chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About three days after I received the shot, I had a deep ache in my left thigh. I had expected possible aches, but I thought it would go away. Over 5 weeks later, I still have it in that spot, where I have never had pain before. It has occasionally woken me up at night, and sometimes I avoid standing due to the pain.  Also, on August 21 I started my period and by August 22 my menstrual flow was so heavy I was soaking through a super-sized tampon plus a pad liner every 1-2 hours. This lasted through mid-day on August 23, then it slowed to a normal period for me. I have never had such heavy flow (I normally use one super-sized tampon every 8 hours at the beginning of my period). I have had irregular periods for a while now, since I am in peri-menopause, but usually they are lighter than when I was having periods regularly, and never more heavy.  Temporary adverse effects at the beginning (mostly days 1-2 post-vaccination) included prickly random pains in various spots throughout my body, especially my joints, and a numbness/tingling in my face. Also I had a slight intermittent headache, with one that was moderate in my left temple area. These effects went away and were very manageable. But I am concerned about the second vaccine due to my pain which is ongoing in my leg, and my family history of dying from bleeding and clotting, considering that there is a (what appears to be rare)  risk of thrombosis with thrombocytopenia with these vaccines and at least one in vitro study showing increased clotting with the S1 spike protein - although COVID-19 caused worse clots in this study
got a sore arm; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 01-Nov-2020.  This case involved a patient of unknown demographics who had sore arm (pain in extremity), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided   On an unknown date, all the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore arm (pain in extremity), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was sore arm.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
an entire undiluted vial was administered to one patient; an entire undiluted vial was administered to one patient; Flu like symptoms; This is a spontaneous report from a contactable pharmacist. A 33-year-old patient of unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, Expiration Date: Mar2021), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that an entire undiluted vial was administered to one patient on 09Jan2021. The pharmacist asked for recommendations with regards to this concern. The patient had moderate to severe flu like symptoms for 3-4 days in Jan2021 after the vaccine overdose. The day of the overdose, when they realized what they had administered, the patient was admitted to the emergency department for observation for a couple hours. The patient didn't have a reaction and was given an Epi-Pen to take home just in case. The patient had not reported any further adverse reactions after the flu like symptoms resolved. The outcome of the event flu like symptoms was resolved in 2021.  Follow-up (20Jan2021): New information reported from the same contactable pharmacist included: reporter information.  Information on the lot/batch number has been requested.  Follow-up (12Mar2021 and 12Mar2021): New information received from a contactable pharmacist included reporter information, patient data (age), suspect vaccine data (start date/stop date, lot number and expiration date), new event (Flu like symptoms), onset date of events, outcome of event, stop date of event and clinical event course.
approx 9 mos p/ vax pt devel a herpes zoster-like rash w/approx 50 dry, scaly, slightly raised & red lesions.
Hospitalized for possible encephalitis; Problems with thyroid; Prolonged confusion; Weakness; Unresponsive for several hours; Loss of urinary control; Syncopal episode; This case was reported by a physician via call center representative and described the occurrence of encephalitis in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 31st July 2019).   On 3rd September 2019, the patient received the 2nd dose of Bexsero. On 3rd September 2019, 6 hrs after receiving Bexsero, the patient experienced syncopal attack (serious criteria GSK medically significant). In September 2019, the patient experienced encephalitis (serious criteria hospitalization and GSK medically significant), thyroid disorder (serious criteria hospitalization), confusion (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the patient experienced unresponsive to stimuli (serious criteria GSK medically significant) and urinary incontinence. The patient was treated with thyroid medication {nos} (Thyroid Medication). On an unknown date, the outcome of the encephalitis, thyroid disorder, confusion, weakness and urinary incontinence were unknown and the outcome of the syncopal attack and unresponsive to stimuli were recovered/resolved.   It was unknown if the reporter considered the encephalitis, thyroid disorder, confusion, weakness, syncopal attack, unresponsive to stimuli and urinary incontinence to be related to Bexsero.  Additional details were provided as follows: On 3rd September 2019, the physician reported that on day patient had second Bexsero vaccination, the patient was running in a cross country event and experienced a syncopal episode. The event occurred about 6 to 8 hours after patient had received vaccination. The patient was unresponsive for several hours with loss of urinary control. In September 2019, less than 3 weeks after receiving Bexsero the patient experienced possible encephalitis, problems with her thyroid, prolonged confusion and weakness. In September 2019, the patient was hospitalized for 2 weeks with possible encephalitis, problems with her thyroid, prolonged confusion and weakness. The patient's thyroid issue was confusing and did not respond to treatment with thyroid medication. A lumbar puncture and other lab tests were all negative. The patient did not receive a specific diagnosis for event. The reporter was consented to follow up.      Lab Comments: On unknown date, Other lab test were negative.
