chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed nasal congestion, sneezing, cough, and headache on 2/21/2023. I tested myself for COVID-19 that morning, and the result was negative. On 2/22/2023, I still had the symptoms, only a little worse. I tested again and got a positive result. On 2/23/2023, my symptoms were worse, and I began taking Paxlovid. The symptoms began to improve, but they persisted until 2/26/2023, which was also the day that I returned to work. On 2/25/2023, I took another test and got a negative result. I took the test two more times for a couple of days subsequent to that, and the results were negative. At the time of this writing, I have a lingering cough. I also sometimes get nauseous and have to lie down. However, I have resumed some of my activities, such as cycling and yoga.
Big reaction; Bottom of arm gets inflamed; This case was reported by a pharmacist via call center representative and described the occurrence of nonspecific reaction in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced nonspecific reaction and swelling arm. On an unknown date, the outcome of the nonspecific reaction and swelling arm were unknown.   It was unknown if the reporter considered the nonspecific reaction and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that she had people with a big reaction and the whole bottom of their arm got inflamed. The reporter consented to follow up. The reporter granted permission to follow up but declined to provide a mailing address. The pharmacist was not at work at the time of this call and no further details were provided.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze & Rash Narrative:  Other Relevant History:
This spontaneous report as received from a certified medical assistant refers to a 12 month old patient of unknown gender. No information on their pertinent medical history, drug allergies and reactions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported). On the same unknown date, the patient was also vaccinated with a dose of PROQUAD (dose, route of administration, lot# and expiration date were not reported_. No adverse effect was reported. Additional information has been requested.
17 days after J&J shot, had massive stroke.  Taken to Clinic for emergency brain clot removal.  Critical condition for a week with lots of testing searching for cause of "UNPROVOKED" clot developed in right leg and progressing to brain.  NO health issues or meds of any kind prior to event.  Still after7 months of very slow moderate recovery, still no know cause of clot development.  Now on blood thinner and cholesterol; meds as well as blood pressure and anxiety meds.  Prior to 4/28/21 NO meds.  Clinic has tons of medical records and testing and test results, too many to include here.  Just wanted to report the event that we think was clearly caused by the J&J Covid 19 vaccination on April 11, 2021.
After screening patient for vaccine eligiblity, RN Vaccinator attempted to give 0.3 ML of COVID-19 Pfizer vaccine in patient L arm.  When giving this initial injection the Vantage point needle/syringe failed as when needle was pulled from the patient, more than half of the vaccine was leaking from syringe.   RN vaccinator alerted RN/Clinical Manager who consulted with Pharm D , regarding the situation.  Per protocol, it was advised that client should be revaccinated.  Client informed of situation and reccomendation for re-vaccination and agreed to get re-vaccinated with 03.ml of Pfizer Covid-19 . 2nd Dose was administered without any problems.  Ct. reported no side effects.
Tenderness to (L) arm near site redness and swelling 80cm x 110cm approximately 40cm distal to injection site. Temp 97.6. Receives TYLENOL 1000mg TID. Warm moist heat applied x3 days.
tinnitus after second dose that became worse after booster dose; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 13Jan2022 (Lot number: FJ3586) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (ongoing), notes: diagnosed about 10 years ago. Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis (ongoing). Vaccination history included: Bnt162b2 (DOSE: 1, Lot: EK9231, Expiration: unknown), administration date: 07Jan2021, when the patient was 53 years old, for Covid-19 Immunization; Bnt162b2 (DOSE: 2, Lot: EL3249, Expiration: unknown), administration date: 28Jan2021, when the patient was 53 years old, for COVID-19 Immunization, reaction(s): "Tinnitus", "like the ringing is causing pain"; Bnt162b2 (DOSE: 2, Lot: EL3249, Expiration: unknown), administration date: 28Jan2021, when the patient was 53 years old, for COVID-19 immunization, reaction(s): "she could not sleep". The following information was reported: TINNITUS (non-serious) with onset 13Jan2022, outcome "not recovered", described as "tinnitus after second dose that became worse after booster dose". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of tinnitus.  Additional information: The tinnitus was ten times worse within a day of getting the booster. She can still hear the ringing even if she has the TV on. She could not sleep since it was so loud. She sat on the couch till 23:30 and then finally went to bed since she was so tired. She gets up super early. It is super loud today, she has to get the ball in motion. The patient did not receive any other vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Pain in left arm approximately 3 hours after injection.  Chills began  the night of getting vaccine. Fever set on shortly after and lasted until approximately 7pm the next day. Headache set in approximately midnight  and continued to varying severity until Sunday (2 days after injection) morning around 10 am.
