chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial fever, chills and headache for approximately 5 days.   Symptoms reduced with over the counter ibuprofen.   After the first week, strong adverse symptoms subsided, but cloudy/fuzzy headed persisted, in addition to elevated heart rate and chronic headaches.   I do not feel safe operating aircraft or  machinery.  Accordingly, I have taken extensive leave from my job over the past month to mask my diminished capabilities.  I am told that these symptoms are not unusual and have been attempting to wait it out.   One month after my second Moderna vaccine, I am becoming concerned over the lingering effects that may cost me my  22 year career.
By May 3 onset of fatigue, generalized aching in all muscles, soreness in shoulders, wrists, fingers, back, knees. By week of May 10 felt as though I had the flu. Saw rheumatologist on May 14 who drew labs and prescribed Prednisone for diagnosis of Polymyalgia Rheumatica
This spontaneous report as received from a registered nurse refers to a 58 year old female patient. The patient's concurrent conditions and medical history were not reported. On 26-OCT-2015 at 04:15PM, the patient was vaccinated with ZOSTAVAX after temperature excursion (lot # L012475, left arm, subcutaneous, dose 1). No adverse event was reported in the patient after receiving viable ZOSTAVAX after a temperature excursion on 22-SEP-2015. This is one of several reports received from the same reporter (ZOSTAVAX was given between 22-SEP-2015 to 09-NOV-2015 after temperature excursion). Additional information is not expected as follow up already received (this was received as a follow up for the related master case).
congestive heart failure; other zoster related injuries; shingles; Information has been received from a lawyer and an elderly patient of unknown gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions in a pharmacy. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a healthcare facility for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: congestive heart failure, shingles, and other zoster related injuries. The outcome of the events were unknown. The causality assessment was considered as related by the lawyer.  Upon internal review, congestive heart failure was determined to be medically significant.
Patient's wife brought him to get third shot because she feels he is immunocompromised due to his age.  They were informed patient was getting a Moderna shot and patient/wife signed the waiver.  After he was given the shot, the nurse was given the COVID vaccine card and saw his previous two shots were Pfizer shots.  The couple was told he has now received a Moderna shot and to notify the office if he does poorly.
Arm swelled up at injection site. Flu like symptoms for next few days. Eventually would up being taken by ambulance to ER with suffering from dizziness, vomiting, sever diaphoresis.  Found to have sudden onset vertigo and severe dehydration. Still feeling some mild flu like symptoms?.but do not have the flu.
Erythematous papulo-macular rash on face, arms, body, legs and eye swelling. Given 0.1cc (1:1000) epi SC. Benadryl 10mg per mouth. Home with Benadryl every 4-6 hours, prednisolone 18mg every day for 3 days.  Nurse follow up on 11/01/04 states: "Irritable, allergic reaction."
Information has been received from a physician concerning a child who a while ago, was vaccinated with an oral first dose of Rotavirus vaccine. One month later, the pt was admitted to the hospital with Rotavirus and dehydration. It was reported that the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
pt received a Moderna booster  as the 4th dose. the first 3 doses were Pfizer. - pt claims she feels sick and her GFR has decreased. she also says she has a full body rash and is taking benadryl for it. that provide little relief. I advised  her to seek medical attention form a physician.
She now has something slipped up into her heart and she would've been dead if she wasnt taken in; This is a spontaneous report from a contactable consumer. This consumer reported for a 99-year-old female patient (aunt). A 99-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated, she wants to thank you for your vaccine, it was most likely that, that got her 99-year-old aunt, she would've died in her sleep anyway at 104. No cane, no walker. Full head of hair. Probably born in . Something slipped up the heart now. They were the responsibility party. She now has something slipped up into her heart and she would've been dead if she was not taken in. The healthiest people like her aunt (patient), she took one of them vaccines and now she has something slipped up her heart (on an unspecified date). The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
swollen neck; swollen mouth; swollen face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen neck), MOUTH SWELLING (swollen mouth) and SWELLING FACE (swollen face) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concomitant products included LISINOPRIL, METOPROLOL and EPINEPHRINE (EPIPEN) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced SWELLING (swollen neck), MOUTH SWELLING (swollen mouth) and SWELLING FACE (swollen face). At the time of the report, SWELLING (swollen neck), MOUTH SWELLING (swollen mouth) and SWELLING FACE (swollen face) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information reported by the reporter  It was reported that the patient was kept on going with words like her epipen was costing a lot and she wanted information on reimbursement. She also mentioned something about surgery. Did not clarify what kind of surgery but said something like she was not sure if surgery was because of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non-significant follow up appended On 04-Aug-2021: Significant follow up. Narrative details updated. Concomitant medication was added. Procedure was added.
