chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had no adverse at the time, eight days later woke up early am in classic Afib, high heart rate. I went to the emergency room, we were traveling at the time. At home I went to my cardiologist they cardioverted me back, i have been fine since.
w/in 1hr of vax pt devel erythema & induration @ the site of vax;
Within 15 minutes of receiving injection, developed severe fatigue and brain fog as well as very strong stomach ache. Fatigue and brain fog never lifted but progressively got worse.  Digestion became much worse.  Chronic UTI?s began March 2017 and developed interstitial cystitis by fall 2017.  By 2018 the neurological fatigue was severe and insomnia became unbearable.  Had an accident resulting in bulging discs that never healed because neurological system was so fatigued and burdened. Severe systemic inflammation did not allow healing. Was placed on disability Nov 2018, was on it for one full year. Have not worked full time since.
pt recvd vax; 5cm enduration & erythema around inject site that occured w/in 36 hrs;
I woke up on 12/10, packing I had fatigue and sore throat. I started feeling worn out but didn't think much about it. Stating having stiff neck kind of like the flu so I tested at home for COVID-19 and within six seconds and, I was positive. Later that day I went to a clinic to get a PCR and I was positive and that night I stared having a fever. Sunday, I didn't have a fever and then that night my temp sated going up again. I didn't have any of the other things that most people have, it was mild.
17OCT91 began vomiting, facail flush, low-grade fever 100,; 18OCT91 generalized rash over entire body, vomiting ceased, keeping clar fluids down, very itchy; recommended calamine, report to MD, corn starch bath via;
Syncopal episode. Recovered at site. Patient states history of passing out with vaccines in past.
I was trying to do water aerobics as usual (3x a week for over a year), and my heart started pounding when it never did that before. I took it easy for the rest of the workout and was careful to monitor my heartrate during workouts over the next few months.
Central venous sinus thrombosis; This is a Spontaneous case report from a contactable nurse reporting for himself/herself, received from Pfizer Sponsored Program. A 20-years-old patient of an unspecified gender received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, via intramuscular route on 14May2021, at 20 years of age, (Batch/Lot Number: EW0167) as single dose for COVID-19 immunization. The patient had no relevant medical history, except for diagnosis of COVID-19 on an unknown date prior to vaccination and didn't receive any concomitant medication. It is unknown if the patient has been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. On 20May2021 the patient experienced "central" venous sinus thrombosis which resulted in Emergency room/department or urgent care and required the patient's hospitalization. The patient was hospitalized for 4 days. The patient underwent neuro imaging on an unknown date and was treated with enoxaparin (LOVENOX). At the time of the report the event was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Cerebral venous sinus thrombosis due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and angiogram, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
It was reported in an internet article, concerning a female who was vaccinated with GARDASIL vaccine (date, dose, route not reported). The author of the article reported that "one girl on the site above went to the hospital 3 times for the reaction she was suffering before they finally admitted that this was a GARDASIL vaccine reaction. This is one of several reports from the same source. No further information is available.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated orally with improperly stored doses of oral, ROTATEQ (dose, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Rash beginning near injection site and spreading up ipsilateral side vaccine administer 2/6/14; rash began 2/7/14.
patient had an expired Daptacel/ no side effects; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a female patient who received expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received a ActHIB and ProQuad on 29-Apr-2019.   On 29-Apr-2019, the patient received a single 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5190AA via intramuscular route in the right thigh (Expiration Date: 24-Apr-2019).  It was of actual medication error due to expired vaccine used.  It was reported that no side effect was observed.  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.
Pt states after receiving vaccine, she is unable to lift her arm up, area is painful to the touch and she does not have any fever.
started feeling ill 2-3 wk p/vax;exp h/a,fever,pale,chills,fatigue,red eyes,sudden onset of ecchymotic areas on legs,dx w/wegener's granulomatosis mid JAN;recv chemotherapy,kidney dialysis,gravely ill
Pt to observation after receiving vaccine. Immediately upon entering observation, pt complained of dizziness and feeling as though he was going to pass out. RN to vehicle to assess per request of observation staff. Once RN approached car and began to speak with pt, she noted pt to be very pale, diaphoretic and speaking sluggishly. RN laid pt drivers seat all the way back and elevated his feet, pt wife who also received vaccine was in the passenger seat. After pt laid back his eyes rolled back and he became unresponsive. Medics and MD called to evaluate. After sternal rub pt noted to have eyes open and pupils dilated, still unresponsive. Within the minute the medics arrived and pt began to regain consciousness. Pt states he has had this happen before when he has had blood drawn. After medical evaluation from paramedics and the MD, it was recommended pt be further evaluated at hospital. Pt transported to hospital, wife drove personal vehicle in stable condition.
