESS (non-serious) with onset 03May2022, outcome "unknown", described as "sick"; MALAISE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body ache". The events "positive home test on the first day i felt sick", "sick", "malaise" and "body ache" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) positive, notes: I had a positive home test on the first day/felt sick, 03May; (13May2022) Negative, notes: I has a negative home test on 13May; (16May2022) Positive, notes: On 15May I woke up very sick and on 16May I tested positive; (19May2022) positive, notes: I stayed very sick through 19May when I tested positive again; (24May2022) Negative, notes: I tested negative on 24May. Therapeutic measures were taken as a result of covid-19, illness, malaise, pain.  Clinical course: Patient was exposed to Covid by a family member and became sick 3 days later with malaise, body aches, sore throat, runny nose and diarrhea. Patient had a positive home test on the first day/felt sick, 03May2022. Reported issues occur after use of a Pfizer product. Patient received treatment for Covid-19 illness and positive test with Ritonavir (Paxlovid) from 03May2022 to 08May2022 (5 days of 2-3 pill dose per day).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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
Information has been received from a physician concerning one of her patient's parents who heard that a female patient, on an unspecified date, received a dose of GARDASIL injection (Lot#: not reported) and she became paralyzed. The physician stated that it was not one of her patients. The outcome of the patient was not reported. Paralysis was considered to be disabling. No further information is available.
Headache's, Leg pain with trouble ambulating, right arm pain, fatigue, stomach pain, low energy. Intermittent
2 days after the vaccination a mild sore throat tiredness was felt. As time went on other flu like symptoms appeared. Sneezing, headache, fever, chills, congestion yellow thick sputum by the tenth day!!!
BRIGHT RED FACE, FACE RASH, SEVERE HEADACHE, FULL BODY ACHES, NO TASTE, FATIQUE
Reported chilling and redness, swelling at the shot site, 5" X 6".
Information has been received from physician concerning a 36 month old male with a history of eczema who on 05-Jul-2007 was vaccinated with MMR II (Merck) (lot# 656716/0161U, subcutaneous injection in the left side). Concomitant therapy included poliovirus vaccine and tuberculin purified protein derivative. In the evening of 09-May-2009 the patient developed shingles. He had red bumps that appeared on the back of the left arm that were a little itchy. On 10-May-2009 the bumps spread further down on the left upper arm. 1 spot posterior axillary fold 3cm in diameter. 2 spots in axilla that are 1 cm in diameter. The spot on the anterior chest is 2 cm in diameter and it is above and medially to the nipple. Another big cluster is on the left upper back that are 3-4 cm in diameter that are on the left of the spine. All spots are bumpy, almost vesicular rash. On a dermatome chart the spots fall exact on T2 to T3 dermatones. He visited the office and was treated with ZOVIRAX. At the time of reporting the patient was not recovered. The physician believed intervention to prevent serious criteria is giving ZOVIRAX. No further information is available.
This spontaneous report as received from a consumer as part of a marketing research program refers, to a 70 year old female patient. Approximately in February 2011, reported as 3 years ago, the patient was vaccinated with ZOSTAVAX (lot#, dose, strength, frequency, route not reported). Approximately in February 2011, reported as one day after the vaccine (about 3 years ago) the patient experienced slight rash on left shoulder which went away after 3 days (also reported that after 2-3 days). It was reported that the shoulder was also swollen for that time. The outcome of both adverse events was reported as recovered with sequelae (approximately in 2011). Relatedness between the events and the ZOSTAVAX was not assessed by the reporter. Additional information is not expected.
This spontaneous report as received from a nurse practitioner refers to a 60 year old female patient with none pertinent medical history, drug reactions or allergies. On 24-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous in the left arm). There was none concomitant medication. On 24-OCT-2014, the patient experienced swelling, redness and warmth at the injection site in her left arm after receiving ZOSTAVAX. The patient was treated with an unspecified steroid shot. None lab diagnostics studies were performed. The patient sought medical attention via visiting an office. The outcome of swelling, redness and warmth at the injection site in her left arm was reported as recovered (date unspecified). The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information has been requested.
received an expired dose.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Bexsero and Bexsero 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: 29-Jul-2022 Reporter's comment: The registered nurse reported that on the day of reporting the patient received an expired dose of Bexsero. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.