No additional adverse effect reported; on 2/21/2020 patient received a dose of improperly stored ROTATEQ; Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 21-FEB-2020, the patient received a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660112 and expiration date 18-OCT-2020; strength and dose detail were unknown) orally for prophylaxis. The vaccine was exposed to temperature excursion below 2 degrees Celsius (1.28 degrees Celsius) for 2 hours and 30 hours (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effect were reported.
Pt recvd 1 dose of Engerix-B on 12JUN91 & 12JUL91 for vax against Hep B; 2 wks p/2nd dose pt exp anorexia, dark urine, epigastric pain & jaundice; Pt referred to MD & is under a MD care;
Chills; Feels sluggish; Body aches; Fever 99.4 F; Feels cold; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), SLUGGISHNESS (Feels sluggish), MYALGIA (Body aches), PYREXIA (Fever 99.4 F) and FEELING COLD (Feels cold) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (Chills), SLUGGISHNESS (Feels sluggish), MYALGIA (Body aches), PYREXIA (Fever 99.4 F) and FEELING COLD (Feels cold). At the time of the report, CHILLS (Chills), SLUGGISHNESS (Feels sluggish), MYALGIA (Body aches), PYREXIA (Fever 99.4 F) and FEELING COLD (Feels cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was provided by the reporter. No concomitant medication information was provided by the reporter.
pt given 4 vaccine shots on 1/29/2010, after last vaccine hpv pt. became very pale unresponsive with petit mild seizure, applied cold compresses to face neck and forehead, at which time pt responded, was alert and was given sips of ginger ale, then she was allowed to lie down on exam table for 20-30 minutes, was later discharge home with father.
mild nausea; fatigue; This is a spontaneous report received from a non-contactable reporter (Other HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 09:00 (Lot number: EW0217) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Raynaud's syndrome" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication included: IRON; PROBIOTICS; PREBIOTICS NOS. Past drug history included: Amoxicillin, reaction: "Known Allergies: Amoxicillin".  The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "mild nausea"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue".  Additional Information: The first dose of bnt162b2 was received by the patient at exactly 09:00 on May2021 at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination including multivitamins, iron, pre/probiotics. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101260777 Same reporter, patient, and product; Different dose and events
Began having tingling in peripheral extremities and brain fog 30 minutes after injection which subsided after an hour. Experienced exhaustion, mental fog, mild arm soreness first night which continued and increased with nausea through hospital visit on 8/23/2021. Began having chest pressure/discomfort and left arm numbness at noon on 8/23/2021 then headache began. Took my vitals at home as follows: 172/106, 142 bpm and afebrile 95% on room air. Took 324 aspirin and rested supine for 45 minutes and drank water- symptoms did not subside. Went to hospital after being evaluated by critical care nurse friend in my home as all symptoms were still present and vitals were still abnormal as they were prior to her arrival. EKG, troponin, dimer, chest X-ray performed. Cardiac enzymes were normal. 3L of fluids administered by EMS and hospital. After fluids ALL symptoms subsided and was discharged with CP diagnosis. I do not have medical history of HTN- BP is normally 120s/70s. My fluid intake and activity had not changed and had not been outside in heat. The only thing that was a change in my life was the Moderna shot on 8/21/2021.
This spontaneous report was received from  a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K011562, expiration date 08-APR-2017; exact doses and route of administration were not reported). No adverse effects were reported. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Sep2023 to 07Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298348 Same reporter/patient, different drug/AE.;
Arm burning and swelling. Hives. Returned to office where monitored and Benadryl administered. Ice pack helped swelling subside.  Was given doctor contact info if problems occur later. Physician called later in the evening. Feeling better. Swelling slowly subsiding.
Patient wash flushed reported blurred  vision and lost balance and dropped to the floor. Did not lose conciousness. Lay down for less than  minute and sat up. Was flushed and sweating. EMS contacted at initial observation of incident. Pulse measure at 78 bpm. EMS arrived. Patient was sitting and thirsty. EMS monitored patient. Patient declined to go to ER or further.
