chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This spontaneous report from a contactable nurse reporting same events under the same suspect product for 19 patients. This is one of 19 reports. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced positive with COVID-19 on 03May2021. It was reported that 19 residents in the  facility where the reporter work were fully vaccinated and are positive with COVID-19. Some were not doing well at all. The events was serious for being hospitalization, life threatening. The events result in Emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19 on 03May2021 with positive result. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.    There is limited information provided in this report.  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.,Linked Report(s) : US-PFIZER INC-2021548296 same reporter, vaccine and AE, different patient
Two hours after receiving immunizations, mother found infant in her crib with her eyes rolled back, gagging with some frothing at the mouth.  No change of color observed by mom (who is a nurse).  No shaking or jitters were observed.  Mom tried to wake the infant & after 1 minute patient returned to normal state.  Afebrile.  Infant is breatstfed &supplemented with formula- spits up occasionally.  Hospitalized for 2 days.  Developed fever of 102F in the hospital- attributed to immunizations and responsive to Tylenol.  No episodes of seizures, choking or apnea in hospital.  Discharged afebrile and on no meds. 3/28/06 Received d/c summary from hospital which revealed patient experienced fever, choking, gagging, eye rolling & fothing at mouth.  Fever subsided after 2 days w/o antibiotics.  No further seizures or further choking observed & no apnea/ss
Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Client requested his Jynneos vaccine today. PHN, assessed the client on foot team on the side of the street. During assessment, client denied history of syncope or nausea with injections and completed the pre-screening checklist with no precautions or contraindications. At 11:30 pm client received Jynneos monkeypox vaccine Lot# FDP00014 BUD: 11/10/2022 ID in the left arm. At 11:35 am client stated he was feeling a little "lightheaded." PHN  gave client water to drink and supported client to a sitting position, client refused to lie down. Vitals taken at 11:42 am HR 68 bpm, SPo2 96%, BP 150/98, RR 18. Client denied headache, nausea, blurry vision. Client confirmed continued to feel a "tiny bit" lightheaded. Client alert and oriented to person, place, time and situation. Client denied any chronic health condition, denied taking medications. At 11:43 am client ate crackers. Client stated that he "always feels this way after shots." At 11: 48 am vitals taken, BP 140/92. Client stated not feeling lightheaded anymore and he felt "fine." Client stood up at 11:50 am and walked away before PHN could finish education. Client walked away with a steady gait.
weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some difficulty with breathing; This is a spontaneous report from Medical information team. A contactable consumer (patients daughter) reported that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 Immunization. It was reported patient experienced side effects include, weakness, muscle pain, tiredness. Her mother has not been feeling well. She does not feel 100% today. She was calling to see if these symptoms are related to the shot. Her mother has experienced tiredness, headache, muscle pain, nausea, feeling unwell, vomiting, some difficulty with breathing. She was sitting up currently and was fine but was not 100%. She also has weakness. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Really bad pain in her right leg, pain in the foot, barely any pain in her left leg; Pain in the ankle; Injection area is red; Injection area is hot to the touch; Injection area itches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really bad pain in her right leg, pain in the foot, barely any pain in her left leg), ARTHRALGIA (Pain in the ankle), INJECTION SITE ERYTHEMA (Injection area is red), INJECTION SITE WARMTH (Injection area is hot to the touch) and INJECTION SITE PRURITUS (Injection area itches) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Really bad pain in her right leg, pain in the foot, barely any pain in her left leg), ARTHRALGIA (Pain in the ankle), INJECTION SITE ERYTHEMA (Injection area is red), INJECTION SITE WARMTH (Injection area is hot to the touch) and INJECTION SITE PRURITUS (Injection area itches). At the time of the report, PAIN IN EXTREMITY (Really bad pain in her right leg, pain in the foot, barely any pain in her left leg), ARTHRALGIA (Pain in the ankle), INJECTION SITE ERYTHEMA (Injection area is red), INJECTION SITE WARMTH (Injection area is hot to the touch) and INJECTION SITE PRURITUS (Injection area itches) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-304337.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event was reported).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Janssen COVID-19 Vaccine EUA Bad headache, fever, body aches, neck pain, eye pain.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 3:Pfizer /Dose Number: 2:Moderna / Dose Number: 1:Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Lot number: 027A21A) and on 08Apr2021 as dose 2, single (Lot number: 036B21A) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "asthma" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Nov2021, outcome "recovered", described as "Dose Number: 3:Pfizer /Dose Number: 2:Moderna / Dose Number: 1:Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Oct2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Took Paxlovid and tested negative on day 7; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 30Sep2022 to 05Oct2022, for the treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diplopia, lower extremity weakness and numbness, decreased reflexes, urinary retention/hesitancy
Immediately after giving vaccine, erythema of 8 cm appeared and began to spread. The patient began to cough, gag and drool. The nurse practitioner administered epinephrine IM after seeing a compromised airway. Pt. began to move air better and turn pink. Pt given dexamethasone 8 mg IM and admitted for 23 hr observation.  7/15/2008 MR received for DOS 6/10/2008 with D/C DX:  Anaphylaxis after MMR vaccine. Immediatley after MMR surrounding area became red, face turned red, Pt coughing and unable to catch breath. (+) stridor. Tx with epipen, O2, Steroids and Benadryl with resolution
Dose was the booster on 10/8/2021.  Felt pain on Sunday, 10/10/2021.  Delayed going to Dr. as I was waiting for a regular appointment scheduled (3-4 weeks later).  After waiting 1 week, opted to go to urgent care (10/18/2021) due to constant pain in left chest with shifting forward (bending) causes more pain.  Pain also radiates to back and breathing was a bit more shallow.    Urgent care sent me to ER the same day.  ER notes indicated incorrect date in notes, indicating "just a date sometime close is fine".  Outcome:  Trace left pleural effusion (was not on any prior CTs).
