chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer(patient). This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunization. Medical history included mitral valve prolapse and itching, both from unknown dates and unknown if ongoing. Concomitant medications included propranolol from an unknown date for mitral valve prolapse. The patient reported she received the first dose of the vaccine on 04Mar2021 and about an hour later, after she got home, she had an itching in the throat and body and had no rashes. She mentioned that she was not sure if there was a correlation with the vaccine because her body sometimes itched up and she couldn't swear if it was cause and effect. She mentioned that she consulted with an emergency medical technician (EMT) yesterday for the wax in her ears and they said that her throat was not swelling up. She inquired if non-severe allergic reactions could still be recommended to take the second dose, as she was aware that only severe allergic reactions were contraindicated. She also asked if it was expected for her allergies to get worse by the second dose. She stated she would consult with her "allergologist" about her symptoms. She also mentioned that after the vaccination, she could feel the heart beat a little more, which she could feel through her body. She had a mitral valve prolapse and kept it under control with propranolol. She consulted her cardiologist that day and they mentioned that the vaccine might have revved up her system more and advised her that it was okay to take the second dose. She took a little bit more propranolol and her heartbeat got normal. The clinical outcomes of an itching in the throat and body, and wax in her ears were unknown. The outcome of she could feel heart beat a little more, which she could feel through her body/ revved up was recovered on an unspecified date. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Never missed a period and period late by approx 10 days. Ruled out pregnancy. Stomach cramping from period that I haven?t experienced since I first started getting periods
She's starting to want to itch; Has a rash, it's on her arm (not the one she took the shot at); Also a bit on the arm on the injection, more on the elbow and down; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She's starting to want to itch), RASH (Has a rash, it's on her arm (not the one she took the shot at)) and VACCINATION SITE RASH (Also a bit on the arm on the injection, more on the elbow and down) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included Rash. Concurrent medical conditions included Penicillin allergy (Had rashes) and Sulfonamide allergy (Allergic to sulfa . Had rashes). Concomitant products included LISINOPRIL, LEVOTHYROXINE, EZETIMIBE and METOPROLOL for an unknown indication.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced RASH (Has a rash, it's on her arm (not the one she took the shot at)) and VACCINATION SITE RASH (Also a bit on the arm on the injection, more on the elbow and down). On an unknown date, the patient experienced PRURITUS (She's starting to want to itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (She's starting to want to itch) outcome was unknown and RASH (Has a rash, it's on her arm (not the one she took the shot at)) and VACCINATION SITE RASH (Also a bit on the arm on the injection, more on the elbow and down) was resolving.            Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant information: Events Outcome reported
13 year-old-male experienced bad headache the day after receiving the Pfizer COVID vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 13-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "13 year-old-male experienced bad headache the day after receiving the Pfizer COVID vaccine".  Additional information: 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.
Fevers began night of vaccines to 101.5F continued for at least 3 days when seen by this MD. Taking TYLENOL, MOTRIN with some improvement. Poor oral intake. No vomiting, diarrhea, rash.
Syringe was empty; Didn't receive vaccine; A spontaneous report was received from a healthcare provider concerning a female patient of an unknown age, who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced syringe was empty and doesn't think she received the vaccine.   There were no medical history and concomitant medications provided.  On an unreported date, the patient received her first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   A healthcare provider reported that a patient thought that the syringe was empty and did not receive the vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The events, "syringe was empty" and "doesn't think she received the vaccine" were considered as resolved on an unreported date.  The reporter did not provide an assessment of the events, syringe was empty and doesn't think she received the vaccine.; Reporter's Comments: This case concerns a female patient of an unknown age, who received her first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. and experienced syringe was empty and doesn't think she received the vaccine. There were no reported adverse events associated with the event of syringe was empty and doesn't think she received the vaccine.
For 2 days after vaccine arm and neck ached. March 20, noticed 6 inch rash on upper left arm and was itchy. March 24,  rash still spreading and itchy. March 27, rash continues to spread down arm and is itchy. March 29, rash measured  14" x 7" March 31, rash still there. April 2, rash gone but arm still itchy. April 6, itching stopped.  No treatment for rash.
Patient presented with a rash at injection site 2 weeks after injection given. Treated with cephalexin 125 mg for 5 days.
inconsolable crying from 3PM-11PM;no fever;restless during the noc;intermittent fussiness but consolable;next AM seems fine, per pt mom;
30min post vaccination pt. arm was warm to touch, felt like bad sunburn. 6 hours after moved to neck and down rest of arm. Pt. experienced "ant crawling" sensation over arm and within 24 hours had same feeling in other arm and neck. Muscle spasms, high fever (101 degrees), inc in blood pressure and blood oxygen of 92%, severely nauseous and 137 HR. Weakness and burning in arm vaccinated.
