chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing loss; Left ear tinnitus; Hypotensive episode; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Hypotensive episode), DEAFNESS (hearing loss) and TINNITUS (Left ear tinnitus) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis, Hypersensitivity reaction and Urticaria. Concurrent medical conditions included Allergy to vaccine (Rabies vax(uticaria, anaphylaxis, received EPI)) since 1995 and Allergy to vaccine (Flu shot(lip swelling, cough, dysgeusia)) since 2011. Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) for Birth control.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced HYPOTENSION (Hypotensive episode). On an unknown date, the patient experienced DEAFNESS (hearing loss) and TINNITUS (Left ear tinnitus). At the time of the report, HYPOTENSION (Hypotensive episode), DEAFNESS (hearing loss) and TINNITUS (Left ear tinnitus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Acoustic stimulation tests: abnormal (abnormal) acute left sided sensorineural hearing loss. On 19-Apr-2021, Acoustic stimulation tests: abnormal (abnormal) acute left sided sensorineural hearing loss. On 03-May-2021, Magnetic resonance imaging head: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include  dexamethasone injection to left ear and started me on oral predisone and discontinued the diurectic.    Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Non-Significant follow up appended to AER
Drug ineffective; Have COVID several times; High blood pressure; Morbidly obese; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient 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; BNT162b2 (BNT162B2), 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), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Have COVID several times"; HYPERTENSION (non-serious), outcome "unknown", described as "High blood pressure"; OBESITY (non-serious), outcome "unknown", described as "Morbidly obese". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical Course: Patient had COVID several times, had high blood pressure and was considered morbidly obese. Patient had many health issues and had taken Pfizer for each and all of COVID shots including the booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Case developed COVID symptoms on 4/9/2022. Symptoms: Cough, wheezing, shortness of breath, congestion, fatigue, muscle aches, poor appetite. Admitted to hospital on 4/12/2022 and remained there until 4/14/2022.
she had pain in her upper left arm after the second Moderna Covid-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (she had pain in her upper left arm after the second Moderna Covid-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 023M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (she had pain in her upper left arm after the second Moderna Covid-19 vaccine.). At the time of the report, VACCINATION SITE PAIN (she had pain in her upper left arm after the second Moderna Covid-19 vaccine.) had not resolved.            The patient received her first Moderna Covid-19 booster vaccine on 2 Apr 2022 lot number 039F241, expiration date was not known. Patient received the vaccine in her left arm. Patient reports no adverse reactions or side effects.   The patient received a Moderna Covid-19 vaccine booster dose on 27 May 2022 lot number 054A22A expiration date was not known. Patient received the vaccine in her left arm. The chills started sometime before October 2022 but not know when.  The patient received her last booster dose on 15 Oct 2022. This vaccine was a Pfizer vaccine. Patient had a flu vaccine at the time of Pfizer vaccine.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730787 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730787:Same patient, different dose
Swollen, warm-to-touch at the site of the vaccine, fever of 101.0 degrees F, cloudy mind, sore neck/head, dizzy, symptoms lasted a total of 24 hours.
It started with right hip pain, moved to left hip, knees, joints in hands, swollen ankles, progressively worsening since 2nd vaccination, to date. Having difficulty walking. Was treated for Osteoarthritis and told it's part of aging. Saw orthopedic surgeon for hip replacement evaluation.  Said I was not advanced enough and he didn't know why my pain was so great. In September 2022, requested full blood panel to identify what is wrong and causing chronic joint pain. Diagnosed with Rheumatoid Arthritis in September,  2022, on top of existing Osteoarthritis. Started Methotrexate. Taking Ibuprofen for chronic pain.  In the time since 2nd vaccination, I have tried chiropractic, nutrition and supplemental therapy, Acupuncture,  physical therapy,  muscle relaxers,  Prednisone taper, CBD, Diclofenac, Tramadol with worsening symptoms since onset in May 2021.
I have been affected by Dizziness and Vertigo since 4 days after my second dose of the COVID 19 vaccine
Prior to 05/01/2021 I started to notice reduced urinary flow and it started getting more noticeable around 05/01/2021. I went to see Dr. on 06/29/2021 at 10:30 am., and she prescribed Tamsulosin .4 mg od. I have also noticed a small rash on my forehead, that is itchy, it's not red, but it doesn't seem to be going away.
Abnormal vaginal bleeding. Last menstrual cycle was 4/3/21, next one scheduled for 5/2/21, cycles are described as very light. On 4/16/21 at 4:00 pm clumpy bleeding started and continues through today 4/19/21.
herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. The patient was vaccinated with zoster vaccine live (ZOSTAVAX) (vaccination date, strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event herpes zoster to be disability.
Severe swelling, tenderness and warmth at injection site accompanied with nausea, headache & dizziness.
