chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 24Apr2022, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were not taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt reports that 13 days after vaccination, he noted a large red, raised area at the injection site measuring 8" long by 5" wide. He notes that area is warm to the touch and pruritic, but not painful. Pt states that he sought treatment at the Emergency Department, where he was prescribed antibiotics. He notes improvement with treatment, states the redness is beginning to resolve.
Patient was given a vaccine with an expired beyond use date. The vaccines beyond use date was 6/28/2022. I called Pfizer - Case #00703287/Reference #COKY36S4. I had to fill out paperwork about storage and temperatures and submit temp logs and min/max temps, along with calibration certifications. I received documentation back that "Currently available stability data demonstrates the vaccine maintains quality through 73 days of storage at 2 degrees Fahrenheit and 8 degrees Fahrenheit. I gave the vaccine on day 73 first vaccine given out of the vial. Vaccine as given, approved by manager.  Was advised to submit a VAERS, even though the vaccine was determined to be good. No further action.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
11/6/21 Pt admitted to hosp as a transfer from another hospital for critical care management; was diagnosed positive for COVID on 11/1/21; pt in hypoxic respiratory failure and septic shock due to COVID pneumonia; given Baricitinib and dexamethasone; ABX; vasopressors and sedation; Right IJ vein DVT, on heparin drip; pt's condition quickly worsened; DNR; he passed away in the hospital.
PATIENT RECEIVED VACCINE AT APPROXIMATELY 11 AM ON 1/11/08 AND CALLED COMPLAINING OF "THROAT CLOSING UP". PATIENT WAS ADVISED TO GO TO THE ER IMMEDIATELY (TO BE DRIVEN BY SOMEONE). SHE TOOK BENADRYL BEFORE LEAVING HER HOME AND ENDED UP LEAVING THE ER AFTER MORE THAN AN HOUR WITHOUT BEING SEEN BECAUSE OF THE LONG WAIT. AT THAT POINT SHE WAS FEELING MUCH BETTER. NO HX OF ADVERSE DRUG OR VACCINE REACTIONS. FIRST DOSE OF GARDASIL. NO COMPLAINTS FOLLOWING EVENT. NO HX OF ASTHMA OR OTHER MEDICAL CONDITIONS.
Pt passed out for 30 seconds after receiving her vaccines.   Cold compresses applied to pt?s head and neck. Pt drank some water.  BP 100/63 P: 78 Temp: 96.8 99% on room air.  Pt was monitored for 15 mins and then sent home
5 yo female presents to the clinic accompanied by her mother for an infection on her left leg, the MOP states that the pt has gotten shots done and got one on her left leg, the Mop states that there has been a warm spot that has arose on her leg and she states that it has gotten worse since then, the mop states that it had arise over the weekend, the pt reported there has been tenderness in there area with low grade fever which lasted 2-3 days.
Patient returned to clinics day after immunization complaining of vomiting and throat feeling tight.  Injection site was warm to touch and very red.  Temp-97.3, BP 110/64, pulse 87.  Arm remained aggrevated for 6 days and patient complained for being tired and weak during this timeframe.
Sore Arm, Fever, Body aches, Headache. Lasted 24hrs
Patient was brought to office by mom, She states that on Friday patient woke up and had a rash on her arm and Neck. Mom states that the rash has worsen and it itches and is hot to the touch. As off today 05/27/2020 mom states that her rash on her neck has mostly gone away but seems to be coming back. On the back of the right lower arm  patient has a welt about a nickle size, which is red and hot to the touch and has a yellow Bloch in the middle were Proquad was administered. Patient was evaluated by Provider and was given a dose of Benadryl in office and  mom was advised to watch patient and continue with Benadryl and go into UC if worsen.
I cannot say that the symptoms I am experiencing are due to the COVID vaccine but I have never had these chronic problems before.  I first noticed gut discomfort May 8, 2021, that?s a few days after I am considered fully vaccinated.  Also, symptom wise, lethargy and weird back pains.  These symptoms have plagued me ever since then.
