chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UTI; A spontaneous report was received from a consumer for a 42 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an urinary tract infection (UTI).  The patient's medical included diabetes. No concomitant product use was reported.  On 13-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 10-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 06-Feb-2021,  the patient experienced symptoms consistent with an urinary tract infection. Treatment for the UTI  included Levofloxacin and Fluconazole.  There was no change planned to the dosing schedule of mRNA-1273 in response to the event  The outcome of the event, urinary tract infection was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Patient declined further contact. No further follow-up information is expected.
armpit is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "armpit is swollen". The event "armpit is swollen" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that, Ever since, she feel like her armpit is swollen and is slightly bothersome. She have had a mammogram, three breast exams, and an ultrasound. None of which show any abnormalities. If she take Ibuprofen, the feeling in her armpit goes away. She was wondering...Is it possible that she w is still having a slight reaction from the vaccines even though it has been 5 months since booster. The doctor stated her lymph node was not swollen.  The lot/batch number Is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
pt recv vax & devel severe h/a, fever & chills & nausea the day following vax;h/a persisted until 24OCT96;
No additional adverse event; Administered an expired dose of Rotateq; This spontaneous report as received from a consumer (office manager) refers to a 6 month old patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided.  On 15-DEC-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Lot No. 1691302 has been verified to be a valid lot number for [Rotavirus Vaccine, Live, Oral, Pentavalent], expiration date reported as 12-DEC-2021, but upon internal validation established as 23-JAN-2022), orally as prophylaxis (anatomical location was not provided) (expired product administered).  No additional adverse event reported.
Extreme loss of energy for the better part of three days.  Way more than the "tiredness" described in the literature.  Lots of pain and swelling in the left arm directly below the injection point.  Severe enough to contact nurse for further guidance.
pt in house  Date of Admission: 7/28/2023   Medical Diagnosis: Bipolar 1 Disorder   Date of Surgery/Procedure: not applicable this admission    Precautions: Fall risk, right hemi-paresis, impulsive at times,   Per MD note 8/5 "COVID-found to be positive; asymptomatic; completed paxlovid here; isolation already complete for community at 5 days" - isolation precautions lifted at bedside.    PPE Worn:  Provider: N95 Patient masked? No   Covid-19 Testing:  Lab Results
Two to five minutes following vaccination, patient's significant other reported to pharmacist he was not feeling well. Pharmacist immediately went to patient to find him unconscious on the floor. Patient was having no trouble breathing. Could not get reading of blood pressure or pulse. Patient was in and out of consciousness and very determined to stand back up despite wavering consciousness. Patient was monitored and kept in a safe location until EMS could arrive. Patient was loaded onto stretcher and taken out of the store by EMS. It is unknown if the patient left with EMS to the Emergency Room.
Information regarding Prevnar was received from a Pediatrician regarding a 2-month-old male patient who received a first dose on 21-May-2007. On 31-May-2007, the patient was hospitalized with pneumococcal meningitis, pneumococcal bacteremia and brain abscesses. On 31-MAY-2007, the patient was hospitalized with pneumococcal meningitis and pneumococcal bacteremia. On 01-Jun-2007, a spinal and blood culture were performed which revealed streptococcus pneumoniae, serotype not reported. During the patient's hospitalization (Jun-2007), the reporter noted that as a result of meningitis the patient experienced several convulsions and also developed brain abscesses. Due to the location in the brain, the abscesses were not cultured. Treatment included intravenous vancomycin and Rocephin. On 02-Jul- 2007, the patient's condition was improved and he was discharged to home to continue intravenous antibiotics. On 08-Jul-2007, the child developed a fever (temperature not specified), an was re-admitted to the hospital. As of 09-Jul-2007, the patient remained hospitalized, his outcome was not available. CSF results (results: streptococcus pneumoniae, serotype unknown) and blood culture (results: streptococcus pneumoniae, serotype unknown) were done on 01-Jun-2007. No additional information was available at the time of this report.
