chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ulcers; sore mouth; dryness; painful can't eat; crushing headache; Lips swollen; Lots of imflamation; This is a spontaneous report from a contactable consumer (patient, self-reported). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not provided), via an unspecified route of administration, in Arm Right, on 11Feb2021 at 15:45 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies-sulpha drug. Concomitant medications were not reported. The patient did not receive any vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 13Feb2021 at 12:00 AM, within 24 to 48 hours, she had a massive sore mouth, ulcers, dryness, and so painful couldn't eat. She also woke up with crushing headache. Her lips swollen and could not stand anything hardly warm on her lips and lots of imflamation. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the events. Outcome of the events was not recovered.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm, as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE; BUPROPION; LEVOTHYROXINE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 29May2022, outcome "recovered" (03Jun2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Clinical course: Patient did not had known allergies. Rebound of Covid positive home testing and sx on 29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Heavy Vaginal Breakthrough Bleeding May18th, 2022-POST MENAPAUSAL over a year PERIOD FREE! September 1st, 2022 Quad Flu Shot September 30th, 2022 Heavy Vaginal Bleeding November 17th, 2022 Phizer Booster Shot November 23rd-28th, 2022 Heavy Vaginal Bleeding
Discomfort at the injection site; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort at the injection site), MYALGIA (Body aches) and HEADACHE (Headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 04-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort at the injection site), MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort at the injection site), MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown.            No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
FACIAL PARALYSIS; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age, race and ethnic origin. 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, 1 total, administered on JUN-2021 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 JUL-2021, the patient experienced facial paralysis from last week after vaccination (second week of JUL-2021). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of facial paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210732631-Covid-19 vaccine ad26.cov2.s -Facial Paralysis. This event(s) is considered unassessable. 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).
"A nurse reported that a female pt, post vax, the next day, developed "severe" diarrhea. Stool specimen was tested for rotavirus but results were not provided. The pt recovered. No further information was provided. The reporter declined to identify the infant."
Approx 4hr. after recieving varicella vaccine the infant developed a fever of 102.6, lethargy & decreased appetite. On 9/20/2023 he developed red, itchy rash on arms/legs. As of 9/21/2023 rash spreading & now in throat. Benadryl ineffective - advised to use OTC Calamine lotion.
right upper quadrant pain; upper quadrant discomfort; Broke out in a rash; she developed a rash; Cardiac numbers are elevated; After she did her injection she started feeling bad; nausea; vomited; feeling sweaty; chest discomfort; diarrhea; gas; burping; She feels feverish; achy; Her temperature is 100.9ºF; chest pain; Numbness around mouth; Difficulty swallowing; This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no/Lot number: not reported) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization. Patient also received Inotersen sodium (TEGSEDI, injection) ongoing via subcutaneously on 29Aug2019 for hereditary neuropathic amyloidosis and diphenhydramine hydrochloride (BENADRYL ALLERGY) on an unspecified date for right upper quadrant pain and upper quadrant pain. ISSD (Integrated Syringe Safety Device) for unknown Indication from unknown therapy dates. Patient's medical history included as hereditary neuropathic amyloidosis. Concomitant medications were not reported. On 05Mar2021, patient experienced right upper quadrant pain, upper quadrant discomfort, broke out in a rash; she developed a rash, cardiac numbers are elevated, after she did her injection and she started feeling bad, had nausea, vomited, feeling sweaty, chest discomfort, developed diarrhea, gas, was also burping, she feels feverish, achy, her temperature is 100.9 F, chest pain, numbness around mouth and difficulty swallowing. Patient under lab tests and procedures which included cardiac function test and results noted elevated on 11Feb2021 and on 05Mar2021, body temperature increased results 100.9F. Outcome of the events Abdominal pain upper and Rash was not recovered, and other events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