First dose Oct 2019, can the series be continued or should it be restarted?; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Approximately ten hours after the vaccine, I began having what I consider an extreme reaction. Intense body aches, chills, headache, fever, sweating, and general feeling of being very unwell. Along with the expected symptoms, I had shaking that was not just from having chills, rapid resting heart rate that was running well above 100. My normal resting heart rate is in the 60s and sometimes even 50s.  I also had a feeling of "deep, intense cold."  The symptoms gradually eased after the first 24 hours but persisted enough that I was in bed for three days.  After the three days, I struggled with extreme fatigue and felt like I was always freezing cold. I was also having strange changes in my heart rate.My heart would race and then slow down again. After about three weeks, I began to have palpitations which continued to get worse over the following months, especially with any exertion. The fatigue and cold feeling lasted for a few months, and my hands were always ice cold. I am still having the palpitations/arrhythmias. Around April, I felt like I was getting out of shape because of the fatigue and inability to do what I normally did. I decided to start increasing my activity, walking exercising, etc. in order to combat the fatigue and "get back in shape." This caused an increase in my palpitations, chest discomfort and shortness of breath which caused me to go home from work a few times and to seek medical attention. I was unable to get right in to see a doctor so I purchases a device for my tablet so that I could try and capture what was occurring and show the doctor. I eventually saw my GP and was referred to a Cardiologist. I was having PVCs. and at this point I had on average eight per minute with episode of many more at times. This has continued and fluctuates in intensity. I think maybe it is slightly improving but sometimes I still have episodes of increased arrhythmias so this is not resolved and is still continuing and limiting my normal activities. The cardiologist ruled out Mi or ischemia as a cause. We believe there is inflammation in the heart muscle. I should note here that prior to this I have never had any problems with my heart. Not even high  blood pressure.
Rash; Shingles; This case was reported by a consumer via(Shingrix ) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On 19th July 2021, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient had the 1st Shingles vaccine, but didn't get the 2nd shot due to surgery and amp; more. The patient got shingles on 19th July 2021. The patient was told that the patient need 1 shot and amp; when the patient's rash had completely gone.
Injection site started out with a bean size red mark and grew to a grapefruit size swelling mark with pain and joint discomfort.
Twitching; involuntary muscle movement on right side of face in cheek area. Guest complains of feeling of pulling/twitching going down from right eye to right cheek on face.
However, for the booster dose, she said that she was so depleted that she can't get out of bed. She also mentioned that she is immunocompromised.; However, for the booster dose, she said that she was so depleted that she can't get out of bed. She also mentioned that she is immunocompromised.; she was depleted; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Caller has the 2 Pfizer COVID-19 vaccines and she said that she had no problems except for a slightly sore arm.), for Covid-19 immunization, reaction(s): "slightly sore arm"; Bnt162b2 (Dose 1, Caller has the 2 Pfizer COVID-19 vaccines and she said that she had no problems except for a slightly sore arm.), for Covid-19 immunization, reaction(s): "slightly sore arm". The following information was reported: IMMUNODEFICIENCY (medically significant), BEDRIDDEN (disability), outcome "unknown" and all described as "However, for the booster dose, she said that she was so depleted that she can't get out of bed. She also mentioned that she is immunocompromised."; ASTHENIA (non-serious), outcome "unknown", described as "she was depleted".  Clinical course: It was reported that, patient has the 2 Pfizer COVID-19 vaccines and she said that she had no problems except for a slightly sore arm. However, for the booster dose, she said that she was so depleted that she can't get out of bed. She also mentioned that she was immunocompromised. She wanted to know if the formulation for the first 2 dose, 4th dose, and the booster dose have the same formulation. She also mentioned that she know other people who didn't have a problem with the first and second dose. They were so chill and under covers. For some reason, the booster shot was not good because she had a reaction to that.  The lot number for bnt162b2 was not provided and will be requested during follow up.
patients received expired doses of Flublok Quadrivalent/No AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from other health care professional.  This case is linked to cases 2019SA316777, 2019SA316760 and 2019SA316778 (same reporter).  This case involves a 57-year-old male patient who received expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1824, expiry date- 30-06-2019) via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  At the time of report 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 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 recv vax on 12/15/98; on 12/16/98 pt exp fever (104.5), febrile seizure
Low-grade fever, chills, nausea, headache, joint and muscle pain, unrelieved by TYLENOL, for 36 hours. Pain at injection site with left axilla lymphadenopathy. Unable to work X 36 hours.
5/2/2022 @ 1430 an incomplete MMRV vaccine was administered. Client jerked and pulled away and the full 0.5 ml was not injected. Contacted public health office Dr. and informed him of the incident. Per Dr. - administer another 0.5 ml dose since we can not be sure how much of the original dose was actually administered.  Second dose administered 5/2/2022 @ 1450. Client monitored for adverse reactions, none to report. Parent/Guardian of client instructed to contact EMS if a severe reaction is witnessed.