Redness developed on arms and chest within 10 min of injection and increased as I waited the 30 minutes (since I have a history of allergies-although not to immunizations). Pharmacist saw and said I was "sensitive" and could use icepacks and take Benadryl to which I mentioned I was already taking and he said to take more.  On the way home, I got large hives (without itching) on my arms.  I took more Benadryl throughout the night and the next morning, I had some redness for the next couple of days but no more hives.  I took more Benadryl and felt fine.  First Covid vaccine seemed to exacerbate my autoimmune conditions, so hives are gone but idk if I'm out of the woods yet.
Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 22-Nov-2021; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 22-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 22-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 22-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that dose were stored in the freezer before administration. One dose was administered on 22-Nov-2021. No treatment information was provided.
Received Moderna Covid vaccine at outside facility (walmart) 4/25/2021, 5/24/2021.  tested COVID positive 8/11/2021. vaccine failure.
Fever, chills, muscle ache, tired, headache, swollen arm pit, bruising at injection site
Unexplained pain in joints and tendons with swelling and redness over a period of 3-4 weeks.  Treated with prednisone 10 mg for one month and then withdrawn gradually.  No firm diagnosis, possible polymyalgia rheumatica or gout or pseudo gout.
RespDepression, CoughWheeze & Syncope Narrative: Patient started having shortness of breath about 20 minutes after injection. First reported as a cough then asked for water and was having difficulty breathing.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-MAR-2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
No additional AE; Nurse calling to report that a dose of PNEUMOVAX23(pfs) with a labeled expiry of 10/15/2022 was administered to a patient on 10/25/2022.; This spontaneous report has been received from a nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 25-OCT-2022, the patient was vaccinated with a labeled expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliter (ml) (strength, route of administration and vaccination scheme frequency were not provided; lot number U003306 that was verified to be a valid lot number with an expiration date reported as and established as 15-OCT-2022) (expired product administered) for prophylaxis.  By the reporting time, the caller confirmed that she was not know if a temperature excursion was involved.   No additional adverse event (AE) was reported (no adverse event).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 04-JAN-2008, a healthcare provider at a public healthcare department, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 24-AUG-2016, the patient was treated by an optometrist (O.D.) at an eye clinic for shingles. The patient was diagnosed with shingles and or other zoster-related injuries (Not further specified) after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, 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 (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
weight loss; loss of taste; loss of taste and smell; This is a spontaneous report from a contactable consumer reporting on behalf of the patients. This consumer reported same events under the same suspect product for two patients. This is one of 2 reports.   A female patient of unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced weight loss and loss of taste and smell on unspecified dates, but the COVID-19 test result was negative on unspecified date. All of the symptoms were escalating and getting worse. The patient has not yet recovered from the events. The events were assessed as serious (life-threatening condition).   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383020 same reporter, product, event; different patient
INCREASE IN TEMPERATURE 2HR AFTER VACCINE ADMINISTERED. TEMP 100F AS OF 1100. PT WAS ADVISED TO GO TO ER IF SYMPTOMS WORSEN OR PERSIST. PT DIRECTED TO CALL CLINIC IN THE MORNING WITH AN UPDATE
patient developed a fever right after injection, went up to 103.5 overnight, called off work the following day sick - headache and vomiting
In January I started having this rash on my cheeks, jaw, and neck. I called my dermatologist and was able to be seen. The rash began to move down my arms and onto chest. This rash comes and goes but it does get worse when I am outside. It starts at my face first. i do have a steroid cream that can help calm it down after a few weeks. When the rash reaches my arms and chest it gets itchy. I was at the doctor today and they gave me the biopsy results and stated it is a Drug Eruption Response.
Information was received from a female consumer who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck) in the back of her arm.  Subsequently the patient developed injection site pain, redness and a lump.  No further information was provided.  There was no product quality complaint involved.  No further information is available.
Redness, warmth, swelling size of quarter, red raised bumps no fluid filled to sight of injection. " few red raised bumps to chest not fluid filled".   Reported 10/20/2022 at 4:29 No difficulty breathing, chest tightness, or throat tightness. Benadryl given.   10/21/2022 09:25- updated call that pt now has hives all over his body, has been giving benadryl 25 mg every 4 hours over night. no difficulty breathing, or throat difficulties. md instructed to give benadryl 50 mg every 6-8 hours, start zyrtec 10 mg daily.  No further calls from family after this call. Issues resolved.