chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 68 year old male with pulmonary problems (not specified) who on 20-DEC-2006 was vaccinated with Pneumovax 23 (Lot # 655499/0988F). It was reported that the patient presented back to the office on 21-DEC-2006 with fever and an injection site reaction which was sore, red, and swollen. At the time injection site reaction which was sore, red, and swollen. At the time of the report, the patient had recovered (date unknown). A lot checked of concern has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Patient received dose at approx 4:10. Patient passed out at approx 4:14pm. Patient was revived in approx 2 minutes. HR-45, BP-90/48, temp 99.2, Pulse ox  approx 85%. Patient given water. after 5 minutes HR 65, BP-110/60, Pulse ox 92+. Patient remained for several minutes and taken home by Mom(a nurse). Patient reported by Mom to be fully recovered  after 5 hrs. Vaso-Vegal ?
Case number PHEH2015US024717 is an initial spontaneous report received from a nurse on 23 Nov 2015. This report refers to an 88 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174085) intramuscularly on 07 Oct 2015. It was reported that while removing air from syringe 2/3 of the dose leaked out and hence patient did not receive the full dose of vaccine. No adverse event was reported following this maladministration.
Patient presents 4/17/17 for missed periods (skipped 2-3 mos prior)was "regular". She also complains of fatigue, abdominal discomfort, appetite changes some wrist pain. Mother says onset was after her HPV vaccine. Screening labs pending. Thyroid, CBV, Celiac; Iron studies, hormones. Exam unremarkable.
Developed burning sensation at the bottom of my feet that has not subsided and skin on the inside of my palms begin to peeled.
Closed fracture of neck of right femur - PROCEDURE: Right - right hip HEMIARTHROPLASTY; patient was hospitalized for a total of 5 nights following the surgical procedure. The hospitalization was necessary for pain control, therapy, medical care and discharge placement. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine. Re-admitted 2 days later  with sepsis and lower GI bleed. He underwent flex sigmoidoscopy and clipping of internal hemorrhoid, following by surgical over-sewing of hemorrhoidal vessel on 12/1/21.
DONOR REPORTED BEING ILL FOR ONE WEEK WITH FEVER, THROWING UP AND RUNNING NOSE.
Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive impaired, dizzy, disoriented
Patient was hospitalized for breakthrough infection. Patient received Pfizer vaccine (2nd dose in series) on 04/23/2021. Patient was hospitalized from 10/30/21 - 11/11/21. Below is copied from patient discharge summary:   55 yo female admitted with acute hypoxic respiratory failure secondary to COVID-19.  Had prolonged course secondary to persistent hypoxia requiring HFNC and BiPAP therapy.  She was also found to have Strep pneumoniae positive infection in which she was treated with antibiotics.  She has continued to be weaned down from o2 to now only requiring 2-3L NC.  Patient now meeting criteria for discharge and desires home discharge with home health and home O2 which have been coordinated for discharge today.  Plan for discharge today with follow up with PCP.
Possible hearing impairing following vaccination; Covid Arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Covid Arm) and HYPOACUSIS (Possible hearing impairing following vaccination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included GLUCOSAMINE, CALCIUM and FISH OIL for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm). On an unknown date, the patient experienced HYPOACUSIS (Possible hearing impairing following vaccination). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site reaction, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Vaccination site reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid Arm) had not resolved and HYPOACUSIS (Possible hearing impairing following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The dermatologist reported to VAERS and gave patient  topical steroid.   This case was linked to MOD-2021-028281 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant follow-up received.
Patient did not report adverse even to me until 1/14/2020, when I called to remind her to come in for the second dose. She proceeded to inform me that the first one made her arm swell rather large (which lasted close to a month) and that she felt "sick" (tired, aches, headache) for the entire weekend after getting. It caused her to miss a wedding she was to attend. At the advise of her allergist, she said she will no longer get "any" vaccines in the future.
