chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected adverse reaction following her 2006 FLUMIST vaccine. She remembers no immediate reaction following this intranasal vaccination; however about 24 hours later she noted onset of nasal congestion, runny nose, facial - head pain, and bilateral ear fullness/pressure. She also reported when she bent forward to examine a patient and she lost her balance experiencing a bout of vertigo. She described the sensation as a room spinning with stumbling gait. Her balance stabilized once head up and by holding to nearby counter top. Her dizziness resolved and gait steadied, but she needed to move slowly and was unable to bend over as symptoms returned. She continued to experience loss of balance and dizziness whenever she bent her head and did fall onto floor with stumbling gait trying to regain her balance. She denied any injury from falling and stayed home from work x 24 hours. She and her husband monitored her symptoms and did not seek further medical care. She denied any fever, malaise or myalgia with this episode. She advised it took 72 hours for dizziness to fully resolve and about 5 days for URI like symptoms to resolve. She has had no recurrences as of 2011. Between 2006 and 2010 her influenza prophylaxis was in the form of injectable TIV.
During administration of influenza vaccine to this patient, some of the vaccine leaked and sprayed onto the patient's arm resulting in an incomplete dose being administered.
Signs of miscarriage 8 days after the vaccine. Had my first ultrasound on 4/6/2021, heard the heart bit. Based on doctors recommendation scheduled the COVID vaccine. First doze administered was on 4/15/2021, immediate side effects were sore arm and felt tired only that day. On 4/24/2021 started getting unusual discharge, no bleeding but brown color. Saw my doctor on 4/27/2021, ultrasound showed no heartbeat and that the baby stopped growing after the first appointment. There was no development after the 8th week.
Recieved the flu vaccine on 09/03/14 and then noticed rash to chest and upper abdomen upon awakening on 09/05/14. Also reports "achiness" to upper chest and upper back area. Relates feels like she was running a fever but was noted afebrile.
Headache started on April 12, 2021 about 5-6 hours after injection. Fever and body aches came later that night. Fever, body aches, headache continued all night and the entire day of April 13. Symptoms cleared on April 14.
Within 90 min. of injection:severe hot flashes, extreme perspiration and constriction of chest. A large bruise/discoloration appeared at injection area that has not faded 10 days later. Some neck stiffness also noted. Hot flash lasted about an hour, chest constriction lasted 3 days off and on.
Feels "heart is pounding" and right sided chest pain. Director consulted and patient observed for 30minutes with no distress, Vital signs stable, and advised to have EKG at PCP or Urgent Care Center in abundance of caution.  Dr. cleared patient to leave without EMS consultation.
Fully vaccinated with COVID breakthrough infection.   Asymptomatic COVID + while hospitalized for non COVID reason.
woke up 3 days after receiving first COVID injection and tried to stand up and fell back on bed; woke up 3 days after receiving first COVID injection and tried to stand up and fell back on bed; connective tissue in both knees was excruciatingly painful; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 15:00 at the age of 44-year-old as single dose for covid-19 immunisation. Medical history included lymphoedema. No known allergies. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient woke up 3 days (28Mar2021 07:00) after receiving first COVID injection and tried to stand up and fell back on bed. The connective tissue in both knees was excruciatingly painful. Hurts the worst when he wake up and it got better as he was up on it. The events resulted in disability or permanent damage. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. The patient received second dose of bnt162b2 (Lot Number: ER8733) on 21Apr2021 16:00 in left arm.
Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 10:00 as dose 2, single (Lot number: EN6202) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Penicillin, reaction(s): "Allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EL9269, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 09Feb2021, when the patient was 56-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 04Mar2021, outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Reported Event: Patient reported Tinitus in her left ear that had not gone away. It was so bad it deterred her from receiving a booster for fear of it becoming worse or even worse than that, in both ears. A CONSTANT ringing and chirping in her ear. She had tried different things to help cope with the nagging, sometimes debilitating irritation of the noise in her head (ear). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.
2 days p/vax pt exp urticaria on forehead, abd, & rt leg
lips swelling; The tissue around the mouth and chin was swollen; A spontaneous report was received from a consumer (patient's caregiver) concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lips swelling and the tissue around the mouth and chin was swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in right arm  for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the event(s) lips swelling and the tissue around the mouth and chin was swollen.  Treatment details included antihistamine.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), lips swelling and the tissue around the mouth and chin was swollen was recovered.