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis (incorrect product storage). The lot of M-M-R II were reconstituted with properly stored sterile diluent (DILUENT MRK). 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: Original Case : 1709USA000054.
significant joint aches; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "significant joint aches".  Additional information: Reporter withheld shared that following his third dose of the vaccine he experienced significant joint aches starting within the first three days, lessening but still continuing 6 months later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is concomitantly taking medications for high blood pressure.  Patient did not administer any corrective for event.
I had a breakthrough case of Covid-19 on Sunday afternoon boss tested positive but I tested negative but Monday started feeling bad didn't test positive Monday but had fatigue and headache then on Tuesday I tested positive. Tuesday, we, Thursdays felt brutal like I was  hit by a truck. I was prescribed Lagevrio.
Patient called and left a voicemail message that she wasn't feeling well and wanted someone to call her back. I called her at 3:05 PM and asked her to describe what was wrong. She stated that she "wasn't feeling well, having trouble breathing, and my blood pressure is 210." She wanted to know if this was a normal reaction. I told her that it was not, a normal reaction was injection site soreness, cough, fever and or aches. She told me that she called the paramedics and they are on the way. I asked her to get the VIS we gave her, and she hung up on me.
1 week after 1st vaccine, a large red itchy rash appeared on right arm at site of shot.  I applied Extra Strength Benadryl itch stopping cream twice/three times a day.  It last one week.
Patient was given ZOSTAVAX vaccine in her left arm and Pneumococcal -PPV-23 in her right arm. Approximately 15 minutes after the vaccine administration the patient began to complain of feeling light headed. She then appeared to be very tired and complained of a headache and a racing heart. About 30 minutes after vaccine administration she complained of a little tingling in her lips. The paramedics were called and took her to the hospital.  3/30/09 Received ER medical records of 3/6/2009. FINAL DX: weakness, dizziness resolved; hypokalemia Records reveal patient experienced near syncope w/lethargy, general weakness, HA, dizziness starting approx 15 min s/p vaccination.  Brought to ER by EMS.  Tx w/oral KCL replacement & IVF.  Exam WNL, symptoms resolved spontaneously & d/c to home w/PCP f/u. Follow-up: The Dr. at the ER told the pt she was dehydrated and also had low K+ levels so they were not sure she was having a true allergic Rxn.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: She had a horrible taste in her mouth
Pharmacist states he is not sure, but it is a possibility that a patient only received one dose of MMR II as a child.; No additional AE reported; This spontaneous report was received from pharmacist, referring to a currently 36-years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date when patient was a child, the patient  was possible vaccinated with only one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose regimen, lot #, expiration date, and route of administration were not provided) (inappropriate schedule of drug administration). No additional adverse event was reported.
pt devel an elevated t105 w/in 24 hr p/vax w/concurrent course of diarrhea; sibling had a viral illness @ the same time; pt recv vax pt recovered well; pt was treated w/Nystatin oral suspension for oral thrush;
Initial healthcare professional report received on 19 Feb 2010: This patient was vaccinated with FLUVIRIN (batch no unknown) on an unspecified date. The patient acquired Guillain-Barre disease shortly after receiving the vaccine. The outcome of the event was not reported. Follow up report received on 14 May 2010: Two follow-up requests were sent to the report but no response received so far. Hence the case was closed due to lack of response.