12/8/03 Recieved Td 12/5/03, client states arm has been aching, warm to touch and swollen since night of 12/5/03.  States using comfort measures without relief.  Encourage to see PMD and RTC in 2-3 days.  12/11/03 attempted PC to client, phone disconnected, 12/11/03 MD called pt, did not come to office
pt recv vax 25APR96 & 11MAY96 pt exp a gen rash;
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
Signs of cellulitis at the injection site; This spontaneous report has received from an officer manager through a company representative, regarding to a 72-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 24-SEP-2019, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S013490, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date not reported, but upon internal validation established as 06-MAR-2021 (strength, dose, route of administration and anatomical location of vaccine were not provided) for vaccination.   On 26-SEP-2019, the patient returned to the facility with signs of cellulitis at the injection site (Injection site cellulitis); however, she sought for medical atention and an unspecified physician placed the patient on antibiotic (unspecified treatment). At the reporting time, the outcome of injection site cellulitis was unknown.  The causality assessment between the injection site cellulitis and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Breakthrough case admission after three vaccines Pfizer 2/1/21 Lot# EL9265;  Pfizer 2/22/21 Lot# EM9810;  Pfizer 9/30/21 Lot# 30125BA
pt vaccinated with J&J vaccine in april.  Admitted to hospital on 8/6 with symptoms of nausea, vomiting, diarrhea, loss sense of taste & smell,  and SOB since 8/3.    Patient's COVID PCR was positive on 8/6.  Reporting a breakthrough covid vaccine case.
The Moderna vaccine (6 months to 4 years) primary seires was administered for less than 3 years old kid, but no adverse reaction happened
A report had been received from a Health Professional concerning a 2 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient had administered Expired drug which started on 08-JAN-2015. The outcome of event of administered expired FLUMIST Quadrivalent was unknown. The report was considered to be non-serious.
The red swollen arm 10 days later; The red swollen arm 10 days later; Injection site swollen and red; Injection site swollen and red; This is a spontaneous report from a contactable consumer reported for his wife. A 60-year-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported) via an unspecified route of administration, on 05Mar2021 (age at the time of vaccination was 60-year-old) as DOSE 1, SINGLE for COVID-19 immunization at public health. Medical history was reported as none. The patient concomitant medications were not reported. The patient got vaccine from Pfizer 10 days ago and everything seemed fine but on16Mar2021, where the vaccine site was, it was swelling and redness. The caller wants to know whether the patient can take a Benadryl. The caller wanted to know if that resolves and is it ok to receive second dose on 26Mar2021. The caller stated about the other medical conditions was the red swollen arm 10 days later. The clinical outcome of all the events was unknown.  Follow-up attempts are completed. No further The red swollen arm 10 days later information is expected.
I found out that I have covid/Tested positive for Covid 19; I found out that I have covid/Tested positive for Covid 19; my anxiety's pretty high about it; I haven't been feeling well; This is a spontaneous report from two contactable consumers (one is patient) via medical information team. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EP6955), via an unspecified route of administration in right arm on 23Mar2021 08:20 as single dose for allergies. Medical history included ongoing asthma diagnosed 30 years ago, ongoing obese and ongoing allergies which he always had for as long as patient can remember especially during this time of year. Family history included Asthma and Diabetes on both side of family. Concomitant medications included ongoing montelukast sodium (SINGULAIR) at 10 mg daily) for allergies (has been taking forever; for a long time), and fexofenadine hydrochloride (ALLEGRA ALLERGY) at 10 mg daily for allergies. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). Patient got the firs dose of the Pfizer BioNTech covid vaccine on 23Mar2021 and am scheduled to get the second dose on 13Apr2021. He was not feeling well and went to the ER this morning. He found out that he had covid and anxiety was pretty high about it. Patient wasn't feeling well which started on Easter 04Apr2021. He took a test today and found out he has Covid 19. He had his first dose on 23Mar2021 of the Covid Vaccine. He is scheduled to get his second on 13Apr2021. He has to be in quarantine for 10 days so how would that work. On 06Apr2021 he lost his sense of taste. Then on 07Apr2021 he picked up a candle held it to his nose and could not smell it. He presented to the emergency room on 08Apr2021 (today as reported) where they tested him for Covid 19 and it was positive. Tested positive for Covid 19 after first dose of Covid Vaccine. Chest x-ray at the emergency room was done and it was good; also states his lungs were clear. He was not admitted into the hospital. States that at first he thought his symptoms were due to the time of year, change of weather, and allergies. Says he was alarmed that his symptoms would be like that when he has been taking his medication religiously. This prompted him to go and get tested for Covid 19. Visit to emergency room was required for events not feeling well, loss of taste, loss of smell. The outcome of events not feeling well, Lost sense of taste, Lost sense of smell was not recovered; for event anxiety was unknown.  No follow-up attempts are possible. No further information is expected.
