chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore left arm at injection site; fever; chills; dizziness; Headache; altered hearing in right ear (similar to tinnitis); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FISH OIL; ISTALOL; OCUVITE [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;SODIUM SELENATE;TOCOPHERYL ACETATE;ZINC OXIDE]; ROSUVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM), administration date: 16Dec2021, when the patient was 58-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 10Mar2021, when the patient was 57-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 17Feb2021, when the patient was 57-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022); VACCINATION SITE PAIN (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022), described as "Sore left arm at injection site"; TINNITUS (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022), described as "altered hearing in right ear (similar to tinnitis)"; CHILLS (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022); DIZZINESS (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022); PYREXIA (non-serious) with onset 04Oct2022 at 20:00, outcome "recovered with sequelae" (2022), described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, chills, dizziness, headache, tinnitus.  Additional information: No other vaccine in four weeks, no covid prior vaccination, no covid tested post vaccination. Other medications in two weeks: Rosuvastatin, Istalol, Occuvite, Fish Oil, Viatmin.  No follow-up attempts are possible. No further information is expected.
chest pain, abnormal EKG, elevated troponin peaked at 15.9, normal echo Admitted to hospital x 1 day Treated with NSAIDS and colchicine
Agitation, Sedation, Anaphylaxis, Rash & HYPOtension
Shortly after vaccination, 10 minutes, Patient complained of itching,  hives were observed on arms, face was red.  Pt stated chest felt heavy. epi pen adminstered .3mg, 50 mg of benadryl given, Patient was evaluated by EMS, vitals stable , hives did not worsen.  Patient was transported by EMS to Emergency Room for further assessment.
Approximately 12 hours after receiving the vaccine, began feeling different with headache, body ache and chills.  Upon arising in the morning  at about 7:45 AM was not feeling well.  Set down at the dining room table with my husband to take my temperature.  While still sitting at the table my husband caught me as I was passing out/fainting.  Bellevue paramedics were  called and transported my to the hospital.  I was alert during this time.  i was transported to the Bellevue Nebraska Medical Center emergency room.  After being checked out in the ER, I was admitted to the hospital for overnight observation.  Released from the hospital about noon the next day.  There were no adverse findings.
Employee calling to report a reaction after receiving a COVID-19 vaccine. Vaccine Name -  Pfizer Vaccine Date - ? 07/01/2021  Is this your first or second dose- Second Date of symptom onset - ? 07/02/2021 Symptoms - ? chills, fever, fatigue, headache and right ear pain Last day of work and shift - ? 07/01/2021 nights Home remedies- Employee stated she took tylenol (500mg) right after receiving COVID-19 vaccine, and then took Motrin after getting home that evening.  Any improvement- Symptoms resolved after 24 hours Recommendation- Advised employee if symptoms return to take Tylenol and/or Motrin according to directions on label, and to inform us of any returning symptoms. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
Customer reports a 2 month old infant was given a dose of pediatric VAQTA; No additional AE reported; This spontaneous report was received from a pharmacist, referring to a 2 month old patient. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with a dose of pediatric hepatitis a vaccine, inactivated (VAQTA), with lot # T018229 and expiration date on 14-DEC-2021 (route of administration was not provided) for prophylaxis. No additional adverse events were reported.
1-2 hours post vax pt developed a rash on right side of face. 1 day post vax pts rash progressing with fever of 103. 2 days post vax pt seen in ER with hives over face, neck and arms, treated with Benadryl and steroid injections. Pt continues to be treated with Benadryl and Prednisone.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain in arm, at a dose of 1 dosage form. On 14-Jan-2021, PAIN IN EXTREMITY (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-223844 (Patient Link).
I am reasonably health. However, since injected the Pfitzer 2nd Booster at facility on May 10, 2022. I have experienced the following side effects that does not seem to go away: Nausea, shortness of breath, loss of appetite, soreness in my legs while walking; unusual cramps and tightness in my ankle and calf muscles causing slowness while walking. Fatigue; tiredness during the day. Little coughs (but not bad). Smell and taste Pinesol especially after drinking lemonade or coke products. Taste buds are off, feels something is on my tongue that doesn't go away. Sometimes chewing foods thick and clumpy to chew. Crave smoothies and water (dehydration). Did Covid Patient Test results negative.
