chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a adult female patient who received HAB (Twinrix) (batch number 9RT94, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The nurse reported that a dose of Twinrix was given to the patient and it was already expired.  The health care professional (HCP) reported that patient born in 1964, with full DOB (date of birth was unavailable). Adverse event contains all reported information by HCP.  The HCP gave consent for safety team to follow up. The reporter consented to follow up. Additional Supportive Information: The use of Twinrix dose which was already expired on 24th May 2022, which led to expired vaccine used.
Ongoing swelling of two lymph nodes in right armpit/breast tissue, as well as fatigue and recurring canker sores.
Swollen arm at injection site.  Swollen lips Hives on hands and feet that progressed into full body hives all over  Extreme fatigue
Symptoms began at about 8pm with muscle aches over entire body.  At about 1:00 am, extreme sweating, extreme nausea, feeling faint. I could not stand without feeling like I was going to pass out. These symptoms subsided within 2-3 hours. Afterward, muscle aches continued, stomach hurt, loss of appetite until about 7:00pm the following day.
See above...itchiness and redness at site...not a big problem, but thought you should know.
Hours after my shot , I got extremely tired and went to sleep. During sleep I awoke to my face feeling numb with muscle spams, my arms felt numb and like lead weights. The face numbness and facial muscle spasm lasted about 6 hours. The arm numbness and feeling heavy lasted about 12 hours.
Welts all over my body.; skin hurts, feels pricey; skin feels pricey and hot. All over body, face, head; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 12:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 (also reported as 15Apr2021), the patient experienced welts all over the body, her skin hurts, her skin feels pricey and hot, all over body, face and head. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events Welts all over my body, her skin hurts, her skin feels pricey and hot, all over body, face and head were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient previously suffered from Tinnitus. Within 24 hours after receiving Moderna shot, Tinnitus grew markedly worse and has not subsided or returned to the pre-vaccine level. This side effect was NEVER disclosed to the patient. Had patient known this, he would NEVER have gotten the Covid-19 vaccine because living with heightened Tinnitus is unbearable.
Information has been received from a health professional concerning a 12 week old male who on 13-JUL-2007 was vaccinated with a dose of Rotateq (Lot# 657291/0669U). On 06-AUG-2007 the patient experienced hematochezia. Upon internal review, the patient's hematochezia was considered to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Severe chest pain, particularly the heart.; Severe chest pain, particularly the heart.; This is a spontaneous report from a Non-contactable Other HCP (patient herself). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 19Aug2021 13:15 (age at vaccination: 25-years) as dose number unknown, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history included covid-19 prior to vaccination, from an unspecifed date and unknown if ongoing. Concomitant medications were not reported. The patient was not tested for covid post vaccination. On 24Aug2021, patient experienced severe chest pain, particularly the heart. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment regimen was given as a result of the adverse events. The outcome of event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
immediate headache and numbness in left arm sick for a week went to diabetic doctor and obgyn and have labs to be drawn
expired dose of VARIVAX administered to a patient; This spontaneous report was received from registered nurse (inconsistent information: also reported as a consumer) referring to a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent (manufacture unknown).  The patient's pertinent medical history, concurrent condition and previous drug reaction or allergy were not reported.   On 05-NOV-2020, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, strength, route of administration and anatomical site of vaccination were not reported, lot # R029517, expiration date reported and validated as 14-OCT-2020) for prophylaxis (expired product administered). The action taken of varicella virus vaccine live (oka/merck)(VARIVAX) was not provided. No additional adverse event was reported.
First dose had to stay for a while itchy rash got fever for both high for alot of days, since then have had alot psychological things happen like unable to talk normal, hormones embalancer
Patient sitting down; reported pressure in the front portion of head. Felt dizzy. Provided water and performed breathing exercises. VS taken. BP elevated. Patient waited additional 10 minutes. Patient felt better.
Supraclavicular and cervical lymphadenopathy beginning 1 day after injection and worsening over the course of the next 4-5 days.  As of 2 weeks since receiving the vaccine the the lymph nodes remain enlarged.
