chrisvoncsefalvay/vaers-outcomes huggingface dataset:
note 24 Nov 2021 Patient is a 51 y.o. male who had left foot and mid calf pain mid August after initial moderna Covid vaccination on 26 July, he had his second dose of Covid vaccination on 23 August and the left mid calf pain that persisted did get worse, it had only been associated with some mild swelling however 3 weeks after his second dose it extended all the way up to his lower thigh and by early October he had groin pain and chest pain of the left lower lobe that was pleuritic associated with cough but it was improved with NSAIDs which he took for about a month until 11 November when he was noticing foot problems and significant swelling and came to the ER, he had TPA for extensive left lower extremity thrombosis with stent and was noted to have left lower lobe PE and segmental and subsegmental bilateral PE with some evidence of right heart strain, he was sent home on Eliquis 10 mg twice daily for a week and about as soon as he went to the 5 mg twice daily dosing left lower extremity symptoms worsened prompting current admission noting extensive clot to the left lower extremity with occlusion of recently placed stent.  He is currently on heparin drip and TPA.  This clot was exacerbated by Covid vaccination and other than being a man who is 51 years old he has no family history or other risk factors for thrombosis.  We can check a hyper coag work-up but I would avoid any future Covid vaccinations due to his history.   ?He will continue TPA and heparin drip, appreciate IR assistance ?When transitioning to anticoagulant once TPA is complete would give Lovenox 1 mg/kg twice daily while admitted and then 1.5 mg/kg daily (133 mg) upon discharge for likely at least 6 months, could use 150 mg dose, plus aspirin 81 mg daily ?Recommend starting aspirin 81 mg daily as soon as TPA has been completed and he transitions to his Lovenox  ?Hypercoagulable work-up that can be checked at this time includes factor V Leiden, prothrombin gene, beta-2 glycoprotein antibodies, anticardiolipin antibodies  ?Antithrombin cannot be checked while on heparin and will avoid checking DRVVT, and hexagonal lupus anticoagulant on heparin ?Protein S can be affected by acute clot, thus can check later ?He has had a colonoscopy and can keep these up-to-date through primary care, and PSA in August was 0.56 ?We discussed follow-up with me after discharge, they have information to arrange this as needed
Bright red, swelling, at vaccination site, unconsolable crying, irritable, vomited one time.  All symptoms occured 1.5 hours after vaccines given. Two doses of Tylenol were given, with no relief.  Symptoms persisted approximately 5-6 hours.  Twenty-four hours later, child was fussy, knot at site with redness, swelling was down and crying had stopped.  Parents took child to Pediatrician, no other treatment was given at the time.
Pt recvd a series of 3 Engerix-B vax doses 19MAR90, 13APR90 & 13SEP90 subsequently tested for Hep B antibodies & found not to have converted;
Injection site red, hard, tender 24 hours after injection.  Went to Emergency Room and was told site infected.  Given oral CEFUROXIME.
Pt. states that after receiving the 3rd dose of Moderna 11/26/2021, started experiencing symptoms 11/27/2021 (early morning) of fever (with Hallucinations), chills, and extreme fatigue. Lasting 8 hrs during early morning hours. Symptoms have subsided, No noted Primary visit/communications.
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 23-MAR-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis.          The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002973: US-009507513-2104USA002971: US-009507513-2104USA002963: US-009507513-2104USA002972: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Feeling like I might vomit; Dry heaving; Cramping; Stomach ache; Headache; Generally feeling sick.; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 08Oct2021 at 13:45 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included leg ulcer, cellulitis, high blood pressure, high cholesterol, overweight and mersa (infection MRSA - methicillin-resistant Staphylococcus aureus). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included about 14 prescriptions, high blood pressure medications (unspecified) from unknown dates and unknown if on going. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Oct2021 at 13:00, the patient was feeling like she might vomit, dry heaving, cramping, stomach ache, headache and generally feeling sick. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events feeling like she might vomit, dry heaving, cramping, stomach ache, headache and generally feeling sick was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the military. 2021:e212833     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms.   Company Comment: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-245527, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
pt recvd vax & 5 to 10 mins later pt exp bradycardia & weakness; pulse rate dropped from 80 to 50; sx resolved w/in 20 minutes; No further details were provided
a dose of improperly stored dose of PROQUAD was administered; no adverse event; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T034614 exp date 10-APR-2022) (0.5 mL and route not reported) that was stored during a temperature excursion found supported on 16-SEP-2021. The temperature of excursion was 6°F to 14°F (8.5 °F) for 18 minutes and 6°F to 14°F (11.9 °F) for 1 hour. Cumulative timeframe was 1 hour and 18 minutes. There was no previous temperature excursion.