Patient received flu vaccine at school flu clinic. A few hours after, he developed a diffuse red rash on face and trunk of body. MD reported vesicular in places. He also developed a low grade temp of 100 degrees F.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no information about concurrent condition, concomitant medication and medical history. On 16-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L025000, expiration date 06-OCT-2016) (dose and unit unknown) subcutaneously. No adverse effects were reported. Additional information has been requested.
I received my first vaccine of the Pfizer lot EL1284 on 12/28/20 and my second dose of lot EL3249 on 1/19/21.  On March 13th, 2021, after 25 years of clock-work menstrual cycles, I woke up having not only started my period early, but I bled through my clothes and into the bed- something that had never happened to me.  Since March of 2021, this has occurred at least 3 other times (the heavy bleeding into my bed).  I have also yet to have a regularly timed period (prior to my vaccines I started between day 27-28).  My periods now range anywhere from 20- 32 days.  They also vary in how long they last and how heavy the flow.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. 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 not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected Covid-19 infection and suspected clinical vaccination failure. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193347; Sender's Comments: V0:20210926597-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Headache, chills, fatigue, extreme runny nose, swelling and soreness at injection site. Ibuprofen , sudafed lots of fluids, sleep. Chills and headache broke about 28 hours after onset. Runny nose responded to ibuprofen immediately. Injection site is still sore.
Patient presented with an injection site reaction. It was red around the area and warm to the touch. I recommended for patient to ice the area and take BENADRYL as needed for the itch.
received Prevnar 13 8/2/2021, next day broke out in rash/hives. referred to CT Asthma and Allergy for evaluation to Prevnar component of that vaccine vs coincidental hives/other etiology of hives.
3rd HPV vaccine on Thursday 9/23/2021. Injection site was itchy; pt felt dizzy, sweaty, lightheaded, anxious, rash on cheecks,  and headache and abdominal symptoms and a rash on upper chest wall ("flushing and inverse hives" as she calls it).  Pt spoke to a triage nurse over the weekend and was told to use benedryl & zyrtec.  She was eventually seen in walk in care on 9/27/2021 for continued symptoms including some wheezing. She was told to use her epi pen and symptoms improved while she was there.  Symptoms recurred on 9/28/21 so she was seen in the urgent care: included a posterior headache, lightheadedness, abdominal distension, nausea, chest tightness and a rash involving her throat and upper chest. She took another EpiPen around 8:10 PM and presents to the ED for evaluation and discharged with a repeat dose of Decadron to take in a couple days if symptoms persisted.  She has continued to have symptoms come and go generally as the zyrtec and steroids are wearing off in the afternoons: rash, fatigue, headaches.
Client was given an expired dose of vaccine. Monitored client for 15 minutes and no adverse reactions were noted. Called client the day after and he reported no adverse reactions.
Developed a ringing in both ears in early hours of Mar 3rd. Virtual doc on Mar 6th. He prescribed 7 day amox/k clav 875-125 tab and ipratropium bromide nasal solution 0.06%. After the meds the ringing persists especially at night.
Allergic reaction to vaccine +1 more Dx Referred by MD Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Physician Assistant Cosign Needed      Patient was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.  She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer-Biontech (lot:  EH9899) vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience oral tingling (upper lip and then into the lower lib)  It then progressed to the tongue and she reported tingling to the tip of the tongue and further back to the middle of tongue.  She thought there might be some mild swelling to the tip of the tongue.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling and lip swelling.   This Staff member was notified of patient reaction and she was then assessed in the emergency bay area.   PMH:  Hx hypertension but did not take her medication today.  Patient had recovered from the COVID-19 virus about 2 weeks ago.   Vitals Time 1130 BP 170/90 HR 86 s/r RR 14 nl O2 97 %   Physical Exam  Constitutional: She is oriented to person, place, and time. She appears well-developed and well-nourished. No distress.  HENT:  Head: Normocephalic and atraumatic.  Right Ear: Hearing and external ear normal.  Left Ear: Hearing and external ear normal.  Eyes: Conjunctivae are normal. Right eye exhibits no discharge. Left eye exhibits no discharge. No scleral icterus.  Neck: Normal range of motion.  Cardiovascular: Normal rate, regular rhythm and normal heart sounds.  Pulmonary/Chest: Effort normal and breath sounds normal. No stridor. No respiratory distress. She has no wheezes. She has no rales.  Musculoskeletal: Normal range of motion.  Neurological: She is alert and oriented to person, place, and time. No sensory deficit. Gait normal.  Skin: Skin is warm and dry. She is not diaphoretic.  Psychiatric: She has a normal mood and affect. Her behavior is normal. Judgment and thought content normal. Cognition and memory are normal.  Vitals reviewed.     Treatment included antihistamines.  Patient was given 50 mg of benadryl at 1138.   Vitals Time 1147 BP 160/100 HR 90 S/R RR 14 nl O2 98%   Response to care:  Patient states the upper lip resolved but the lower lip and tongue sensations remained but did not worsen.  Patient was recommended to go to the hospital given her sudden response with concern of tongue swelling.  Patient did agree to this.  COVID staff was made aware that the patient would be leaving her SUV in the parking lot.   Patient was transfer by Response team to the hospital at 11:53 AM.
