chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temporary vision loss; Migraine aura/migraine headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (temporary vision loss) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine headache.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2020, the patient experienced BLINDNESS TRANSIENT (temporary vision loss) (seriousness criterion medically significant), MIGRAINE WITH AURA (Migraine aura/migraine headache) and NAUSEA (nausea). On 30-Mar-2020, BLINDNESS TRANSIENT (temporary vision loss), MIGRAINE WITH AURA (Migraine aura/migraine headache) and NAUSEA (nausea) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
PATIENT COMPLAIN OF FEELING ANXIOUS WITH CHEST DISCOMFORT. PATEINT DENIES SHORTNESS OF BREATH .  RESPIRATIONS 22 HEART RATE 91 O2 SATURATION 98% DENIES CHEST PAIN
5 minutes after the injection (10:50) my tongue felt like it was bigger and my throat felt like someone was slightly choking me. This feeling finally went away at 1:25pm. I did not report this to the EMT standing by as I felt embarrassed.
Diarrhea, Nausea, Sore Arm, Headache and Vomiting.
Initial repot received from a Healthcare professional on 19 August 2013. A 54-year-old female patient has received second intramuscular dose of Rabies vaccine (Manufacturer: unknown Lot number: not reported) in the deltoid on 17 August 2013. The patient had no known allergies or illness at the time of vaccination. The patient's concomitant medications were not reported. The patient had exposure to bat on an unspecified date and had received first dose of post exposure rabies vaccine (may be RABAVERT, but reporter was not sure of the product and did not have lot numbers) series on 14 August 2013, intramuscularly in the deltoid. The patient did not receive rabies immunoglobulin. On 19 August 2013, 2 days after vaccination, the patient had experienced 2 slightly red, raised pruritic, rash areas on each buttock. Laboratory details and corrective medication was not reported. The outcome of the adverse event was unknown. Documents held by sender: none.
The day after the shot, I had pain, soreness and some redness on my upper left arm around the area of the injection. The fifth day my upper arm became very red, itchy and hot to the touch. I had a red patch about 5 inches long and three inches across around the injection site. These symptoms remained intense for about a week and resolved about two weeks after the injection. At that time, I noticed pain in my right shoulder and began having trouble reaching my right arm behind my back. I continued to lose mobility in my right shoulder through late July and also noticed tingling in my right hand. By mid July, about 4 weeks after the injection, I began noticing pain and losing mobility in my left shoulder.   August 18, 2020 - primary care provider prescribed 5-day course of prednisone 40 mg per day; relieves pain somewhat, but pain comes back after 5-day course over; shoulders remain frozen; pain when pushing limits of mobility; tingling remains in right hand
After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EMS responded to the patient the patient went unresponsive slumped over in his chair with seizure like activity. Patient was being moved when he regained consciousness. Patient was moved to EMS area. Patient was pale, lightheaded and nauseous.  Blood pressure was taken as well as oxygen and heart rate. Blood sugar was checked and an IV was started. Patient was stable and transported.
Mild fever 101* Body aches Kidney pain (moderate) Pain when urinating (moderate)  Easily winded
had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm; Administered doses from excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) and EXPIRED PRODUCT ADMINISTERED (Administered doses from excursion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-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 PRODUCT STORAGE ERROR (had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) and EXPIRED PRODUCT ADMINISTERED (Administered doses from excursion). At the time of the report, PRODUCT STORAGE ERROR (had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) and EXPIRED PRODUCT ADMINISTERED (Administered doses from excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Source document received on 25/5/2021 does not contain any new information
Very little soreness in my left arm after the 2nd vaccine as compared to 1st.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 25-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO179) via an unspecified route of administration in the left arm on 01May2021 at 12:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient experienced soreness in left arm. The patient experienced very little soreness in her left arm after the second vaccine as compared to first. The patient was expecting more adverse effects. The clinical outcome of the event soreness in left arm was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe swelling and pain (L) upper arm, improved before Rx approximately 50 percent. Rx: Prednisone.
Pt complains of itchy throat post vaccination.  Itchiness is the same as prior COVID vaccine dose (did not require rescue medication).   BP 125/71, HR 71, RR 18.  Itchiness resolved, patient stable and released from the vaccination site.
I woke up the day following vaccination with chest pain, trouble breathing, a fever, body aches, my left arm so sore I couldn't lift it, and a headache so severe that as a grown man I had bouts of tearing up/crying on my  hands and knees. I thought my brain was swelling up against my skull. I was in so much pain I was afraid but avoided going to a hospital because I cannot afford it. My primary care doctor told me that "everyone in her office" got this sick after getting vaccinated and that I would be fine in 48 hours in all likelihood. On the fifth day after vaccination I still had chest pain, trouble breathing, and fatigue but other symptoms had subsided. I normally run dogs multiple days per week, and do intensive yoga and weightlifting 4-5 days per week. More than 7 days after vaccination I hardly have the energy to do basic tasks and get winded / can feel my pulse in my temples after going up or down a small flight of stairs in my house.