My right arm became swollen within 5 minutes of the shot. It started in my finger tips and went up my forearm and elbow. I experienced tingling in my fingers and a sharp pain in my elbow. My breathing remained normal. I received Benadryl at the testing site. I was advised to continue to take it every 4 hours to alleviate the swelling. It took three two pill doses of Benadryl and icing my arm for the swelling to go down. There is lingering pain in my elbow and wrist.
Concern for Vaccine induced Myocarditis. Fever 101, headache,  started 12 hours after vaccine dose #2. 48 hours after vaccine,  severe substernal chest pain with left arm radiation, fatigue required emergency visit to ER to rule out Myocarditis. Patient is currently being watched for myocarditis development in this young male.
her 29 y/o son has Aspergers and received his 2nd Pfizer vaccine dose 9 days ago.; fatigue; pressure behind the ayes/pressure behind his eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asperger's" (unspecified if ongoing), notes: Patient history: Asperger's; "congenital myopathy" (unspecified if ongoing), notes: Caller states her son was diagnosed with a "congenital myopathy a few years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "her 29 y/o son has Aspergers and received his 2nd Pfizer vaccine dose 9 days ago."; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "pressure behind the ayes/pressure behind his eyes"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
nauseous, faint, chills, body aches, diaphoretic, hypotensive, tachycardic - 2 hrs after vaccine given epi 0.3mg given with good response
BLOOD CLOTS; STROKES; BRAIN BLEED; SEVERE RESPIRATORY PNEUMONIA; This spontaneous report received from a consumer via a company representative through social media concerned a 53 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported, 1 total was administered for prophylactic vaccination.  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 blood clots, strokes (transient ischemic attack) affecting her circulation to face and brain. Patient had lots of blood thinners and later she was able to work until she had brain bleed and severe respiratory pneumonia and she was hospitalized (date unspecified). Again she had more strokes and currently her memory and speech was affected and she has to go on disability.  It was reported that "Your Covid-19 shot disabled my sister permanently blood clots giving her TIA strokes affecting her circulation to her face and brain. Lots of blood thinners later she was able to work until a brain bleed and severe respiratory pneumonia forced her to be hospitalized again where she had more strokes. Now her memory and speech are affected she has to go on disability. She was a healthy 53 year old and j and j cannot be sued." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, strokes, brain bleed and severe respiratory pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220554056-covid-19 vaccine ad26.cov2.s - blood clots, strokes, brain bleed and severe respiratory pneumonia. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Patient has not yet reported any adverse event. Error was realized after administration and patient has already left the facility. No treatment administered.
Left arm hurts; Her inflammation is horrendous today on ankle and hands; A lot of twinge in on the left side between your arm area and near the heart; Her inflammation is horrendous today on ankle and hands; This is a spontaneous report from a contactable consumer, Pfizer colleague. A 60-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 in the arm on 04Oct2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and known allergies were reported as unknown. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received other vaccines within four weeks prior to the vaccination. It was unknown whether the patient received any concomitant medication. On 05Oct2021, her left arm hurts and a lot of twinges in on the left side between her arm area and near the heart. Her inflammation was horrendous today (at the time of this report) on ankle and hands. She had dose one injected on 04Oct2021 and the reporter received a text from her today. The events did not result in doctor or other healthcare professional office/clinic visit, 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 left arm hurts, a lot of twinges in on the left side between her arm area and near the heart and her inflammation was horrendous today on ankle and hands was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
LEFT LEG BECAME SWOLLEN AND RED, ITCH, BLOTCHY VERY UNCOMFORTABLE
Complaint of a new onset migrane on the pt's left side which began on 4/17/21 - 3 days after the 2nd dose was administered. Pt never experienced lasting migranes prior and symptom is continuing thru today 4/28/21. Complaint that the migrane feels externally painful and sensitive to touch.
Patient received FLUMIST for H1N1 and did not know she was pregnant at the time.  12/7/09 Medical records received for date 11/30/09. DX: pregnancy. Pt states pregnant and unsure of dates. Assessment: no fetal heart tone heard. Will order US.