Information has been received from a 63 year old male with no drug reaction/allergies and no pertinent medical history, who on 23-DEC-2010 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. On 25-DEC-2010 "two days after vaccination" the patient experienced swelling. No diagnostic laboratory tests were performed. The patient's swelling persisted. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Itching with bumps present seemed to start on lower legs & ankles.  Itching & bumps have spread to both legs (in entirety), both arms (in entirety), and some portions of torso.  No other explanation can be provided.  Symptoms are still present as of this moment.
contracted covid 19; contracted covid 19; sore throat; fever; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient in his Late 60's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. Patient had severe response to initial Covid vaccine. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "contracted covid 19"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown". Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (did not feel well). At the time of the report, MALAISE (did not feel well) outcome was unknown.            No concomitant medications were reported. No treatment medications were mentioned   This case was linked to MOD-2021-306534, MOD-2021-306464 (Patient Link).
Information has been received from an RN concerning a 39 year old white male who on 1/23/01 at 09:00, was vaccinated with Hep-B, IM, in the LA (1047J). On 1/23/01, at 14:00, the pt experienced shakiness, dizziness, general weakness, warm feeling, a BP of 140/84, lethargic, pulse tachy and pale. The pt was seen at the health dept and encouraged to drink lots of fluids and rest. The symptoms continued until bedtime that day. The pt was able to sleep. Subsequently, the next morning, the pt awakened feeling "ok". The pt's symptoms resolved on 1/24/01. The pt's experiences were considered to be disabling. No further information is expected.
I was driving suddenly everything in front of me went vertical (cars looked like they were standing on end). Happened twice, lasting a few seconds then stopped.
3 weeks and a few days after the day I got my shot, i started experiencing tachycardia and shortness of breath. I went to my cardiologist and he prescribed and Echocardiogram and ecg. The Echocardiogram showed that I was experiencing pericarditis with Pericardial effusion and my eco showed a sinus tachycardia.
Skin crawling, nerves going out of control, loss of muscle tone. Infections everywhere and cognitive problems haven?t been able to complete one task for 2 weeks. Can?t see properly either
p/vax pt devel a rash;tx w/DPH & rash is getting better & going away;
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016465696) on 31-Oct-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient had swollen arm. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Unresponsive, sonorous respirations. BP 73/43, pulse 38, diaphoretic, pale, cold, abnormal EKG, called ambulance.
Myalgia, Fever, Diarrhea, NauseaVomiting, chills, Narrative:
Neck ache progressing to severe/debilitating neck pain over the next 3 days. Ibuprofen does not help. Hard to lie down and bend/turn head.
Menactra was administered as the 2nd dose in a series instead of Bexsero; Menactra was administered as the 2nd dose in a series instead of Bexsero; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate schedule of vaccine administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENACTRA for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and the 2nd dose of MENACTRA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The Menactra was administered as the 2nd dose in a series instead of Bexsero, which led to  inappropriate schedule of vaccine administered and wrong vaccine administered. The follow up would not be possible as no contact details were available.
Client's mother called 5-18-2022 and stated that her daughter started developing a fever during the evening of 5-17-2022 that got up to the high of 103 degrees. Mother gave client tylenol around the clock which helped bring down the fever, but mother stated clients fever went back up to a high of 102 degrees 5-18-2022. Clients mother states her daughter is acting completely fine and normal other than having the fever.
I still have throat discomfort and a very recent endoscopy confirmed my entire esophagus, stomach, and small intestine are still inflamed, but I am feeling much better than before the vaccine; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history included covid-19 from Jan2021 to Jan2021, pneumonia from 2021, throat swelling from 2021, neck swelling from 2021, pain from 2021. Concomitant medications were not reported. It was reported that, patient wanted to thank Pfizer directly for offering the Covid-19 vaccine, and share patients unique experience how it helped me within ONLY 24 hours which patient actually captured on video! These were the only email addresses patient could find so patient hope this routes to the appropriate party. Patient was diagnosed with Covid-19 in Jan2021 which developed into several symptoms, including pneumonia and constant throat and neck swelling which resulted in pain 24/7. Considered a long-hauler, many of my symptoms lasted 4 months UNTIL patient received the first dose of the Pfizer COVID vaccine. Patient had been to several doctors, ENT, pulmonologist, cardiologist, speech Therapist, gastro, and even paid for a 30 minute consult, Silent Reflux was the diagnosis for patient constant throat/neck pain and swelling. Patient would periodically make videos for patient family to provide them updates on patient health, and wanted to share patient condition right before patient left patients home to get first dose of the Pfizer Covid vaccine, and then 24 hours after that first dose. Since these were made for patient family please excuse the loving gestures. Patient truly blessed and thankful it has helped!!! patient still have throat discomfort and a very recent endoscopy confirmed patient entire esophagus, stomach, and small intestine are still inflamed, but patient feeling much better than before the vaccine. The patient underwent lab tests and procedures which included endoscopy: inflamed (entire esophagus, stomach, and small intestine are still inflamed) on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a 72 year old female with no known allergies and high blood pressure and cholesterol who on 29-JUN-2007 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX. Concomitant therapy included lovastatin (manufacturer not reported), HCTZ and atenolol. On 30-JUN-2007 the patient experienced rash on right buttock and thigh. The patient had sought unspecified medical attention. As of 02-JUL-2007 the patient's rash on right buttock and thigh persisted. Follow up information indicated that the patient was given a topical steroid. The out come was recovered on 04-JUL-2007. The reporter indicated that she does not believe that the rash was secondary to ZOSTAVAX. There were not relevant diagnostic tests or laboratory data. No additional information is expected.