tenderness in underarm (left side); This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history not reported. Concomitant medication included unspecified medication birth control (MANUFACTURER UNKNOWN) on an unknown start date received within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced tenderness in underarm (left side), the patient thought it could possibly be a lymph node. The patient did not receive any treatment for the event.  The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tenderness in underarm (left side) was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Just like COVID-19 - head ache, chills, fever, extreme weakness - seriously, I almost died (this is NOT an exaggeration) - from early Saturday morning until mid Sunday (about two days)
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, start therapy date was not reported, 1 total  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, as per reporter "That is was they want. These people are killing us. Lost my sister in law who was fully vaxed, lost a friend also vaxed, and an uncle who is critical fully vaxed. These people are playing you very badly. I am sorry you live in fear. I am not vaxed had covid it sucked but dr. Prescribed hydroxychlorquin and I took zinc and vitamin d3 felt great in 30 hrs".  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220231819 and 20220232101.; Sender's Comments: V0: 20220231552-covid-19 vaccine ad26.cov2.s-Death. The event(s) has a compatible/suggestive 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Shot made my arm get red, was very sore and had red welts. A lot of pain in arm. Right arm, took aspirin for pain. Arm got swollen from shot to elbow for 4 days.
EE reviewed contraindications and verbalized "non" to all contraindications. Vaccine administrd at 1045. 1100 EE stated "I feel weid". EE complained of SOB and dizziness. RN and LVN assisted EE to floor and elevated lower extremities. EE was taking deep breaths, pulse normal. RN, Called  ED to notify them of EE situation. 1110 EE breathing normal and EE verbalized, " no feeling of dizziness" and was assisted to sit in chair. 1113 RN escorted EE wo security golf cart and was transported to ED by Manager of security. EE was stable.  ED Note 55-year-old male presenting with dizziness and anxiety after vaccination.  This is a potentially seriously ill patient with significant medical complexity and risk who was assessed emergently on arrival given their concerning story.  Differential includes but is not limited to orthostatic hypotension, cardiac dysrhythmia, atypical presentation of myocardial infarction, allergic reaction, adverse effect of medication.  Fortunately, the patient denies any chest pain his troponin is not elevated with no ischemic findings on his EKG.  He is nonfocal neurologically make me doubt stroke.  He has no findings at this time to suggest an anaphylactic reaction and his vital signs are within normal limits.  Orthostats were checked and negative.  He has no anemia, leukocytosis or emergent electrolyte derangements that could be participating in his symptoms.  Patient is tolerating oral intake and asymptomatic at this time.  He was monitored and on serial reassessment developed no no recurrence of symptoms.  He is safe for discharge at this time but ED read precautions were given and the patient was discharged from the emergency department in good condition. Impression: Acute dizziness anxiety, suspect adverse medication reaction
Intussusception 7/26/07-records received for DOS 6/30-7/7/07-DC DX: Intussusception. Exploratory laparotomy and appendectomy on 7/2/07. On 6/30/06- C/O fever, nausea vomiting since night before. Sudden onset of vomiting became projectile. Bloody DiarrheaTemp 100.5.
Pt received vaccination while at clinic for routine monthly lab appointment. Medications & allergies were reviewed, Influenza screening & consent signed and VIS reviewed. Patient has never had reaction to the vaccination. Immunization was on a Friday and patient came into office the following Monday stating several hours after receiving the injection she had developed hives & itching affecting her abdominal region. She stated she took Benadryl 50mg orally and went to bed. The hives were nearly gone the next day and completely gone 2 days later. On the 3rd day after receiving the vaccination (Monday) she woke up with swollen lips. Patient denies food allergies or having come into contact with any products she has never used. Nephrologist was notified the day the reaction was reported and there were no orders given at that time. Patient stated she believes she has an allergy to cigarette smoke and is wondering if the smoke from recent wildfires in surrounding states may have caused the reaction. Patient will follow up with her Primary Care Physician.
Vaccinated with Pfizer COVID vaccine (3rd dose) and influenza vaccine but I do not know the manufacturer/lot.  The vaccination was done in the community I do not know which setting.  15-20 minutes after vaccination she had brief syncopal episode with fall from standing, likely vasovagal syncope and was admitted to the hospital for observation under my care.  No fever, abnormal vital signs or any evidence of an allergic reaction.  She had a scalp hematoma from the fall, otherwise uninjured.
No adverse effect reported.; one patient received an improperly stored V ARlV AX; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-AUG-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R006221, expiration date: 29-FEB-2020 (or lot # R029517, expiration date: 14-OCT-2020)(dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The nurse reported that the varicella virus vaccine live (oka/merck)(VARIVAX) experienced two temperature excursions: one on 12-AUG-2019 and one on 13-AUG-2019. Neither were reported to the nurse until 06-SEP-2019. The nurse did not have the specific lot or expiration administered to the patient but it was one of the two reported. The vaccine underwent temperature excursion of minus 14 Celsius degrees to minus 10 Celsius degrees (-11.91 Celsius degrees, multiple) for 8 hours. There were no previous temperature excursions. The digital data logger was involved in recording excursion details. No adverse effect was reported.