p/vax pt had very poor pallor;dusky appearance;eyes fixed/starring;very minimal weak cry;respirations inc, tachycardia;mom & pt kept in office for over 30min for cont observation;pallor returned;hypotensive episode;slept extended period;
Feels like weeping under patch; Itchy looks like sun burn; The skin at application is red; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WEEPING (Feels like weeping under patch), VACCINATION SITE PRURITUS (Itchy looks like sun burn) and VACCINATION SITE ERYTHEMA (The skin at application is red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN WEEPING (Feels like weeping under patch), VACCINATION SITE PRURITUS (Itchy looks like sun burn) and VACCINATION SITE ERYTHEMA (The skin at application is red). At the time of the report, SKIN WEEPING (Feels like weeping under patch), VACCINATION SITE PRURITUS (Itchy looks like sun burn) and VACCINATION SITE ERYTHEMA (The skin at application is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included "Rhodes Bup", and pain patch.  Per report, the patient used a pain patch without complaints prior to receiving his vaccination and the subsequent skin reactions.  Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant FU - Patient Initials was updated.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information about patients' concurrent condition, medical history and concomitant medication. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M005733, expiration date 01-OCT-2017, lot # M006111, expiration date 18-NOV-2017, lot # M016238, expiration date 07-DEC-2017, dose not reported) orally for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Telephone attempt on 07-DEC-2016 to obtain follow up information had been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA008911: US-009507513-1610USA009514: US-009507513-1610USA009512: US-009507513-1610USA009513: MERCK 1610USA009515:Mfr number.
the patient did not get the full dose; Fluzone Quadrivalent prefilled syringe that leaked from where the needle attaches; some of the vaccine ran down the patient's arm; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 24 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that the patient did not get the full dose (underdose), Fluzone Quadrivalent prefilled syringe that leaked from where the needle attaches (syringe issue)and some of the vaccine ran down the patient's arm (exposure via skin contact).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6681LA via unknown route in unknown administration site.  It was a case of actual medication error due to vaccine underdose.  It was also a case of syringe issue and exposure via skin contact.  It was unknown if the patient had any adverse event.  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.  List of documents held by sender: none.
No adverse action, but error on medical assistant, given MMR/V in addition to MMR.
10 days following the first J&J vaccine, I experienced sudden onset chest pain and shortness of breath in addition to lightheadedness, faintness, and rapid heartbeat. The chest pain was relieved by aspirin 325 mg, however the pain would return once the aspirin wore off. I went to Hospital less than 48 hours later, where they performed a work up to rule out a pulmonary embolism. They ultimately sent me home with a broad diagnosis of heartburn and told me to follow up with my primary care provider "as needed." After reviewing the documentation in the Hospital notes, they failed to document that I had received the J&J vaccine 10 days prior to symptom onset and that my mother has a history of blood clots. Knowing that I did not have heartburn, I scheduled an appointment with a cardiologist who diagnosed me with pericarditis. I am currently being treated with high dose aspiring (325 mg TID) and colchicine 0.6 mg daily, no exercise/caffeine/alcohol for 1 month. Symptoms have started to improved after 1 week of treatment. Follow up with the cardiologist in another 3 weeks.
Covid19 Bivalent vaccine lot #GP4345 had a 10 week expiry of 04/07/2023. Administered vaccine seven days past the BUD on 0/14/2023. We contact Pfizer on 04/18/2023 for Stabilit assessment: Stability dad DOES NOT SUPPORT for our excursion. We will re-vaccinate patient.
Red; Swollen face; Palpitation; Dizziness; Injection iste hard; Allergic reaction on her legs; injection site is inflamed; Injection site painfull; headaches; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness) and VACCINATION SITE INDURATION (Injection iste hard) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Heart murmur, Skin cancer and Brain cancer metastatic (Brenign brain cancer). Concurrent medical conditions included Depression. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, ERYTHEMA (Red), SWELLING FACE (Swollen face), PALPITATIONS (Palpitation), DIZZINESS (Dizziness), VACCINATION SITE INDURATION (Injection iste hard), HYPERSENSITIVITY (Allergic reaction on her legs), VACCINATION SITE INFLAMMATION (injection site is inflamed), VACCINATION SITE PAIN (Injection site painfull), HEADACHE (headaches), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
Mom reported fever of 102.3 rectal (uncorrected) 30 hours after recieving Pediarix (left leg IM),Prevnar 13 (left leg IM), HIB (right leg IM), and Rotarix (right leg IM). No other symptoms, fever resolved with Tylenol.
Patient reported typical arm soreness he has experienced in the past from annual influenza injection.  The soreness never completely resolved and now he has nerve pain in the shoulder that radiates from the front of the shoulder to in an arc to the rear of the shoulder. His chiropractor recommended that he document the injury with the pharmacy where he received his annual influenza immunization.  When he reported his experience to me on 12/28/19, I recommended that he have his arm examined by his primary medical provider (MD).