Local Reaction to injection site LD 07/28/04. Left arm swollen, red, tender left deltoid.  Where DTaP was given 7/26- No systemic symptoms. No fever, no chills, no breathing difficult, large area of redness, swelling and some degree induration which is covering most of the deltoid and upper arm and extending to medial aspect of left arm as well. Dx Augmentin 250/5ml 1 teaspoon or if systemic symptoms occur on 7/30/04. Child arm less swollen still red doing ok.
pt recv vax 21SEP98 & w/in 48hr pt exp deafness & a balance disturbance;sx persisted as of 26OCT98;
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In 2014, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On unknown date, the patient experienced shingles (herpes zoster) and on 24-MAY-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Cold sweats and hot sweats and nausea. That evening I was so cold I couldn?t keep warn. On Friday afternoon the back of my knee was giving me a lot of pain. On Saturday I couldn?t tolerate the pain and went to emergency and diagnosed with a DVT. On 4/25/21 I was having pain and stiffness in both knees.
Patient left clinic after 30 minutes observation. Returned 40 minutes after receiving vaccine c/o numbness and tingling in his mouth and down his left side to his fingers. States this is the same reaction he has to his other allergies. ( he is prescribed an EpiPen but left it at his work)
Information has been received from a nurse practitioner concerning a 16 year old female who on 07-MAY-2007 was vaccinated with the 2nd dose in the left deltoid with Gardasil (lot # 657617/0384U). There was no concomitant medication. On 07-MAY-2007 the patient experienced rash and itchiness in the joint areas of the armpits, elbows, knees, and ankles which developed after 24 hours of getting the vaccine. The nurse stated that the patient had developed a similar rash when she ate mangos. Patient sought unspecified medical attention. The patient is being treated with steroid cream and has almost recovered. At the time of the report, the patient's rash and itchiness in the joint areas of the armpits, elbows, knees, and ankles had persisted. Additional information has been requested.
3RD DOSE MODERNA COVID VACCINE 11/04/2021, #076C21A; pt brought to Hospital after a fall; hit her head; no LOC; c/o neck pain; CXR showed pneumonia; CT of head showed moderate atrophy; transferred to MC; neurosurgical consult suggested c-collar to be worn x 3 months; DNR; pt did not qualify for SNF or hospice due to c-collar; 9/26/22 pt had a positive COVID test; pt's condition rapidly declined and she passed away in the hospital
This case was reported by a pharmacist and described the occurrence of eye swelling in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Historic vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given on an unspecified date. Concurrent vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified date the subject received 3rd dose of ENGERIX B (intramuscular, left deltoid). Within "a few hours" of vaccination with ENGERIX B, the subject experienced eye swelling. At the time of reporting the event was resolved. Per the reporter, the subject stated the swelling "went away after a few days." To the reporter's knowledge, the subject did visit her physician. According to the pharmacist, the subject's "physician said that it was a reaction to the vaccine" but the subject did not receive any intervention. The pharmacist reported two cases with ENGERIX B. See case A1013284A for details on the other case.
Paresthesia of L arm to L hand onset 1.5 hrs after receiving vaccine, lasted 2 days, no medication or treatment taken or received.
45 min. post vaccine experienced - fever, cough, headache & chills x4 days. Cough persisted x16+ days; symptoms worsen with each vaccine. Will no longer do annual flu vaccines.
Case's husband reported that case first tested positive for COVID 03/29/2022, went to a Rehab Hospital, developed blood in her urine so was admitted to hospital 04/01/2022.
Redness, irritation, and swelling around injection site. Pt saw MD, diagnosed with cellulitis. Treated with steroids and antibiotic.