New acute onset hydrocele presenting with (L) scrotal swelling on 8-24-16 seen in ED with subsequent ultrasound on 8-25 and visit 8-26.
During Covid-19 facility audit it was brought to our attention this individual was not of the recommended age to receive this vaccine.
Started with coughing, about 4 hours after the vaccination, then chills and fever, I visited the ER about 31 hours after the shot. They gave me an IV to reduce my fever. I slept well the second night , other than my muscles ache. Then on Friday morning which was about 47 hours after the vaccination, I had a seizure.
Caller reported that he received the first dose of the pfizer vaccine on 21Jan2021 and the vaccine felt like water going through his muscles.; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history was muscle relaxer and arthritis and concomitant medications METHOCARBAMOL muscle relaxer and acetylsalicylic acid (ASPIRIN) a bayer aspirin for arthritis. On an unspecified date, the patient experienced caller reported that he received the first dose of the pfizer vaccine on 21Jan2021 and the vaccine felt like water going through his muscles. Caller reported that he received the first dose of the pfizer vaccine on 21Jan2021 and the vaccine felt like water going through his muscles. Caller stated that he takes methocarbamol and bayer aspirin and wanted to know if this caused this sensation. He was concerned since he took a low dose baby aspirin. He was asking if that was considered a blood thinner. He took the first shot three weeks ago. He was supposed to get the second dose this week. For his own piece of mind, he would just want to ask the question. He had the vaccine at his primary doctors office. He was curious about the comment on page 2 of the handout. It said to tell the vaccinator about all of your medical conditions. The outcome for event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Child felt fine after his vaccinations but had syncopal episode while driving home approximately 10 minutes after vaccinations.
sore muscle; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Lot number: EP6955) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Tussinex allergy" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; MIRENA. Past drug history included: Aspirin, reaction(s): "allergies". The following information was reported: MYALGIA (non-serious) with onset 23Mar2021, outcome "not recovered", described as "sore muscle"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "not recovered", described as "sore arm". Therapeutic measures were not taken as a result of myalgia, pain in extremity. Additional information: The most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
I started feeling funny not long after the shot. I had some pain that was in my eyebrow area. I was so exhausted that I started crying. My legs and arms were very heavy and it was hard to move them. Then, in my left hand going up all the way to my shoulder, starting with my fingers, they went numb going all the way up to my shoulder. It tingled so bad that it hurt. Then, it started in my legs.
45 minutes after the shot, left eye swelled both the eye lid and under the eye. Benadryl was given and the swelling stayed, but did not get worse. Emergency doctor number was called. 12 hours after shot, fever of 102, tiredness, eye still swollen, cough, throat hurt, and overall achiness which lasted for 4 days. The eye swelling lasted for 39 hours. Tylenol and Benadryl were given over the course of illness as directed by doctors.
We received the vaccine on 05/16/23, so the beyond use date was 06/15/23. I noticed it later when I was going through all my expired meds for the month. We administered the vaccine about 14 hours after the BUD. I notified Moderna (case number NA23-00033152) and the patient. There were no temperature excursions prior to vaccination. I spoke with the patient and she said she had typical adverse effects, such as fever and chills. She declined any further vaccination (if Moderna deems it necessary) since she feels like she received appropriate protection due to having typical side effects from the vaccine.
A legal complaint was received from an attorney regarding an adult male. The plaintiff's history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, "sometime between 1962 and 1963, plaintiff was administered OPV or IPV." In May 2000, the plaintiff was reportedly diagnosed with lung cancer. The legal complaint states that the "contaminated vaccine products were toxic and carcinogenic" and that the "plaintiff's exposure to asbestos, asbestos-containing products, and SV40 virus caused severe and permanent injury to the plaintiff, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage." On 8/26/02, he died from lung cancer.