Report number 2000032613-1 describes injection site redness and swelling in a patient (age and gender not specified) who recieved one injection of hepatitis-b vaccine for prophylaxis. Concurrent conditions included an unspecified skin condition. Concurrent medications were not specified. Sometime in October 2000, the patient received the first injection of the a hepatitis-B vaccine in the left deltoid. Twenty-four hours later, the patient experienced a swollen and red left deltoid at the site of the injection. Treatment was not specified. The patient did not receive the  second injection. As of November 2000, the injection site reaction was ongoing.  The most recent information, received 10 January 2001, indicated that the patient was seen by a physician, who determined that the redness and swelling of the patient's left deltoid region was due to a long-standing skin condition unrelated to the hepatitis-b vaccine. The outcome of the redness and swelling was not provided.
Muscle aches, particularly in lumbar region, rash to face and feet, erythematous with slight exfoliative appearance on face.
Pfizer COVID Vaccine 1st dose 5/14/2021 (EW0183) 2nd 6/4/2021 (EW0180).    Patient received 2nd Pfizer COVID vaccine on 6/4/21. Patient presented to ED on 6/7/2021 with left sided chest tightness that radiated to shoulder and jaw. Patient was diagnosed with acute myocarditis.
Patient received vaccine at 7:45 pm on 5/19/2021. Chest pain and rapid heart rate occurred approximately 2 hours post vaccine shot. Patient went to ER. Diagnosis was atrial fibrillation with RVR (CMS/HCC). Medication given: Metroprolol 5mg/5ml injection - ADS override pull (10:41pm), sodium chloride 0.9% bonus 1000mL stopped at 5/20 12:36am. Patient spontaneously came out of atrial fibrillation and was released
1055am 4-5cm area of erythema. Ice applied 1cm hematoma. 1125am expanding are of erythema and edema 10cm, ice held. 1135 less erythema, no tenderness, no warmth.
4 hours after: mild headache 6 hours after: increasing headache, body ache, chills 13 hours after: severe headache, body ache, chills, 105 fever 36 hours after: mild headache, 100 fever 48 hours after: symptoms gone
tested positive for Covid after second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid after second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced COVID-19 (tested positive for Covid after second dose). At the time of the report, COVID-19 (tested positive for Covid after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication use was not reported.   It was noted per source that the patient thought he had COVID before getting tested but he did not have any symptoms.   Treatment in formation was not reported.
Partial hearing loss in right ear. Muffled/ringing. Could be tinnitus but not sure.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUL-2018, the patient was vaccinated with doses of improperly stored ROTATEQ taken orally, lot # reported as R003149 with expiration date 19-FEB-2019 (dose, strength, frequency and anatomical location were not reported). Other suspect therapy included RECOMBIVAX HB lot #N011851 with expiration date 19-DEC-2019 (dose, strength, frequency, route, and anatomical location were not reported) both for prophylaxis. The doses of the vaccines were exposed to a temperature below 9.3 Celsius degrees (°C) with a time frame of 8 hours and 46 minutes. There was no previous temperature excursion. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved.
Information has been received from a licensed practical nurse (LPN) concerning a 17 year old female with no drug allergies or medical history who on 30-AUG-2007 was vaccinated IM with the second 0.5 mL dose of Gardasil (lot #658556/1060U). The patient was vaccinated with the first dose on 21-JUN-2007 (lot#658556/1060U). Concomitant therapy included hormonal contraceptives (unspecified). On 30-AUG-2007, approximately three hours after vaccination, the patient developed a fine, red rash all over her body. The patient was seen in the physician's office and treated with methylprednisolone (MEDROL DOSEPAK). Subsequently, the patient recovered. The reporter considered the erythematous rash to be an other important medical event. Additional information has been requested.