VAX Clinic hostal outside/Recovery as well.  temp 84 degrees - 1248 client c/o "not feeling well and hot". Denies other complaints such as Respiratory issues, chest pain, abdomen pain, no nausea/vomiting. denies throat itchy, no tongue swelling/itchy. Client rested outside then moved to indoors to recover w/MD and staff VS obtained throughout, hydration of water provided w/snacks. 1:28pm While resting in sitting position, client c/o dizziness which lasted less than 5 minutes. Client continues to deny trouble breathing/respiratory involvement such as tongue swelling, no tongue itching, or chest pain, no headaches, no tingling.  1:35p Client stats that she feels better and back to self. Client observed until 2pm. MD walked client to car @ 2pm, NAD, made aware to call emergency services w/concerns and follow up w/PMD emer and as needed.
PATIENT DEVELOPED AN ABCESS AT THE INJECTION SITE  AFTER RECEIVING THE VACCINE, AND IT SEEMED TO BE GETTING BETTER. HOWEVER, LATER IT "SWELLED UP LIKE AN APPLE." PATIENT THEN WENT TO THE EMERGENCY DEPARTMENT ON APRIL 1, 2021 AND WAS TREATED WITH ANTIBIOTICS. PATIENT RECEIVED PRESCRIPTIONS FOR CEPHALEXIN 500MG AND BACTRIM 800-160MG. EXACT TIME COURSE OF START OF SYMPTOMS IS UNKNOWN.
had a stroke; Right-sided paralysis; Unable to close right eye; Soreness; headache; Extreamly painful ear; Tiredness; Inability to eat; Slurred speech; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th September 2019, 5 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant and clinically significant/intervention required), paralysis (serious criteria GSK medically significant and clinically significant/intervention required), lagophthalmos (serious criteria clinically significant/intervention required), pain (serious criteria clinically significant/intervention required), headache (serious criteria clinically significant/intervention required), ear pain (serious criteria clinically significant/intervention required), tiredness (serious criteria clinically significant/intervention required), unable to eat (serious criteria clinically significant/intervention required) and slurred speech (serious criteria clinically significant/intervention required). The patient was treated with prednisone. On an unknown date, the outcome of the stroke, paralysis, lagophthalmos, pain, headache, ear pain, tiredness, unable to eat and slurred speech were not recovered/not resolved.   It was unknown if the reporter considered the stroke, paralysis, lagophthalmos, pain, headache, ear pain, tiredness, unable to eat and slurred speech to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. On the following Saturday morning, she woke up with right-sided paralysis, unable to close right eye, soreness, headache, extremely painful ear, tiredness, inability to eat and slurred speech. The patient had to be seen in the emergency room (ER) and was put on prednisone which she wals still taking. The patient reported that she looks like she had a stroke. All of these symptoms have gotten worse and are not improving.   The patient asked what she could do to improve her symptoms medically and advised her to consult with her MD concerning any type of medical advice.
The next morning I felt a little fatigued and had a sore throat which continued until Tuesday. Tuesday the sore throat became very bad and I was coughing all though the night. Wednesday morning I went into work and ended up leaving to see my doctor due to shortness of breath, wheezing, dizziness, and extreme sore throat. I was tested for COVID and step which were both negative. I was started on Albuterol inhaler, oral steroids, and cough medication that day. The following day (9/16) I felt a little better but by that night everything was back again. Friday the 17th I was seen the the ER due to shortness of breath becoming worse and elevated HR. I was put through a series of test and tested again for COVID all coming back negative. I was treated with Doxycycline and told to follow up with PCP. By Monday I was still feeling unwell with no improvement.  I went back to the doctor and was started on a long term inhaler Fluticasone-Salmeterol and instructed there was nothing else they could do for me at the office and if worsening to go to the ER. I have made some improvement over the last few days but still having shortness of breath with small activities and coughing with wheezing.
Dizzy, fever, chills, aches, complete exhaustion, slept for 2 days - could not get out of bed, no appetite
Pt states she is starting to form hives on her hands and arms. Pt states she took her own Benadryl 10 mins prior to notifying EMS. Pt denies any swelling, difficulty swallowing, and difficulty breathing. Pt is stable. Pt was referred to a high risk clinic. Pt states the hives are going away and she is feeling better. Pt didn?t require transport to hospital.
Fever, body aches, strong pain in injection arm a few hours after injection.  Herpes Zoster (shingles) outbreak covering the full injection arm and shoulder with strong pain (especially around arm joints) starting the day after injection (10/6).  Visited the emergency room at 4:30 am on 10/8 due to worsening symptoms. Prescribed methylprednisolone 4 MG Tablets (6 tablets first day and decrease by 1 tablet each day for 6 days) and Valacyclovir HCL 1000 MG Tablets (3 tablets a day for 7 days).  Continues to have rash and strong pain in arm and shoulder as of today (10/9).
Red, raised and sore area about 3"x 3" at injection site (this was still two weeks after injection)
03-26-03 pt. c/o reddness to right eye. He stated saw Dr. at Hospital/ER Dr. and DX with Conjunctivitis and a prescription was ordered. Pt. continued to have symptoms to the right eye and was referred to see Dr. /Infectious Disease Specialist for 2nd opinion.  Dr. stated pt had conjunctivitis to the right eye and this condition had nothing to do with the smallpox vaccine.