Client presented to vaccination site for Moderna booster dose (.25ml). Lead nurse was notified by vaccinator that needle disconnected from syringe during vaccine administration in left deltoid, resulting in unknown dose of vaccine being injected into client's arm. Vaccinator also reported that drops of vaccine remained on client's skin and that small amount of vaccine was noted in safety feature of needle. Lead nurse counseled vaccinator and recommended that vaccinator confirm that needle is firmly connected to syringe consistently prior to vaccine administration. Lead nurse will also review vaccine preparation protocol with vaccination team. Verp sumbitted. Client denied any symptoms during course of stay at vaccination site and left site without any complaints.
dizzy, lightheadiness, sweating, nausea, water offered, symptoms resolved, pt went home
Patient was administer 0.3 mL of undiluted Pfizer Vaccine. Pt. offered MD exam to include EKG and troponin levels with follow up. Pt has no complains.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, age group, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, laboratory data included: SARS-CoV-2 (severe acute respiratory syndrome-CoV-2) test (NR: not provided) diagnosed with a breakthrough case of covid. The patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210818073.; Sender's Comments: V0: 20210817422-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Got Td shot on 07/02/2003: only noticed a sore arm that day. Next day arm was sore but no noticeable area of redness. On 7/4/03 in the evening, noticed red area where she had gotten shot: area was warm, red, hard and warm. Continued to be red, warm and hard today 7/7/03..
tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (Patient) reported that:  A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 08Feb2021, 4 days after the vaccination the patient had tested positive for Covid-19 along with her husband who had scratchy throat and assumed that was from allergies. Patient wanted to know about 2nd shot of vaccination. The outcome of the event was unknown.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Myocarditis; This is a literature report for the following literature source(s) Here we present a case of myocarditis occurring less than 24 hours after the second dose of Pfizer-BioNTech vaccine with 3 month follow up. A 23 year old man received his second dose of the COVID-19 vaccine in the morning. Within a few hours he experienced chest pain, chills, weakness, and fatigue. These dissipated by 7pm. He is a member of the National Guard and during drills the next day experienced stabbing substernal chest pain for which he sought evaluation. The pain radiated into his left jaw, worse with deep inspiration and worse in the left lateral decubitus position. He is a 1 smoker with no personal or family history or cardiac disease. A friction rub was heard on physical exam. His troponin I peaked at 2.6ng/mL. His EKG showed normal sinus rhythm, a TTE showed a normal EF with no pericardial effusion. He was given aspirin 81 mg and started on a heparin drip for possible NSTEMI. The next day his pain decreased and a cardiac MRI demonstrated no inflammation. His serum coxsackie and parvovirus titers were negative. He was instructed to continue the aspirin, limit exercise for 8 weeks, and stop smoking. Upon follow up 3 months later the patient denied any recurrent chest pain and was advised to continue the aspirin. But the original bout of myocarditis limited his participation in the Guard. Our case illustrates that exposure to an immunological trigger, the COVID-19 vaccine, leading to myocarditis was extremely short compared to typical cases of viral induced or vaccine hypersensitivity reaction.; Sender's Comments: The company cannot completely rule out a contributory role of Pfizer-BioNTech vaccine to the onset of myocarditis based on the close temporal association and the compatibility with the known safety profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.