Fever 103 x 6 hrs. Back, neck and leg pain, dizziness.
10 minutes after receiving vaccine, employee complained of itching to left arm at injection site. Her left arm was red from the itching from her shoulder to elbow.  She also complained that she felt some numbness going down her arm.  She denied any shortness of breath and had no other symptoms.  Upon arrival to ER, she became faint and complained that the numbness down her arm was getting worse.
patient came in for a pneumonia vaccine our immunization selection tool recommended pneumovax 23 but patient got Prevnar 13
Nausea/vomiting, lightheaded, chills and fever, headache. Supportive care: increased fluids and Tylenol. Bedrest x 24 hrs.
Chills and itchy rash at injection site the day after administration (resolved within 24 hours). Reports that after vaccination, started getting itchy splotches across entire upper body that disappear with application of Cetaphil then reappear as 2-3 blotches at a time. Also started experiencing bad pain in opposite (left) shoulder since vaccination.
Headache, Myalgia, Arthralgia, UrticariaPruritus, Diarrhea, NauseaVomiting, chills, fatigue Narrative:  1/13/2021 second dose Chills Headache Joint, Muscle, Body pain Fatigue Nausea & vomiting Diarrhea Moderate itching relieved with diphenhydramine
JANSSEN COVID-19 EUA: fully vaccinated patient presented on 071521 with a 5-day history of headache, congestion, wheezing, fever, cough and scratchy throat. The patient reported an exposure to COVDI-19 on 070821 in both a coworker and a neighbor.
Pt began having seizure at 1831. Assisted to floor in side lying position. Airway maintained. Decerebrate posturing noted. Unable to obtain VS due to tightness of limbs. Pt having cont seizures at 1841 decision to activate EMS with permission. Slight dusky. Patient continues to have seizures. 1854 EMS arrived on scene. Airway maintained but slightly dusky fingers an circumoral cyanosis noted. Transported to hospital.
SHINGLES; RUNNY NOSE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced shingles, and runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shingles and runny nose was not reported. This report was non-serious.
Fuzzy headed confusion day after vaccine, fuzzy headed two days after vaccine, headaches, joint pain,
[Not sure if this is related to vaccine - reporting in case it?s related] DVT in R calf
Nausea, followed by loss of vision, followed by flushing, followed by fainting/loss of consciousness, followed by roughly 20 minutes of disorientation, then mild weakness.
Client received the 1st COVID vaccine Moderna Lot #007C21A expiration date 10/12/2021. Client  reported cold sweat, nausea, and slight headache to our  Medic and requested for a blood pressure check. Client  was sitting in chair and also stated to Medic  "I participate in intermittent fasting, last time I ate was yesterday. I felt dizzy 8 minutes into my 15 minute waiting period." Medical history includes history of anxiety and bipolar disorder, currently takes medication lamictal. Interventions done for client  include laying down in gravity chair and vital signs were taken at 12:03 PM: BP 158/96; pulse 78, respirations 18. Orthostatic vital signs were taken at 12:08 PM BP 162/100; pulse 78. Client was alert and oriented x4 during whole interaction with Medic . Client refused 911 call. At 12:16 PM client  verbalized symptoms resolved and nurse  recommended for stable vitals before being able to leave facility. Final vital signs were taken at 12:25 PM: BP 148/82; pulse 76; oxygen saturation of 99%. Client  left facility walking safely with steady gait at 12:30 PM.