Fever; Joint pain; Fatigued; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Oct2021 at 09:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 05Oct2021 at 22:45, the patient experienced fever, joint pain and fatigued. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, joint pain and fatigued was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Approx 1 hour after injection developed soreness and slight swelling at injection site. Approx 11 hours after injection - awoke at 06:00 on 3/23 with headache. Approx 18 hours after injection - 13:00 on 3/23, began experiencing unusual fatigue.  Approx 19 hours after injection - 14:00 on 3/23, experienced acute muscle soreness, especially in low back. Approx 19.5 hours after injection - 14:30 on 3/23, felt chilled, shivering, clothing touching skin was mildly painful. Approx 23 hours after injection - 18:00 on 3/23, came home from work and checked temperature - 99.8. Still experiencing all other symptoms listed above, took a nap for approx 30 minutes. Approx 25 hours after injection - 20:00 on 3/23, fever at 100.9. approx 26 hours after injection - 21:00 on 3/23, fever at 101.4. Approx 27 hours after injection - 22:00 on 3/23, fever at 101.9. All other symptoms continuing. Went to bed. Felt hot in the bed, but shivering. Restless sleep, awoke approximately 03:00 on 3/24 drenched in sweat, but feeling better. Approx 36 hours after injection - awoke 07:00 on 3/24, all symptoms gone except pain & swelling at injection site. This gradually diminished over 2 days.
Patient was given her third dose of the Covid Pfizer\BioNTech vaccine during a vaccine health clinic. First dose was given on 1/22/21, second dose on 2/12/21, and third dose on 3/5/21.   Patient had no known adverse reaction to her third dose.
I had swelling and tenderness in the armpit/lymph node area only on the same side that I had the shot.  It was not enough to be majorly concerned about, but the symptoms lasted 2-3 days.  Concerning enough that I was about to look into it when the symptoms went away on their own.  I have since talked to 3 other women who had the same exact side effect.  I am only reporting it because I think it is helpful to know that it is a possible side effect for women, instead of worrying that something else is wrong.
pt recv vax;to ofc visit & mom reported pt had rxn to last inject;devel high fever & delirium;
Pt called in afternoon same day of vaccine had a flu vaccine of fever. Next day pt had complained of back pain, nasal congestion. (Pt then told us that previously heart palpitation trouble breathing).
Patient developed pain in his upper left arm (injection site) later on in the day after receiving immunization. He also noticed redness that was warm to touch. The redness was not on the injection site, but below/into his under arm area. Did not spread or become itchy, did not have any respiratory issues. His only complaint was that his arm hurt. He presented to clinic x 2 days later (1/24/18).
Approximately 2 weeks post vax, the pt developed pain in hips, which migrated to shoulders, knees, and wrists. The pt awakened at night with pain. The pt has only one kidney due to renal carcinoma. Can't take NSAIDS
pt recvd vax; ran t of 101 x 3 days; pt screamed/cried x 6 hrs non stop;MD notified; told mom to call hlth dept;
Received shingle shot. Asked nurse if it would hurt. No, just like flu shot, it did hurt and burned. 03-19-09 4 AM difficulties breathing for 1 hr. Noticed itching all over body. later swelling of Lt arm got worse. Called nurse from home 03-20-09. Suggested urgent care, called Dr. got CEPHALEXIN 500 mg capsules for 10 days 4 times daily and cream. Swelling and dark red part is gone. Still itch (See attachment)
Began feeling ill approximately 27 hours after vaccination with fever, body aches, sore throat, joint pain, generalized weakness and confusion. Symptoms resolved on Day 3 (5/31/13) without treatment. Patient was advised to stop his LIPITOR and restart when symptoms resolved.
gen muscle pain & aches on 19OCT94, took ASA on 20OCT94 w/relief;25OCT94 cont to have muscular pain, but relieved by ASA;no other complaints;
Woke up at 1000 with severe body aches, sore neck, sore throat, mild headache, and nausea. Running a mild fever of 99.3F (baseline usually around 96.5-97.0). I took some Tylenol to elevate symptoms.