About 10 minutes after vaccination the patient began profusely sweating. He then feel to the floor from the chair during his observation period. 911 was contacted and the patient attended to. Help arrived and they ran a few tests, he was conscious, and gave the clear. After sometime he began to feel better and remained in the store for additional time after the paramedics left. It was recommended he call a ride to drive him home. He spoke with the pharmacy staff said he felt well and was meeting his ride outside and left.
The morning after I received my vaccine I began to have unexpected vaginal bleeding. The Jolessa birth control that I am taking allows me to skip my periods by continuing to take the active pills nonstop and skip the placebo pills, so this bleeding was unexpected, as I do not have a regular period or ?withdrawal bleed? on a regular basis. The bleeding has not stopped and has been consistently a moderate-heavy flow, going on 20 days straight now.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 1/22/21 (lot not listed in Registry) Pfizer Dose 2 2/12/21 (lot not listed in Registry) Pfizer Dose 3 10/4/21 (lot not listed in Registry) COVID Positive 10/20/21  10/20/21: 83 year old male with history of Rheumatoid arthritis, paroxysmal atrial fibrillation on Eliquis and atenolol, restrictive lung disease presents form outpatient clinic with weakness. history obtained from patient and wife at bedside. Notes for the past 3 weeks he has been increasingly weak. in wheelchair at baseline secondary to several knee injuries and subsequent infections. Used to be able to transfer to car/recliner with ease no longer is wife able to help him by herself. Also reports of worsening memory. he is frequently confused about their plans for the day when they just went over their schedule. He was seen in the ED on 10/15 for chest pain and shortness of breath. Cardiac workup was negative including negative CT angiogram which ruled out pulmonary embolism.  He is currently in the middle of a prednisone taper ordered by patient's rheumatologist, has been taking 2 tabs for one month, 1.5 tabs daily this month. Is to take 1 tab daily beginning on November 1. Also concerns about increased urinary frequency and urgency as well as incontinence at night. Patient denies fever, chills, suprapubic pain. UA in emergency room was unremarkable.  Chest pain symptoms are present intermittently mostly in the morning. Feels like a pressure that lasts 10 minutes with some shortness of breath and resolves spontaneously.  He has history of depression for which he takes Buspirone duloxetine, however wife reports decreased mood during this time.  Of note, patient has not been in physical therapy for the past 2 months, which he and his wife feel he had been benefitting from.  11/12/21: Patient was admitted to skilled care for post COVID every decreased weakness and frequent falls.  He underwent PT and OT.  Midodrine was added to his regimen in order to maintain adequate blood pressure.  He has significantly improved in his ability to ambulate after starting this medication.  Additionally there was a concern he was over-sedated on Cymbalta.  This was cut from 60 mg to 30 mg. He has continued to do well and will be discharged to post care at nursing home
Cellulitis at the injection site; Tenderness in the Left Armpit; This spontaneous case was reported by a physical therapist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis at the injection site) and TENDERNESS (Tenderness in the Left Armpit) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced TENDERNESS (Tenderness in the Left Armpit). On 15-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis at the injection site). At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis at the injection site) and TENDERNESS (Tenderness in the Left Armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details was provided.; Sender's Comments: Very limited information regarding this event of cellulitis has been provided at this time.  Further information has been requested
Her eyes still have some burning; syringe came apart at the needle and product got on her face, including her eyes; syringe came apart at the needle and product got on her face, including her eyes; syringe came apart at the needle and product got on her face, including her eyes; syringe came apart at the needle and product got on her face, including her eyes; This spontaneous report was received from an office manager and refers to a 56-year-old female physician. Her concurrent condition included seasonal allergy. Her pertinent medical history and concomitant medications were not reported. She was contact lens user.  On 23-MAY-2019, the physician was administering varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034396, expiration date not reported, but upon internal validation established as 27-NOV-2020) (strength, dose, route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (STERILE DILUENT MRK) (lot # N035975, expiration date not reported, but upon internal validation established as 29-AUG-2020).  On the same date, after the vaccine was reconstituted and drawn into the syringe, the syringe came apart at the needle and product got on the physician's face, including her eyes. The syringe did not come apart at any time during reconstitution or when drawing the vaccine into the syringe. The physician removed her contact lenses and rinsed her eyes with water, however her eyes still have some burning. An unspecified treatment was given for the event. No lab diagnostics were performed. At the time of reporting, the outcome of the event was reported as not recovered.  The relatedness between the event and suspected products was not provided.
Patient reported a few minutes after receiving vaccine that her throat was swelling.  It began on one side of her throat and moved to the other. after a few minutes her voice began to change and it was difficult for her to speak. She had no difficulty breathing. 02 100%, She reported having these symptoms when she is around cats and that it would usually pass after benadryl and fresh air. benadryl was given. patient did not show improvement with benadryl . patient advised for us to call 911. She refused. Advised to go to ED and refused. She was with her husband who said they lived 2 minutes away from the hospital and that he would take her to the ED or call 911 if she got worse.
pt cried x 6 hrs intermittently; was very irritable, t101 ax; over 4 hrs period, temp dropped to 96, remained very irritable; no redness or swelling @ inject site;