Information has been received from a male patient of unknown age concerning himself. On an unknown date the patient was vaccinated with a dose of MMR II (dose, frequency, route and lot# not reported). On an unknown date the patient experienced very high fever for nearly a week. The outcome of the event was not reported. The causality was not provided. Additional information has been requested.
Patient stated arm was really sore for a couple of days, and then started to get better, but after a few days started to hurt worse again. Vaccine given approximately 2 weeks ago, patient states it started hurting more recently. Stated no tenderness & no issues with shoulder, but that the muscle is sore.  Advised patient have it checked by his PCP. Unknown what he will do.
some vaccine left in the vial and that he hadn't received all of it/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 01-Sep-2021 from a Physician via Agency (Reference number- 00750478) and transmitted to Sanofi on 01-Sep-2021.  This case involves a one-year-old male patient who reported some vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] left in the vial and that he hadn't received all of it with no reported adverse event (Underdose).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications VARICELLA ZOSTER VACCINE LIVE (OKA) (VARICELLA BIKEN) for prophylactic vaccination, MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination and PNEUMOCOCCAL VACCINE (PNEUMOCIN [PNEUMOCOCCAL VACCINE]) for prophylactic vaccination.  On 13-Aug-2021, the patient received a 0.5 ml (total) [1X(Once)] dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ464AB and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was reported, "That her son received a PENTACEL vaccination on 13AUG2021 and was contacted 13 days later and informed that the vaccine was expired. Caller states that she called back to confirm that product was expired and that she was told that the product was not expired. At this time, she was told that there was still some vaccine left in the vial and that he hadn't received all of it but that the product was not expired. Caller states that she has the lot number and would like to determine the expiration date. Caller also asked about the need to revaccinate her son if the product was expired or if he did not receive all of it. "  It was case of an actual medication error due to vaccine underdose (latency was on the same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine.; Tunnel vision; Extreme sense of coldness; Face planted to the floor.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer(patient) reported for himself thata 41-years-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, Batch/Lot number: 59267-1000-01), via an unspecified route of administration, administered in Arm Right on 25Jun2021 18:00 (Age at vaccination 41 years) as single dose for COVID-19 immunisation. Medical history included hiatus hernia and diverticulitis. Concomitant medication(s) included paracetamol (TYLENOL). Patient had no known allergies. On 25Jun2021 18:00, the patient experienced atrial fibrillation was detected but not sure yet if it was an underlying condition or caused by vaccine; tunnel vision; extreme sense of coldness and face planted to the floor. Patient was received treatment for events. It was reported that after patient received shot and exited the medical room, he had extreme sense of coldness come over me, tunnel vision, then face planted to the floor. Ambulance was called, patient regained consciousness about a minute or so later, and my chin was split open. They took me to ER, stapled my chin, and ran tests. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Other medications the patient received within 2 weeks of vaccination include Tylenol. Patient received Cardizem 1/day till doc follow-up visit. The clinical outcome of all events were unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL (strength, dose and lot # were not reported). No adverse effects reported. Additional information has been requested.
Patient states after the vaccine, she developed wheezing, shortness of breath, headache, cough, and hot flashes.  She states her chest feels tight, but denies any irritation or swelling in her throat.
Started with back pain and right leg pain.   Moved to right knee pain and unable to straighten knee.  Resolve and moved to left.  Still unable to fully straighten left knee, left leg weak,  and collapses under me  without warning intermittently.  Treated w/ physical therapy 6 visits produced increased symptom severity.   Now on Prednisone with little relief.
Breakthrough case admission/patient expired after 2 vaccines MOderna 2/16/21 lot# 015M20A ; Modern a3/15/21 lot# 002A21