Swollen lymph node in neck on same side as shot given High fever of 102 with chills for 12 hours the day after shot Lymph node is still swollen two days after receiving shot
Vial was stored in fridge for more than 30 days; No adverse event; Patient was administered bivalent vaccine that had been in the fridge past 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days), PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     It was reported that patient had no known conditions and also did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (1st dose) in May 2021; for COVID-19 prophylaxis: Moderna COVID-19 vaccine (2nd dose) in November 2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and Moderna COVID-19 vaccine.    On 27-Mar-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days), PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days) and PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days).    Dosage text for suspect product was reported as initial booster.  Concomitant drugs were not reported.  It was unknown if patient number 1 experienced any AEs.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720479, US-MODERNATX, INC.-MOD-2023-720524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720479:same reporter US-MODERNATX, INC.-MOD-2023-720524:same reporter
Left shoulder cellulitis with rash around upper injection site. Child received 3 injections to left deltoid and 3 injections to right deltoid.
No adverse event; Pharmacist called because an expired MMR II was given to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported.  On 08-MAY-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with lot# t031436, expiry date 15-SEP-2022 (rHA - recombinant Human albumin) for prophylaxis (dose and route of administration were not provided) (expired product administered). The sterile diluent lot# was reported as u027011 with expiration date 02-MAR-2024.
Information has been received from a physician via a field employee referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patient was vaccinated with all three doses of either GARDASIL (lot #, expiration date, dose, frequency, route of administration and anatomical location were not reported) or GARDASIL 9 (lot #, expiration date, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date the patient was diagnosed with cervical cancer. The patient was receiving an unspecified treatment for cervical cancer. The outcome of cervix carcinoma was unknown. The causality between the cervical cancer and GARDASIL or GARDASIL 9 was not reported. Upon internal review, cervix carcinoma was determined to be medically significant.
Patient resaid he had been hospitalized after the first Moderna vaccine and had reported an allergy with a Rash and fever to the hospital.
Information has been received from a physician concerning a patient who was vaccinated with Zostavax (Oka/Merck).  The physician reported the patient experienced an adverse experience.  Additional information has been requested.
In early DEC96 devel lt sided pain later dx as neuritis possibly r//t vax;
devel 4" x 3" area of erythema, edema & pruritus w/in 12hrs of inj;took a dose of DPH but devel agitation (restless legs)
grandparents are due to receive their second dose of the Pfizer Covid vaccine 21Mar2021 but someone in their house is being tested for Covid-19; This case has been considered invalid as there is no indication that the patient experienced an event under BNT162B2.   This is a spontaneous report received from a contactable consumer. This consumer reported for a male patient (grandparent) that:  Serious: No  Drug information: Characterization of drug role: Suspect Proprietary medicinal product name: PFIZER-BIONTECH COVID-19 VACCINE Active Drug substance name: PFIZER-BIONTECH COVID-19 VACCINE  Reporter Subtype: Caregiver Product: PFIZER-BIONTECH COVID-19 VACCINE Dose number: 1  Question: Caller's grandparents are due to receive their second dose of the Pfizer Covid vaccine 21Mar2021 but someone in their house is being tested for Covid-19 and she is seeking further guidance for this. Will e-transmit as potential AE. Response: Referred caller to HCP for further discussion. Provided off-label disclaimer. Informed caller that Pfizer is unable to make treatment recommendations. Spoke from attached document CONS-Can I Receive the Vaccine with a Prior or Current COVID-19 Diagnosis (US) (v2.0) and CONS-who should not get the vaccine (v3.0).   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Added exposure to COVID-19 as medical history and made case invalid as other info not qualifying for AE reporting-medical information.