This case was reported by a physician via a sales representative and described the occurrence of fever in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX (1 ml, oral). 1 day after vaccination with ROTARIX, the subject experienced fever and diarrhea. The subject's parents contacted the physician who referred the subject to the emergency room for evaluation. At the time of reporting the outcome of the events were unspecified. The physician considered the events were possibly related to vaccination with ROTARIX. Follow up was received from physician on 29 March 2013. The physician reported concurrent vaccination included DTaP+HepB+IPV (GlaxoSmithKline; intramuscular; unknown given on 5 March 2013; Hib (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 5 march 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; intramuscular; unknown give 5 March 2013. Per the physician, on 5 March 2013 the subject received 1st dose of ROTARIX (1 ml, oral). On 5 March 2013, less than one day after vaccination with ROTARIX, the subject experienced fever and diarrhea. The physician reported that the subject "developed a fever of 102 degrees Fahrenheit on the night of 5 March 2013 after receiving vaccine. Also developed diarrhea." The physician also reported that there was no medical history or concurrent illness that could have been associated with the events. The physician also stated that the subject was "well and asymptomatic prior to vaccine administration." Relevant test results included on 5 March 2013: Complete Blood Count with white blood cell count of 13.3, Blood Culture with result "positive for staph (contaminant)". On 7 March 2013, the subject received a urinalysis with normal result and urine culture with negative result. The physician also documented that on 8 March 2013, 4 days after events onset, the events were resolved. The physician also documented that the adverse events resolved on 7 March 2013, 3 days after events onset. The physician identified ROTARIX as the suspect product. The physician did not consider this case serious. The physician indicated that the subject did not have a congenital defect. The physician also documented that due to the adverse events, the subject was not hospitalized or jeopardized or required intervention. The physician considered the events were possibly related to vaccination with ROTARIX.
I had a fever of 101. I took Tylenol for the fever, and it was not breaking. I also had body aches, fatigue, cough, and sore throat. I tested myself for COVID-19 and it came up positive. I felt better on day three but I did have a cough, nose and chest congestion. I finally called my doctor, and she gave me an antibiotic.
UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 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 subject experienced unspecified adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified adverse events. This report was non-serious.
Fever, chills, body aches, lose of appetite, lethargy, pain, redness and swelling at site of injection, headaches, sweating during sleep, starting the morning after receiving vaccine and lasting approximately 72 hours. Redness and pain at injection site, sweating during sleep, has continued past 72 hours, but other symptoms have subsided. Took ibuprofen and acetaminophen during first 72 hours fairly consistently to reduce fever and aches.
The following day her lymph nodes under her left arm (injection side) in the armpit swelled slightly large.  It was noticeable even with her arm down.  The swelling took 2 days to go down.  She only got a slight headache and slight ache from vaccine and no fever.
Redness, pain, elevated temperature and swelling at the injection site.  Symptoms were present approximately 5 to 6 hours after injection.  Slept more than usual.  Woke up next day with more pain, redness, elevated temperature and swelling at the injection site.  Used Vicks vapor rub and Salompass pads to control pain and discomfort.  Symptoms were gone by the third day.
Menactra vaccine was administered a day after the expiration/No AE; Initial information was received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse .   This case involves a 11 years old male patient who was vaccinated with 0.5 mL dose of expired vaccine  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA (lot U5869AD and expiry date 05-Aug-2020) via intramuscular route in the right deltoid for prophylactic vaccination on 06-Aug-2020 (expired product administered)   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE (HPV VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used. Vaccine was administered a day after the expiration date.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever 102 2APR91 rash - red macular, varying sizes - both thighs & rt chest; Both knees red & swollen; 3APR91; TX: Benadryl 1/2 tsp QID;
Redness/swelling spreading down vaccinated arm onto chest. Significant edema present at posterior elbow into forearm.