On Monday 1/7 my mother had her yearly physical and reported everything was fine and she was in good health. This was confirmed by the physician's assistant. My mother reported getting the PNEUMOVAX 23 vaccine at pharmacy around 12:30 p.m. on 1/9/2019. That evening at 6:25 she sent a text message saying "my right arm is achy from my pneumonia shot and I'm getting chills. I'll go home and take Tylenol."  Then at 7:11 p.m. she reported "I am lying down at home."  This was her last communication. The next morning she was found dead. THIS MUST BE INVESTIGATED IMMEDIATELY IN CASE THERE IS A BROADER ISSUE WITH THIS VACCINE LOT.
Developed pertussis. Two doctor visits. June 24 placed on Azithromycin for "sinus infection." June 28 Pt's sister contracted pertussis. July 18 Dr. said he only had allergies, despite classic whoop and coughing until vomiting for 6 weeks. Daughter positively diagnosed on July 25 at separate clinic.
Patient admitted on 12/9/2021 for hypoxia.  States he tested positive for COVID-19 via home on Saturday after developing congestion and shortness of breath.  Reports fever over the last few days.
Information has been received from a registered nurse (R.N.) concerning a female who in 1996 was vaccinated with a dose of Varivax. Subsequently, "now", on approximately 17-APR-2006, the patient experienced severe case of chickenpox. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. The R.N. also reported that the patient's brother had a severe case of chickenpox (WAES#0607USA01261). Additional information is not expected.
Pt c/o not feeling well after Moderna covid vaccine#2 received in outside facility.  Had covid vaccine on 3/25/2021 around 2pm and started feeling nausea 4-5pm with dry heave, no vomiting. Having acid reflux, mouth watery. Denies throat congestion/tightness. Denies chest pain, SOB, abd pain. Overnight felt warm and cold, nasal congestion.  Today with fever (did not check temp), some headache, dizziness, runny nose, feels weak. Pain by injection site, firm.
Peripheral Neuropathy: 3 years ago I had an adverse reaction to Ciproflaxacin of intense peripheral neuropathy. That lasted for about 1.5 to 2 years but had abated.  After my second dose of Moderna my peripheral neuropathy has returned. Now when I exert myself I get intense PN in arms and sometimes legs.  I also get fatigued easily.  This reaction has not abated so far from April 1 to May 1.
Full body urticaria with inflammation/swelling which causes severe pain with full body rash, as well as dehydration and fatigue. Caused by any and all UV radiation especially-fluorescent lights.  Long lasting damage to skin caused by fluorescent lights, skin discoloration on face and body. I am 37 year old single female, who has been trapped in my bedroom, at my parents home, in the pitch black, since May. My life has completely been robbed from me and I have not been able to work since 5/19/2023. I was an Operating Room Nurse, I had recently within the last 5 years done a career change, this was my second bachelors degree and had finally started making money in a brutal selfless career. However,  I have now  been on disability, working with staff at facility, I am unable to do any kind of work regardless of accommodation the reaction to the light is to severe.   Diagnosis: L50.1 Idiopathic urticaria, L56.8 blistering due to UV light, L50.2 Urticaria due to cold and heat, L55.9 Sunburn, L50.8 Other urticaria, Photophobia(allergic to fluorescent and halogen lights
Almost immediately after receiving the first Pfizer vaccine my throat began to constrict, my heart started pumping and I was having a hard time breathing.  I walked over the the EMT nearby who took my blood pressure which was 188/120.  He asked me if I had forgotten to take my BP meds and I responded, I take no meds.  He told me to take a seat while he took notes.  A few minutes later he took my BP again and it was the same.  He gave me a benedryl and a glass of water.  The swelling in my throat receded somewhat.  He watched me for the next 30 minutes then took my BP again which was 177/120.  Feeling somewhat better, I  waited another 30 minutes and asked the EMT if I could go home.  He took my BP again which was the same and asked me if I wanted to go to the hospital.  I said NO.  I told him I have a BP cuff at home and would monitor my BP which was normal after 3 days.  Needless to say, I have been frightened to get my second shot.