Around 2 hours after the vaccination, her Right arm felt numb down to the fingertips. It lasted roughly 3 hours and then went away and did not return.Patient then felt weak and achy as if she had mono for a couple of days and then was back to baseline by 7/24/2011.
My wife became symptomatic 3 days following a social encounter; I became symptomatic 3 days following her first symptoms. My first symptoms in the evening involved irritation and secretions beginning in my throat and developing into upper respiratory secretions, aches, and fatigue. Tested positive the next morning with Covid-19 home test kit. I made a virtual meeting with my primary physician that advised me that I qualified for Paxlovid. I started a 5 day course of Paxlovid and my symptoms improved daily. I was asymptomatic before completing the 5 day course of Paxlovid.
8 days after receiving vaccine my arm swelled up, got red, & itched around the site of the injection
patient received vaccination at 9:29am.  She was asked to sit down and wait for 15 minutes post vaccination.  Patient and grandmother left after 5 minutes.  she had a brief fainting episode at the front door of store.  She came back to pharmacy and was observed for 30 more minutes, she felt fine and then left the pharmacy
Patient complained of a head ache, right arm hurting, and a low grade temp of 99.7 and 99.1 on Tuesday morning 7/14/20 after receiving the 2nd Men B dose on 7/13/20.   He then took 400mg Ibuprofen and then took his brother to football practice.  Once he got home he notified his mother that he felt some motion sickness when he was driving home. When she asked him further, he said "if he stands up too fast he feels dizzy".  Mom states that he is not one to complain.   Mom did call back later that afternoon and said that patient's fever is gone and is headaches are not as bad anymore.
Not an adverse effect. Patient received 2nd dose of Moderna off-label per new CDC Guidance, after getting the first one as a medication error on 1/23/2021. Patient suffered no ill effects after vaccination.
Mouth rash at gum line and painful underside of tongue. Mild soreness from the arm, not as sore as first injection. Mild headache.
approximately one week after receiving the first dose, i started having tingling in my left arm which the vaccine was administered. tingling occurs between the elbow and the injection site and if often accompanied by numbness and weakness. at week 5, the sensation of tingling and numbness continues in the left arm at the same severity.
Extremely sore shoulder, headache, stuffy head, body aches and nausea.
Patient was incorrectly given the inactive agent/dilutent of  Shingrix vaccine. Fortunately, no side effects.
No appetite; Brain fog; Lot of exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), FEELING ABNORMAL (Brain fog) and FATIGUE (Lot of exhaustion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, LEVOTHYROXINE, PROPRANOLOL and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DECREASED APPETITE (No appetite), FEELING ABNORMAL (Brain fog) and FATIGUE (Lot of exhaustion). At the time of the report, DECREASED APPETITE (No appetite) and FEELING ABNORMAL (Brain fog) had not resolved and FATIGUE (Lot of exhaustion) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
A few minutes after the vaccine was administered, she developed tingling in the back of her head.  A few mintues later she developed tachycardia (she did not wait the 15 minutes she was supposed to wait before moving).  Her heart was racing in the 120s. About 15 minutes after the injection, she started having a tingling sensation in her left face. About an hour (maybe two hours) after the shot, she developed a heaviness in her leg on the left.  She was able to move it, but it felt heavy.   Pt continues to report intermittent heaviness, weakness and paresthesia on L side of face and in L upper and lower extremities x10days
Headache, body aches (mainly legs), extreme fatigue, chills. Started about 3 AM day after shot and lasted about 24 hours. Sore arm lasted 4 days.
Day after vaccine I was extremely tired - it lasted 1 day.  Starting 5 days after vaccine, where I was injected with the vaccine, I had itching at the site and raised red circle about 1.5 inches in diameter around the side.  It is day 9 after being vaccinated and the itching and redness persists.
Vaccines 1/22-evening started fever. Highest 101 deg but eating poorly and without Tylenol fever returns-Dr out of office sent to ER.
Severe knee pain in December 2000, given Vioxx. Wrist pain, hip pain, shoulder pain to date. Per 1 year follow up: Pt did not recover. Osteoarthritis (knees, back, and hip)
mom states pt had t104 w/vomiting @ 10PM on the noc vax given;
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 6-month-old male patient who experienced being inconsolable. The patient received the first dose on 04-May-2010. The patient also received the third dose of HEP-B-VAX (Merck) and the third dose of PENTACEL (Aventis-Pasteur) on 04-May-2010. On 04-May-2010 the patient was administered HEPTAVAX, PENTACEL and PREVNAR 13 and was inconsolable later that evening and all night. On 05-May-2010 the patient remained inconsolable and the patient was being brought back to the clinic due to the event. No treatment was reported. No additional information was available at the time of this report.