All was fine till day 9 evening when my right eye kept watering, and I brushed my teeth water shot out right side. Next day same thing with blurred speech. I went to hospital, had CT n MRI. No blood clot determined its bells palsy. I have been healthy accept for mild seasonal allergies
Tachycardia, parasthesia (up and down the line) 10 minutes after injection.  Heart rate 112 and irregular, 3 minutes later patient complained of tightness in her throat.  Patient refused ambulance transfer to ER. Medical records state warm, itching, reaction aggreviated. msv
This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored VAQTA (lot # L039659, exp date: 15-MAR-2017). The product was stored in temperature of 50.2 F degrees for 1 hour 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This was my booster shot. My last dose was 02/2021. I believe the adverse sx to be a very difficult menstrual cycle: a ton of bleeding and cramps for a longer amount of time. I haven?t had a period this heavy in at least 10 years.
Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA PNEUMOCOCCAL , EAR INFECTION (medically significant), SINUSITIS (medically significant), outcome "unknown" and all described as "Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series". The patient underwent the following laboratory tests and procedures: Antibody test: Negative, notes: Antibody titers negative after completed series.  Clinical course details: Recurring infection (ear sinus, and s pneumo). Antibody titers negative after completed series.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  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,Linked Report(s) : US-PFIZER INC-202300192340 same reporter/drug/event, different patient;
2 week hx of cough, bodyaches, headache, fever starting day post flu vaccine.
Sudden onset of inward deviation of L eye & hallucinations: feeling, spitting, seeing flies on body.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 03-AUG-2011, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 11-AUG-2013, the patient was treated by a physician at an internal medicine office for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 including 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Body Aches, soreness at site of injection, swelling at 10mm, warm, hot to touch. Student didn't return to clinic.  Notified clinic when she returned 3 days later for another appointment. No longer had discomfort. small swollen area 3-5mm jus below site. No discomfort.
After first shot, pt experienced sore neck and back, and while these were expected reactions to the shot I told her to contact her clinic if concerned. Later, she called reporting trouble breathing and neck swelling so I told her to get seen. Her symptoms resolved without needing care, she ended up canceling her inhaler. After discussing with her provider, she was given the OK to get second dose from us on 06/22/21.   The day after the dose (06/23/21) she said she experienced a full month of feeling fatigued, trouble breathing, and weakness. She ended up doing a telehealth visit with her primary on 07/21/21 and provider said it could have been a covid infection that was present before the vaccine was administered.  She was prescribed prednisone and inhaler and symptoms gradually resolved. She got her Flu shot with us on 10/07/21 without issue. Because of scarcity of information it is difficult to determine with certainty but this is more likely a case of covid infection that set in before vaccination, rather than an adverse reaction to the vaccine.
Patient stated that she has a rash around breast area on left side that travels to the back and it started 2-3 days after Fluzone High Dose was administered.  She is not sure if it correlates with immunization or not.
Information has been received from a physician concerning a male who was vaccinated "a few years ago" with Varivax. Subsequently the patient developed a "mild, wild-type rash". The physician also reported that "thee were only a few lesions, it was very mild." Unspecified medical attention was sought. Subsequently, the patient recovered from the "mild, wild-type rash". No product quality complaint was involved. Additional information has been requested.
sore left arm, nausea, headache, brief fever, about 36 hours, took aspirin
positive for COVID on 8/17/21; presented to ED with increasing dyspnea; hypoxic, chest with severe bilateral infiltrates; pneumonia due to COVID
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 24Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 06Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 14May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac Disease" (unspecified if ongoing); "Hashimoto's Disease" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; AMLODIPINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; METOPROLOL; VITAMIN D [COLECALCIFEROL]; ZINC; NAC [ACETYLCYSTEINE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course- Patient received Paxlovid for Treatment of COVID-19.
Received flu vaccine, egg and preservative free, Flucelvax. By the time I got home I had difficulty breathing/anaphylactic shock, wheezing, dizziness, red and hard injection site, fever. I had an injection pen due to severe food allergies and used it. My heart was racing. I continued to take benedryl for days when symptoms returned.