52 years old female patient who received an expired dose of fluzone quadrivalent with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 52 years old female patient who received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 17-Oct-2022, the patient received expired dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AA) (expired product administered) (latency same day) (dose, formulation, strength, and expiry date: unknown) via intramuscular route in unknown administration site for flu (influenza).  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown   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 the 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.
lt arm swollen red to touch, back muscle spasms, little chest pains w/SOB noted later in evening p/vax;
After receiving the vaccine, it seemed as if I had a curtain come down over my right eye in a diagonal way. I had blindness that covered a third of my vison in the upper right corner. I didn't think anything of it at first, but then it happened a third time so I thought that was odd. I called my eye doctor the last time it happened. I thought it was a detached retina. I went to the doctor the next day but he couldn't find any signs of a detached retina. He was concerned I had a TIA. He wants me to have a doppler of carotid arteries in my neck. I had an appointment with an ophthalmologist on May 25th. My appointment for the doppler was on June 1st. On June 3rd, I went to my family doctorand he looked at results of the test. He was concerned about temporary blindness but doesn't know the cause of it. He wants me to see a neurologist. On June 30th I had an appointment with the neurologist and he said he didn't think it was a TIA. Nothing has been found or discovered as to why I am experiencing the temporary blindness. As of May 24th, that was the last incident I had with temporary blindness, and I haven't had it since.
fever; body aches/hurting too bad to stay in bed; arm red; swollen arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2019, the patient received the 2nd dose of Shingrix. In December 2019, 1 day 14 hrs after receiving Shingrix and an unknown time after starting Acetaminophen and ibuprofen, the patient experienced fever, general body pain, erythema of extremities and swelling arm. The patient was treated with paracetamol (Acetaminophen) and ibuprofen. On an unknown date, the outcome of the fever, general body pain, erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the fever, general body pain, erythema of extremities and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received shingrix vaccine around 1 PM on Saturday of this past week and awoke around 3 AM the following morning with a 103 degree temperature and multiple body aches.  The patient was hurting too bad to stay in bed. Since that time, the patient was rotating acetaminophen with ibuprofen to try to keep the fever down. The patient arm was red and swollen.  The patient asked was all trying to kill me. What was the death all from this shingrix vaccine. The reporter asked what to stop all this.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 5-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2021 at 13:00 as dose number unknown . single (Lot number: 331308A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for pre-renal acute kidney injury, carcinoma, secondary malignant neoplasm of liver, obstructive jaundice, T2DM, HTN, anemia, ocular hypertension, morbid obesity, sleep apnea. Pt presented to ER 3/4 with chief complaint of c/o abdominal pain and bloating with urine that is yellowish red, getting darker, x 2 weeks". Was found to have a new liver mass with biliary duct dilation. Had biliary stent placed but was readmitted with worsening jaundice. Discharged with discussion for hospice placement. Deceased 4/10/2021 with no cause of death noted.
Circular, palpable papule. Slightly red in color. Patient states that it does itch. Located just on right arm and lower back. Started about 1 1/2 after injection. Papules on right arm are starting to disappear. Advised patient to call OB/GYN. Advised her to take BENADRYL. Denies any trouble breathing at any time or at present time.
rash on her neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her neck) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced RASH (rash on her neck). At the time of the report, RASH (rash on her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient reported that she did not use any medication as treatment.
Chest pain developed on 11/27/2021. Tested positive for Covid on 11/28/21. Chest pain became severe on 11/29/21 so went to the local Emergency Department. O2 sats on RA 87%. Was admitted to the hospital with a dx of bilateral pleural effusions and a PERICARDIAL EFFUSION with COVID-19. No prior cardiac history; no other pertinent medical history.   Question #21 included here due to form not accepting input: Was admitted for 3 days at hospital.
Hugh heart rate and chest pain. Heart rate over 170; Hugh heart rate and chest pain. Heart rate over 170; This is a spontaneous report from a contactable consumer (patient). A 20-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number: EN6208, Expiration Date was not reported), via an unspecified route of administration. administered in left arm on 18Mar2021 12:00 (at the age of 20-years-old) as dose 1, single for covid-19 immunisation at hospital and Other vaccine unknown dose number via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EW0177) as dose number Unknown, single immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. No other vaccine received in four weeks. Any other medications the patient received within 2 weeks of vaccination included Luvox, Lamical. It was reported that, on 27Mar2021 7-10 days after 1st dose, the patient experienced Hugh heart rate and chest pain. Heart rate over 170. The patient underwent lab tests and procedures which included heart rate increased: 170 on 27Mar2021. Metropol was prescribed as treatment for the adverse event. The patient visited emergency room and physician office due to events. Therapeutic measures were taken as a result of hugh heart rate and chest pain. heart rate over 170. The reporter assessed the seriousness as non-serious. The outcome of the events was reported as recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.