7 day after site itching, hot swelling. Unsure if related 9 day after suffered CVA and have hyper coagulation
Two hours after the vaccine I took two ibuprofen to prevent any symptoms, the next morning I had swelling. I waited two weeks to see a physician about the swelling, my appointment was on 02/22/2022. I had pain from the knee down to my ankle area, my leg felt restless and I had problems walking. I went to the walk in clinic for further evaluation and had blood work and ultrasound. It was confirmed, I had a blood clot and was prescribed Xarelto. I went for a follow up on 03/25/2022, the blood clot is still there and I was told to continue to keep taking the prescribed medication and wear compression stockings. I've also been referred to see a hematologist for further evaluation on 04/18/2022.
given ADACEL as a prophylaxis for a laceration with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was given adacel as a prophylaxis for a laceration with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included CEFDINIR (OMNICEF [CEFDINIR]).  On 20-Oct-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once (lot U7626AA and expiry date: 08-Dec-2024) via intramuscular route in the left arm for prophylaxis for a laceration.  On 20-Oct-2022, (latency: same day) the patient was given adacel as a prophylaxis for a laceration with no reported adverse event (off label use).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.
rashes at the area of the injection; itchiness at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rashes at the area of the injection) and INJECTION SITE PRURITUS (itchiness at the area of the injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042620A and 030M20A) for COVID-19 vaccination.     No medical history reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE RASH (rashes at the area of the injection) and INJECTION SITE PRURITUS (itchiness at the area of the injection). At the time of the report, VACCINATION SITE RASH (rashes at the area of the injection) and INJECTION SITE PRURITUS (itchiness at the area of the injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not specified.  No treatment information was provided.
I received the Moderna Bivalent booster on 10/7/2022. When I went to bed on the night of 11/2/2022, I had a low-grade fever and nasal congestion. During the night, my nose ran continuously. I then developed a dry cough. I got up at about 5 AM on the morning of 11/3/2022 to see what the symptoms of COVID-19 are. After I found out what they are, I decided to take a home test, which yielded a positive result. I have been self-isolating ever since. Today marks the sixth day of isolation for me. I took another home test this morning and got another positive result. On 11/3/2022, I called my doctor to inform her of the situation. She decided not to prescribe me any medication, such as PAXLOVID, as she feared that there would be a negative interaction with the XARELTO I take. Since I couldn't get any prescription medication for COVID-19, I have been treating my symptoms with OTC DELSYM for the cough and OTC diphenhydramine for the discomfort. I have found them to be helpful.
Blurry vision; dry mouth; light sensitivity; migraine headache; swollen lymph nodes on right side of collarbone; diarrhea; infrequent chills; injection site pain; injection site muscle pain; tired; This is a spontaneous report from a contactable consumer. This 49-year-old adult non pregnant Caucasian female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, batch/lot number: EN6200) via unknown route of administration in Right arm on 16Feb2021 at 01:45 PM (at the age of 49 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included asthma, copd, pre-diabetes and allergic to walnuts, pecans, cottonseed, blue cheese, feta cheese, portabella, mushrooms. The concomitant medications in two weeks included montelukast, budesonide, formoterol fumarate (SYMBICORT), levonorgestrel (MIRENA). The patient was non pregnant. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, batch/lot number: EL9264) via unknown route of administration in Right arm on 26Jan2021 at 01:45 PM as DOSE 1, SINGLE for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient not had COVID prior vaccination. On 16Feb2021 at 03:00 PM, the patient experienced blurry vision periodically, migraine headache, light sensitivity, tired, swollen lymph nodes on right side of collarbone, diarrhea, infrequent chills, injection site pain, injection site muscle pain, dry mouth. No treatment was received. The patient was not tested COVID post vaccination. At the time of this report the outcome of the events were reported as recovering.  Follow-up (27May2021): Follow-up attempts completed. No further information expected.