3:55 vaccine administered 4:05 rash on arms- clusters of pinpoint dots. notified staff- diphenhydramine 50 mg given 4:05-4:30 rash spread to chest, neck. face flushed. throat "weird" swollen and lumpy. dizzy. No SOB.  EMS called and responded- evaluated BP 130/70, O2 98. Released for private transport to Hospital ED. 4:35-5:00 private transport and seen at ED.  5:03 Epi given IM right thigh. required to observe x4 hours Symptoms resolved and discharged ~9pm
Satellite lesions, Lymphangitis from site to regional nodes, Regional lymphadenopathy, Considerable local edema at the site, Intense erythema,running a fever of 101.4 avg., meds- Keflex,Benadryl around site for itching.
at 15 mins post injection started to get extremely hot from Right side to left. Then like half of my body was cut head to toe in half and the left side of my body went numb and tingly. I could barely move my extremeties. Tounge began to burn like a 9volt battery was being held on it. I was taken to the ER and was told I had a rash on my chest neck and chin. I was treated with Epi IM, Benedryl, famotdine, then had epi again because my tounge felt fat and like a 9volt battery again. Epi went IV second does and had extreme pain with that. Had IV tylenol . Along with IV fluids. For the next 5 days I have had pain in my right harm , shoulder , neck into my head to the tip of my nose. The first 4 days were so bad that I could barely move and would get nauseated and throw up if I moved just right. each day the pains in my right arm,shoulder, neck and head did get better by about 25 percent each day. You could feel it getting better with each day I woke up.  I was also having ear pain that seemed to be worse on 1/19/21. A PA checked my ears and said they were clear.Today, 1/22/21 is the first day I have been able to turn my head without being so sore and feeling nauseated. I was also very fatigued until today, 1/22/21. My hips and lower body are sore today and upper body seems to be less sore by 75%. I still am numb at times in my feet and fingers but can turn my head a lot better today.
Patient received his 2nd Shingrix vaccine on 12/8/21. 30 minutes to one hour after administration he experienced an adverse reaction. He was driving down the interstate and felt his heart rate decreasing, so he pounded on his chest. Following this sensation he had a syncopal episode that he believes to have lasted 3 to 5 seconds. He woke up and was still driving down the road. This did not occur again and he made it to where he was going. He reported other common sides effects in addition to this syncopal episodes. These were fever, chills, and malaise. Dr. reported this event to me the following day on 12/9/21.
On 01/07/2023, I attended a workshop and was exposed to an upper respiratory virus that started with muscle aches, sore throat, malaise. From there, I developed a major cough that lasted three or four weeks. I did go on a round of antibiotics for treatment. In early February, I visited my granddaughter and caught another upper respiratory virus with similar symptoms that also last three or four weeks. I have now, just recovered from a third upper respiratory virus that also required antibiotics. All three viruses have had very difficult, long-lasting coughs with heavy mucus and abdominal pain. It's just unusual for me to have these many viruses so close together and so similar. It has caused me to think that I may have long COVID-19 or perhaps something has happened to my immune system.
Rapid heart rate, arrhythmia felt at 7pm 12/30, still present in morning 12/31/20, at 7:00 am was found to be in afib on monitor at work (I am a surgeon).  Treated in emergency room after EKG confirmed a-fib.  Received potassium and flecainide and converted to normal sinus rhythm after several hours.