Pt's arm felt heavy and fingers tingled and felt numb shortly after immunization was administered.
Pain started in her wrist on 6/8/16 and every day thereafter pain in another joint. By 7th day she was completely bedridden in extreme pain. Took her to several Drs and hospitals still no answers and still no improvement.
Patient came in and complained of a swollen right lymphnode in neck. She said it felt like a round lump. I recommended that she follow up with her primary care provider
Information has been received from a physician concerning a female who was vaccianted with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. It was reported that the patients brother (WAES0506USA02745) had a similar experienced after vaccination with varicella virus vaccine live. Follow up information from a health professional indicated that there was no additional information. Additional information is not expected.
developed hives/breaking out in hives all over; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed hives/breaking out in hives all over) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 027C21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovary.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced URTICARIA (developed hives/breaking out in hives all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and CORTISONE (topical) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (developed hives/breaking out in hives all over) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medication include birth control pills for polycystic ovary. And also reported has no new products added to their routine.
Itching on the tops and sides of feet, on kneecaps, backs of hands, under armpits, and on chest/torso
p/vax pt devel a fever;pt recovered. It was reported, "A nurse reported that a 2 month old male received Acel-Imune, Hib-Titer, IPV, and hep B vaccines and subsequently developed a fever. The infant recovered. From additional info received on 9/15/99, it was reported that there is a duplication of this report. Additional pt, vaccien and responsible physician info were also provided. Follow up 8/5/02: during internal review of all files, it was deemed to amend the report by updating the product section (deleted hep B and added RotaShield). Also checked the required intervention box for ER visit.
Janssen COVID vaccine administered to 15 year old client by LPN.  Client did not meet  current age requirement to receive Janssen COVID vaccine.  No adverse reaction noted after 15 minte oberservation. Instructed father and client to contiue to monitor for adverse reactions. Return to clinic or ER as needed.
Per mother child received vaccines Monday March 17 and yesterday was concerned because noticed left arm (deltoid) with redness and swelling. Per mother had never seen this happen to any of her other children so she was concerned. Per mother applied warm compress to child's arm for comfort. Denies numbness or tingling to left arm or extremities. Follow up phone call 3/20/08. Mother stated child's arm better.
high tempeture, sweats, chills, upset stomach, vomiting, arm swelling at injection site
p/vax pt devel fever, cough, rhinorrhea & then devel morbilliform rash;
Left arm/ shoulder pain; Left arm/ shoulder pain; This is a spontaneous report received from a Non-contactable other health care professional (patient).  A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ELO140), via an unspecified route of administration, administered in Arm Left on 24Dec2020 (age at the time of vaccination was 33-year-old) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient had no known allergies. Patient has not received any other vaccines in four weeks and not received any other vaccines prior to vaccination. On 15Feb2021 (post vaccination) The patient underwent lab tests and procedures which included sars-cov-2 test and resulted as negative. On 24Dec2020 the patient experienced left arm/ shoulder pain (pain in extremity), left arm/ shoulder pain (arthralgia) persisting since the first vaccination it has never gone away. Patient had no other injury to that arm other than the vaccine which resulted in doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered. No follow up attempts are Possible. No further information is expected.
Per nurse, pt called 3/14/19 - 1243 stating he had the following reaction to vaccine: Pain, redness and soreness at injection site. HA, Fever of 101.6, muscle aches, shivering, fatigue, and nausea. States to be feeling much room/doctor visit better on day of call, and reported temp of 99.0. States he had been taking TYLENOL for fever. Nurse provided ER precautions to pt and informed pt to call back if symptoms should worsen.