Miscarried approximately 2 weeks after receiving the flu vaccine. Baby had been scanned and tested prior to vaccine, had a heartbeat and no genetic abnormalities at time of ultrasound.
A spontaneous report has been received from a physician regarding a 28 year old male patient who completed (Merck) VARIVAX immunization series at age 12. He had a titer drawn for varicella zoster virus (VZV) in 2014 (specific date unspecified) and the results came back as "equivocal" with level of 1.09. Medical history included allergic rhinitis. Concomitant medication included proton pump inhibitor (not further specified) and generic FLONASE. Patient's present status was reported as "not recovered". No additional information was provided. Additional information has been requested.
per phone call from pt tingling & numbness in rt arm & nl arm soreness then 3 days p/rt arm pain moved to rt shoulder & jaw area; took APAP; enamel on 1 tooth was aching;
Chest tightness, shortness of breath, nausea and vomiting 8:45pm increasingly worse until about 11:30pm with acetaminophen and Zofran.
Vaccine - PREVNAR 13 was administered to child who is 5 yrs 4 mos. Which was not required for school entry.
Information has been received from a nurse practitioner concerning a 20 year old female (141 lbs) qith no known drug allergies and a history of asthma when younger, who on 05-APR-2007 was vaccinated with the first dose of Gardasil vaccine. The patient was vaccinated in the left deltoid with the third dose of Gardasil (lot# 0530U) on 15-OCT-2007. Concomitant therapy included Ortho Tri-Cyclen. When the patient received the first and second dose of Gardasil vaccine, she experienced minimal pain, what would be expected after getting an injection. On 15-OCT-2007, after the third dose of Gardasil vaccine, the patient experienced pain at the injection site at rest and had a limited range of motion. The patient could not raise her arm higher than shoulder level. There was no illness reported at the time of vaccination. The patient's pain at the injection site at rest and not being raise her arm higher than shoulder level persisted. Additional information has been requested.  Follow up information was received on 27-NOV-2007 from the nurse practitioner who reported that on 25-OCT-2007, the patient consulted with the primary caregiver physician's assistant and the patient used antiinflammatory drug to return full range of motion. On 20-NOV-2007, the patient recovered full range of motion. The patient's soreness persisted and the pain lessened in severity.  Additional information is not expected.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a physician regarding a 5 year old female patient who received a second dose on 1/24/05 and experienced redness and itching over her whole body, and swelling of the face. The patient's concurrent illnesses include eczema and lactose intolerance. Indication for Prevnar was immunization. Product was administered on 1/24/05. Dose regimen was 0.5ml 1 time per day (IM). Patient was not taking concomitant therapy. The patient received a second dose of Prevnar on 1/24/05, and one hour later, developed redness and itching over her whole body and swelling of the face. Epinephrine and steroids were administered in the emergency room, on 1/24/05, but the patient was not admitted to the hospital. The reporter stated that the child is lactose intolerant, and at 0800 AM on 1/24/05, ate cereal which may have contained dried milk. The patient recovered. No additional information was available at the time of this report.
Itchy rash behind left knee onset at night, in the morning diarrhea X2, morning mild headache took ibuprofen, red itchy rash appeared on right leg then later in the morning on her face and around noon on her back. No more diarrhea since the morning. Ibuprofen Around noon eyes felt dry/itchy. About 1PM given generic Zyrtec one tablet orally.