This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 2-6 month old patient who was vaccinated with a first dose of Rotateq. Concomitant vaccines administered on that same day included "other vaccines". The patient subsequently became irritable. Unspecified medical attention was sought. The patient's symptoms subsequently resolved on their own after a short period of time. It was unknown if the patient completed the series.  This is one of several reports received from same source.  Additional information has been requested. Information has been received from a physician concerning a 55 day old male who on 19-DEC-2006 was vaccinated PO with the first dose of ROTATEQ (Lot # 655082/0779F). Concomitant vaccinations administered on that day included the first IM dose in the left thigh of PEDIARIX (Lot #AC21B073AA), the first IM dose in the right thigh of ACTHIB (Lot # UE994AA) and the first IM dose in the right thigh of PREVNAR (Lot #B08646P). The physician reported that on 19-DEC-2006, the patient became irritable and had prolonged high-ptiched crying for several hours post-vaccination. Unspecified medical attention was sought. The patient's symptoms subsequently resolved on their won after a short period of time. On 27-FEB-2007 the patient was vaccinated PO with the second dose ROTATEQ (Lot #656188/1238F). Concomitant vaccinations administered on that same day included teh second IM dose in the left thigh PEDIARIX (Lot #C2569AA), the second IM dose in the right thigh ofACTHIB (Lot #UF929AA), the second IM dose in the right thigh of PREVNAR (Lot #B08684C) and the second IM dose in the left thigh of IPOL (Vero) (Lot #Z0324). The physician reported that on 27-FEB-2007, patient became irritable and had prolonged high-pitched crying for several hours post-vaccination. Unspecified medical attention was sought. The patient;s symtoms subsequently resolved on their own after a short period of time. It was unknown if the patient completed the series of ROTATEQ. This is one of several reports received from the same souce.Additional information is not expected.
1st dose in 2020, 2nd dose not yet received /Shingrix late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2020, 2nd dose not yet received /Shingrix late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAR-2023 A reporter reported that a patient did not receive another dose (2nd dose) of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient's brother works as a medical assistant and his brother, the patient, experienced numbness on his whole arm as opposed to the area around the shot when he went for his 2nd  Pfizer dose at clinic on June 14th around 3:15pm. They are looking at possible nerve damage to the arm. According to the patient's brother, the person administering the vaccine went in at an angle that is not 90 degrees and therefore did not administer the vaccine correctly and caused injury to the person they vaccinated.
Body aches, chills, headache, stinging eyes, nausea, vomiting, loss of appetite, fatigue. Vomiting and stinging eyes ended after first night. Chills ended next day. Body aches ended after 24-48 hours. Fatigue, headache, and loss of appetite lasted into 4/16.
Lump at site of injection. 7x8.5cn red area around site warm to touch. Started on Keflex 250mg tid to treat possible cellulitis.
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 13-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014:
VERTIGO; VACCINE INDUCED NEUROPATHY; CHILLS; CHEST HEAVINESS; TACHYCARDIA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-Mar-2021, the patient started experiencing tingling in various areas of the body at various times of the day. As the days progressed, she had chest heaviness, heart palpitation, and tachycardia. She went to the emergency room three times and was told her symptoms should resolve over time. She was diagnosed with vaccine induced neuropathy on 15-MAR-2021. On 26-MAR-2021, she experienced vertigo. She did not have any of these symptoms prior to using the Janssen COVID-19 vaccine. The tachycardia was not consistent, but happened again a few days ago, and caused concern. Currently she has to see a physical therapist for the vertigo and balance issues that she is experiencing. Laboratory data (dates unspecified) included: Lumbar puncture (NR: not provided) Normal, and Scan (NR: not provided) Normal. Treatment medications (dates unspecified) included: Tylenol (paracetamol) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and had not recovered from vertigo, vaccine induced neuropathy, chest heaviness, and tachycardia. The reporter considered causality between vaccine induced neuropathy, and tachycardia as not related This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210413724 - covid-19 vaccine ad26.cov2.s - vaccine induced neuropathy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
No patient adverse effects. Patient was notified that the covid vaccine used was drawn up for more than 12 hours. Patient offered to recieve another dose and refused.
Pt. states that after receiving the 1st dose of 10/27/2021, started experiencing symptoms 3hrs later of rough cough (lasting a hour), chest burning, (101.2) Fever, Acid Reflux, muscle aches, fatigue, nausea, chills, Heart Rate (120 middle of the night), and sore arm. Primary communications recommendation Follow Up. Symptoms slowly subsiding, shortness of breath continues.
Pt recv vax on 12/17/98; on12/19/98 pt exp apnea episodes x 36 hr