Injection site red hard ball about 2" in diameter for about two weeks. Painful, itchy, nausueas and diarrhea.  About a week later I had severe arm pain from my back down my arm to my hand, which continues at a lesser degree two months later. I visited my primary care doctor today and she noted that I still have a small nodule in that arm. It becomes painful when aggravated such as being touched or use my arm much to work. I believe I am not a good candidate for shot #2.
pain; This is a spontaneous report from a non-contactable consumer (patient's sister) received via a Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 16Feb2021 (Batch/Lot number: not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced pain after having her first dose of the vaccine. The reporter wanted to know if the patient could take ibuprofen (MOTRIN). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient contracted and tested positive; patient contracted and tested positive; had a headache for a day; This is a Non-Interventional report from Facilitated Collect based on the information received by Pfizer from Regulatory Authority (MFR Control No. 21K-163-4090044-00) from a contactable consumer (patient).   A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Jan2021 (Batch/Lot number was not reported), intramuscular, and the second dose in Feb2021 (Batch/Lot number was not reported) intramuscular as single dose for covid-19 immunisation (both doses at the age of 55); upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced patient contracted and tested positive (covid-19) on 02Sep2021, had a headache for a day on Feb2021. The patient was hospitalized for patient contracted and tested positive (covid-19) for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Sep2021. The action taken in response to the event(s) for upadacitinib was unknown. Headache recovered in Feb2021. The outcome of the other events was recovering.  The reporter's causality for the events COVID-19 and headache of Rinvoq (Upadacitinib): no reasonable possibility.  The reporter's causality for the events COVID-19 and headache of Pfizer Biontech COVID-19 vaccine: No reasonable possibility.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Vaccination failure, Covid-19 and Headache (non-serious) and BNT162B2.
Shingles to right upper chest, shoulder, ear and neck Treated with Valtrex, Lyrica, calamine and silvadene cream.
Dec 12 received both the influenza and anthrax vaccine 1500 hrs. Returned home at 2300 hrs. Ate a sandwich and prepared for bed. Other than feeling a little achy and tired reported no problems and denied fever. Went to bed at 2400 and feel asleep immediately. Next thing he remembers is awakening at 0030. Has no recall of events for the previous 30 min.  Pt states that his wife reported that he started to shake gradually all over his body and that she was unable to wake him up so she called 911. Stated that shaking lasted 30 60 sec. and that the 911 operator told his wife to place him on his side. Stated that he was gurgling and that breathing was laboured. Reported that he had a small amount of emesis.  Was transported to hospital, blood and urine tests were normal and he was later released at 0500.  Pt denies any incontinence, no trauma to mouth. Never had anything like this before and that he is currently feeling fine.
Developed severe h/a; t100, sx began 25MAY91 treated at Hosp; According to father was viral encephalitis but data indicated aseptic meningitis;
Lose sight in my left eye; Weakness; Heaviness in my legs/feet; Chills; Low grade fever; Neuoromyelitis Optica; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8729, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 08Apr2021 at 10:00 as dose 2, single (at the age of 47-years-old) for covid-19 immunisation. Medical history included vitiligo and known allergies to some raw fruits & vegetables and known allergies to penicillin. Patient received no other vaccines in four weeks. Concomitant medications or other medications in two weeks included pantoprazole, pimecrolimus (Elidel) and boron, calcium, Cimicifuga racemosa extract, folic acid, glycine max extract, Magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin B12 NOS (Estroven). Patient was not diagnosed with COVID prior vaccination. Historical vaccination included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 18Mar2021at 09:30 hours as dose 1, single for covid-19 immunisation and had no reaction on previous exposure to drug. Patient was COVID tested post vaccination by nasal swab and result was negative. On 09Apr2021 (the day after the second dose), patient had chills, low grade fever. On 13Apr2021 (4 days after the second dose, patient began to had weakness and heaviness in her legs/feet and by 16Apr2021, patient began to lose sight in her left eye and had to be hospitalized for a week. Patient received high dose of steroids and had to have plasma exchange (plasmapheresis) for an antibody (Neuoromyelitis Optica) that was triggered in her system, as treatment for all the events. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Event lose sight in her left eye was considered as serious (hospitalization and disability) by the reporter. The outcome of all the event was recovering.
C/o dizziness and stomach ache with vomiting. Monitored for approx 1 hr. Cont to vomit clear/yellow liquid. TC to mom to pick up. Advised to watch, keep hydrated & contact PCP if sx cont/worsen.