Muscle aches; injection site soreness; runny nose/congestion; runny nose/congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 26 years as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Muscle aches"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness"; RHINORRHOEA (non-serious), NASAL CONGESTION (non-serious), outcome "unknown" and all described as "runny nose/congestion". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & mom reported pt feverish & shaky but MD never stated it was adverse rxn & ?pertussis poss rxn;nurse noted blinking eyes;pale sl in face;fuzzy vision/sl ringing in ears;BP 98/42;leg weak, tired feeling;BP 110/60;shot site hurts
Patient with COVID vaccines who admitted to hospital with COVID detected test.  Provider d/c note:  " 63 YO female who presented to the hospital with shortness of breath and chest pain. The patient was found to have severe CAD, decompensated severe ischemic cardiomyopathy, and acute on chronic renal failure. Cardiac catheterization revealed 3 vessel CAD with EF of 25%. She was recommended for CABG. After a period of optimal medical management including initiation of hemodialysis, the patient was brought to the operating room and underwent CABG x 4 on 11/14/2022. She tolerated the surgery well. The patient was monitored in the ICU and PCU setting. She continued to undergo hemodialysis. The patient worked with therapy on a daily basis. She was discharged home with HHC and therapies in stable condition on postoperative day 12. The patient has difficult to control DM type I and had adjustments to her insulin regimen throughout the hospital course. She will follow up with endocrinology as a outpatient. "
Tdap given 1/20/16. Developed rash about 3 days after. Pt. seen by doctor 1/27/16. Localized redness around injection site that is resolving. Recommendation to apply heat or ice and return as needed.
Sore arm within several hours; Severe nausea; Moderate chills; Moderate body aches; Moderate headache; Exhaustion; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153), via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on an unknown date in Mar2021 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 19:00, the patient experienced sore arm within several hours, severe nausea, moderate chills, moderate body aches, moderate headache and exhaustion. On 10Apr2021 at 17:00, 8 hours after vaccination, the patient experienced fever. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events sore arm, severe nausea, moderate chills, moderate body aches, moderate headache, exhaustion and fever were not resolved at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Evening of injection, feet swelled.  Resolved by next day, 3 days later urticarial/angioedema swelling hand, wrists, antecubital waist.  No itching, no fever.
Slight headache; Pressure headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-years-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 09Dec2021 11:00 (Lot number: 33030BD) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 Immunization; Covid-19 vaccine (Dose 2), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Slight headache"; HEAD DISCOMFORT (non-serious) with onset Dec2021, outcome "not recovered", described as "Pressure headache". Therapeutic measures were taken as a result of headache, head discomfort.  Additional Information: It was reported that consumer went yesterday morning at 11:00 to get her PFIZER BOOSTER shot and everything was fine and then later on that night, she started getting a slight headache but then it went away and she went to bed and woke up with slight headache again. So, she took some IBUPROFEN and went back to bed and when woke up had a pressure headache and it was been like this all day long. When probed if consumer wanted to report this or have some medical query too, she stated that need to know if there was something she needs to do or was she supposed to be worried about it or mean if it was going to go away. About weight she stated her weight, she did not know how much she weighed. About anatomical site and route of administration, she  stated, "You mean where I went in to get my PFIZER shot. Oh, it was kind of difficult to understand you, it was on my left shoulder. When probed for prior family medical history of same adverse event, she stated does anybody in my family have problem with like high blood pressure, yes actually her fiancé, he had his shot yesterday and he had the same symptoms as me. About treatment she stated that she used some Ibuprofen, dose used was 600mg.  No follow-up attempts are possible. No further information is expected.
Body aches; Sore arm; Under arm pain; Fatigue; This is a spontaneous report received from contactable reporter (Physician).  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 at 16:15 as dose 6 (booster), single (Lot number: HF9275) at the age of 49 years intramuscular, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Uterine fibroids" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 5 (booster), single; manufacturer unknown), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 02Oct2023, outcome "recovering", described as "Body aches"; FATIGUE (non-serious) with onset 02Oct2023, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 02Oct2023, outcome "recovering", described as "Sore arm"; AXILLARY PAIN (non-serious) with onset 02Oct2023, outcome "recovering", described as "Under arm pain". Therapeutic measures were not taken as a result of pain, pain in extremity, axillary pain, fatigue. Additional information: The patient had no other vaccines in four weeks. She had no COVID prior to vaccination or was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.