Severe upper arm pain of the left arm and nausea;  Patient called ambulance to pick her up to take her to ER; Hospital gave prescription for Hydrocodone/APAP and Zofran;  Hospital ordered X-Ray.
30 Year old male with symptoms of nausea, abdominal pain, diapheria and diarhea times three days. Seen at civilian clinic and given 2 liters iv fluid.
Pain was radiating to her chest & chest pain; Trouble breathing/a little diffeculty breathing; Arm was swollen; Arm was really sore; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Pain was radiating to her chest & chest pain), DYSPNOEA (Trouble breathing/a little diffeculty breathing), VACCINATION SITE SWELLING (Arm was swollen) and VACCINATION SITE PAIN (Arm was really sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain was radiating to her chest & chest pain), DYSPNOEA (Trouble breathing/a little diffeculty breathing), VACCINATION SITE SWELLING (Arm was swollen) and VACCINATION SITE PAIN (Arm was really sore). At the time of the report, CHEST PAIN (Pain was radiating to her chest & chest pain), DYSPNOEA (Trouble breathing/a little diffeculty breathing), VACCINATION SITE SWELLING (Arm was swollen) and VACCINATION SITE PAIN (Arm was really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medicine include Baby aspirin one day   Treatment information was not provided
Redness, pain, fever, nausea, muscle aches, pain, cramping, rash, severe migraine, redness and swelling at vaccine site and redness and severe pain on chest on same side of vaccine, cannot move arm without servere pain. Migraine scale over 10, vaccine and chest pain 5 if not moving. This lasted from Wednesday evening and Saturday (today)first day no fever and actually out of bed. Called DR on Friday told if still running fever Saturday go to Urgent care, broke fever 1:30 this am. Missed 2 entire days of work and am still in pain, still have redness, swelling, rash and pain. Migraine comes and goes.
Had to wear a heart monitor due to heart palpitations, now I have Supraventricular tachycardia (SVT), a heart condition
Dizziness lightheaded Narrative: V/S checked. Observed for 30 minutes.  Felt better.
Patient states had 4 inch diameter redness/rash around injection site that was red/swelling/itchy. Patient experienced minor discomfort, but was fine after a week, the rash at injection site went away.
Fever (Max 100.6 Fahrenheit), chills, body aches, headache - began around midnight following dose, fever broke around 11am the following morning. Took ibuprofen 800mg around 6am.
Left upper red and swollen within 30 minutes of injection. Minor redness at site remains 10/28/04. No medical treatment administered.
Hives and migraine after receiving flu vaccine. Felt flushed and developed hives (wheals) on her trunk and neck. No SOB, dysphagia, wheeze, tongue swelling.
Report received from a pharmacist on 14-OCT-2010 (via distributor 1010USA01788). A female patient (unknown age/date of birth) received a 0.5ml dose of AFLURIA (Lot#M52508, EXP: 30-JUN-2011) via intramuscular administration for immunization on 14-OCT-2010. The patient had no pertinent medical history or drug reactions/allergies. On 14-OCT-2010 (unknown time to event onset), the same day after receiving AFLURIA, the patient developed nausea and vomiting and reporting that her head felt "weird". Treatment medication was not reported. At the time of reporting the patient had not recovered from the events. No further information at this time. The case was reported as non-serious. The reporter did not provide a causality assessment in relation to the suspect drug, AFLURIA. The company considered events non-serious and possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product. Data entry correction (10-DEC-2010): country changed.
Swollen, red, warm, local reaction at site on left leg x 3 days. Pt was admit to hospital.
Information has been received from a RN concerning a 79 yr old female with diuresis, high blood pressure, thyroid disorder, chronic obstructive pulmonary disease, and allergy to codeine who in November 1996 and on 14Sep04 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Concomitant therapy included an unspecified diuretic, unspecified high blood pressure medication, potassium, unspecified thyroid medication, unspecified inhaler for COPD and lansoprazole (Prevacid). On 16Sep04 the pt developed a red and swollen arm. The doctor ordered warm compresses. No product quality complaint involved. It was also reported that another pt had a similar reaction (WAES0409USA02643). Additional information has been requested.
developed hearing loss in his right ear; This is a spontaneous report from a contactable consumer (patient's parent).  A 15-year-old male patient (reporter's son) received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter's family and reporter had all been vaccinated with BNT162B2, about 6 to 7 weeks later reporter's son who was a healthy 15-year-old developed hearing loss in his right ear. Reporter had sent him to an ear, nose, and throat (ENT), he was on steroids medication, but he still had not recovered the doctors could not figure out why he lost his hearing. Reporter had spoken to several others who have lost their hearing after testing positive with COVID. Reporter liked to speak with someone regarding a connection. Therapeutic measures were taken as a result of event and included treatment with steroids. The outcome of event was not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.