This is a 22-year-old male without significant past medical history presenting with several days of chest pressure after coronavirus vaccination.  His vital signs are stable and he was afebrile upon arrival to the ED with a benign and reassuring physical examination.  His initial EKG does show some diffuse ST segment elevation/PR depression that was not as impressive on a repeat EKG.  Bedside point-of-care echocardiogram shows grossly normal function without obvious pericardial effusion or other acute abnormalities.  Chest x-ray unremarkable.  Laboratory work-up with undetectable troponin and normal BNP.  Incidentally patient was found to have elevated ALT and AST although he is not having any gastrointestinal symptoms.  On repeat history is not had any recent travel or risk factors for hepatitis.  He has not been taking significant amount of acetaminophen at home.  We did obtain a hepatitis panel which did not show evidence of acute infection.  Acetaminophen level was negative.  Mono and coronavirus test were negative.  A right upper quadrant ultrasound was unremarkable.  At this time I do suspect that he may have pericarditis as the underlying cause of his chest discomfort, likely in the setting of a recent coronavirus vaccination.  He does not have evidence of ACS, PE, pneumonia, pneumothorax, life-threatening arrhythmia, or other immediate life threat.  Regarding his transaminitis, he does not have evidence of choledocholithiasis, cholecystitis, acute viral hepatitis, or other acutely emergent pathology.  We will discharge him home at this time with a prescription for high-dose ibuprofen as well as extremely strict return precautions instructions to follow close with his primary care provider.  He was specifically instructed that he needs to have repeat transaminases drawn within the next several days to week and that if he has not heard from his primary care provider by Friday morning he should call his primary care provider's office or walk-in to sick call directly.  He is agreeable with this plan and all of his questions and concerns were addressed prior to discharge.
I have had 3 doses of vaccine. Weeks after my first vaccine, I began having strange health issues that I?ve never had before: ankle swelling, extreme dry mouth with patches on my tongue, tinnitus of ears constantly, aching muscles- my arms are easily fatigued and it hurts to lift them at times. I tire easily.
Pt stated she just "had a little nausea", nausea passed within 5 minutes No change in B/P sats all good Watch for 15 minutes afterward with medics. Last B/P 108/72 96% salts Pt allowed to leave @ 1250; B/P stable; A and Ox3 Respiration even & unlabored, no further nausea
pain in left foot and left calf feels like cramping...has continued since 3 days after the shot. still happening.
This one has been much longer. I woke up with fever, sever headache, joint aches and pain. I had 103 temperature for 5 days, fever, chills, shortness of breath and difficulty breathing . The week after that I had a rash on lower body went all the way down my leg. I saw my dermatologist in march. He gave me triamcinolone . DR. ordered a bunch of test on me . I had a lymes disease test , Cortisol test, hemoglobin, full cbc blood panel , bone density, TSH, progesterone, estrogen
Fever (102.0) oral. Headache. Neck pain. Nausea.
no known adverse effects; patient received a dose of M-M-R II via the intramuscular route in error; patient received a dose of M-M-R II via the intramuscular route in error; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 23-AUG-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, injection site, lot # and expiration date were not reported) for prophylaxis via intramuscular route in error. There was no known adverse effects reported.
Within 5 minutes of the shot: Nearly passing out/blurred vision/intense sweating, went away within a few minutes.  Several hours after the vaccine, however, I had a severely increased pulse, as well as a growing inability to breathe overnight, by ~4:30AM I was struggling to breathe the most (nearly bad enough to go to the hospital) and had over a 120 bpm pulse (over double my average). This happened for most of the night (I was not able to sleep), and only mostly went away by the next night.
Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
8-year-old male presents as a transfer from an outside facility for new onset atrial fibrillation, acute renal failure and COVID-19.  VSS, NAD.  Saturating well on 3 L nasal cannula.  Previously hypoxic on room air. Received Solu-medrol 125 mg IV PTA. Creat 2.9 (prev. 1.2), trop 1.13. COVID positive. Given 5mg Metoprolol IV for HR 113. New onset afib. Rate controlled 90s. On Heparin gtt,
Exactly three weeks after my second dose of Pfizer, I broke out in a red rash all over my trunk, arms and legs. Continued for a week. since then my skin has been peeling.
pt recv vax & devel 2cm red spot & soreness for a few dasy afterwards, whole arm hurt for 3 days, upset stomach, diarrhea episodes a day after;
Persistent, constant ringing in both ears since the second shot.; Some dizziness; Loss of balance; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021, since the second shot, the patient experienced persistent constant ringing in both ears, dizziness, loss of balance and headaches. The events resulted in doctor or other healthcare professional office/clinic visit, and the doctor diagnosed it as tinnitus. The patient had mentioned that there was some data on these symptoms after Pfizer second shot and the doctor said there was not enough data. Therapeutic measures were taken as a result of the events and included treatment with prescription medication and over the counter medications. On 10Jul2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events persistent constant ringing in both ears, dizziness, loss of balance and headaches were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Redness, with a some swelling, of the left arm, starting from the injection site and spreading down and around the arm (almost 6 inches in diameter). No itching reported. Patient visited her doctor, along with her husband (who also had a similar reaction to same shot received on same day). Both of them were advised to take Diphenhydramine. Symptoms still persists till today 10/20/2017.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ oral liquid (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, exact dose was unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one several reports from the same source. Additional information has been requested.
previously received Vaxzevria as dose 1 / received bnt162b2 dose 2; previously received Vaxzevria as dose 1 / received bnt162b2 dose 2; blood in my urine; This is a spontaneous report from a contactable consumer (patient reported for self). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation; Solution for Injection), dose 2 via an unspecified route of administration, administered in arm left on 03Apr2021 11:00 (Age at Vaccination is 59 years) (Batch/Lot Number: EN 6206 and Expiry date was not provided) as dose 2 (initial Pfizer dose), single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included Rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. The patient previously received Vaxzevria, Formulation; Solution for Injection, Batch/Lot number; EP7534b, and Expiry date was not provided) via unspecified route of administration as DOSE 1 on Left arm on 13Mar2021, 11:00 AM for COVID-19 immunisation and reported stating 3 days after the first dose patient developed a blood clot in right calf, never had one before, no trauma, patient was very active on 16Mar2021, 07:00 AM. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood in my urine on Apr2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
This patient had a fast heart beat for a 3 day occurrence. While working on 3-11 shift, Oct 26 and 27, pain on my elbow joints until now; blurred vision, dizziness, and cold, chills on 10/31/2000.
itching; red bump on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and LIMB DISCOMFORT (red bump on the left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (itching) and LIMB DISCOMFORT (red bump on the left arm). At the time of the report, PRURITUS (itching) and LIMB DISCOMFORT (red bump on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
doctor thought she had COPD; asthma; lungs severely compromised; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 13:30 (Lot number: EP969551) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Covid-19", start date: 02Jan2021 (unspecified if ongoing); "Just broke her leg 4 weeks ago" (unspecified if ongoing), notes: On pain medications; "In a wheel chair" (unspecified if ongoing); "Broke 3 ribs/coughing" (unspecified if ongoing); "Broke 3 ribs/coughing" (unspecified if ongoing); "Prednisone raises her sugar" (unspecified if ongoing). Concomitant medication(s) included: DULERA taken for asthma; COMBIVENT taken for asthma; DUONEB taken for asthma; SINGULAIR taken for asthma; PREDNISONE; METFORMIN taken for hyperglycaemia; BENZONATATE taken for cough; XOLAIR taken for asthma, start date: 08Mar2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021 06:00, outcome "recovered" (21Mar2021), described as "sore arm"; ASTHMA (non-serious), outcome "unknown", described as "asthma"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "doctor thought she had COPD"; PULMONARY FUNCTION TEST DECREASED (non-serious), outcome "unknown", described as "lungs severely compromised". The events "asthma", "doctor thought she had copd" and "lungs severely compromised" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthma.  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. Patient mentioned she was taking Prednisone to keep her lungs clear. Patient had to take an allergy shot called XOLAIR however she canceled it because she was about to take her second dose Pfizer COVID-19 vaccine. Now however she was experiencing severe asthma and has to take a nebulizer and she was also advised to take the allergy shot. Patient wanted to verify details as listed above and clarifies hat she was advised that she could get the allergy shot, but now the doctor was telling her to wait a week in between getting her second dose of Pfizer COVID-19 vaccine and the XOLAIR allergy shot. She was already having issues with her asthma that are scaring her and she doesn't want to wait if she doesn't have to. Doctor thought patient had COPD, but he didn't know what he was looking at. Patient stated her lungs were damaged from COVID. Events did not result to emergency room visit.  No follow-up attempts are possible. No further information is expected.