pt recv vax 28OCT98 & exp sl fever, stretching, stiffening, cough, sniffles, very loose bowel movements, vomiting, odor on head;
The patient is a 92 y.o. male with history of BPH, hypertension, squamous cell carcinoma and dementia presented with generalized weakness and chills due to COVID 19 infection, acute hypoxic respiratory failure and in A fib with RVR.  He was followed by pulmonary, cardiology and palliative team. While his management was in progress, patient expired on 10/17/22 at 1335.    Discharge Diagnoses:   Acute respiratory failure with hypoxia. Sepsis due to covid-19 infection, POA Acute CHF exacerbation, systolic, uncompensated Elevated troponin without chest pain. A fib with RVR Hypokalemia Steroid induced hyperglycemia Benign essential hypertension BPH Severe malnutrition, POA
SOME MILD BODY ACHES; HEADACHE/SINUS HEADACHE; ARM ACHED MILDLY; SLIGHT FEVER; FELT MILDLY BAD; HORRIBLE NIGHT SLEEP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose Number In Series 1) (unspecified manufacturer).  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 01-NOV-2021 for prophylactic vaccination (Dose Number In Series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 01-NOV-2021, the patient experienced felt mildly bad. On 01-NOV-2021, the patient experienced horrible night sleep. On 02-NOV-2021, the patient experienced some mild body aches. On 02-NOV-2021, the patient experienced headache/sinus headache. On 02-NOV-2021, the patient experienced arm ached mildly. On 02-NOV-2021, the patient experienced slight fever. Laboratory data (dates unspecified) included: Body temperature (not provided) 100 deg, 98.4 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever, and the outcome of felt mildly bad, horrible night sleep, headache/sinus headache, arm ached mildly and some mild body aches was not reported. This report was non-serious.
pt recvd flu vax & was 1 of 5 who devel influenza & died;
In May started getting migraines with vertigo. After going to pcp, the ear and nose specialist was assigned a vestibular doctor to run tests. After vestibular tests run and an MRI of the brain (normal) it's been diagnosed I have vestibular migraines . Treatment so far has been with Zoloft and physical therapy.
vaccine spill from the injection site of the thigh after the injection,with no adverse event; vaccine spill from the injection site of the thigh after the injection,with no adverse event; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional. Agency Inquiry Number: 00336435).  This case involves a 7-year-old male patient for whom vaccine spill from the injection site of the thigh after the injection, with no adverse event (Underdose and Exposure via skin contact) was reported, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  On 19-Oct-2020 , patient received a 0.5 mL of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ430AB) via unknown route in the thigh NOS for prophylactic vaccination.  19-Oct-2020, on same day  it was reported that vaccine spill from the injection site of the thigh after the injection, with no adverse event (Underdose and Exposure via skin contact). Nurse reported that the mother is requesting repeat dose and that the vaccine dripped down the injection site of the thigh.  Details of laboratory data not reported.  Final diagnosis was vaccine spill from the injection site of the thigh after the injection, with no adverse event.   It was not reported if the patient received a corrective treatment.  The outcome was not applicable for both the events.
Fever onset night of 12MAY91 t105 ax feb til 18MAY91; morbilliform rash appeared on 16MAY91 on face spread to trunk extremities; Extreme irritability cries out w/o reason, hitting head & clutches back of neck, appears ataxic & afraid walk;
4:30pm-8:00am body chills, body aches, fever, headache Treated with oscillococcinum at 4:00 and 12 midnight - did not help with symptoms  10am on 02/04 fever and headache returned Treated with Tylenol - fever went away within the hour but headache remained 2:00pm on 02/04 nausea and diarrhea Treated with tums and water - did not help with nausea Treated with 3 saltine crackers and Gatorade at 5:30pm - nausea subsided
This spontaneous report was received registered nurse regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB (therapy type digital data logger) (lot # L051124, expiry date 14-OCT-2018) dosing details and route unknown. Concomitant medications were not reported. The vaccines were subjected to temperature excursion of 10.5 degrees C for a time frame of 2 hours and 33 minutes. It was reported that there were no previous temperature excursions. No other symptoms reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  I had to have an appendectomy due to an acute appendicitis. I became very ill about 9 hours after receiving the second Moderna COVID-19 vaccine, then three days later I got very sick ended up in the ER with an acute appendicitis and having an appendectomy the following morning (4th day after the vaccine)
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced dizziness immediately following vaccination. The nurse practitioner reported that the patient was fine and recovered shortly thereafter. Unspecified medical attention was sought. Additional information has been requested.
On March 1st at 10.30 AM Patient called to say he was experiencing dizziness and wondered if it was from the vaccine. Patient was told to come to Walk in for check. Patient came to the walk in clinic that afternoon. Provider reviewed side effects with patient where 1% may feel dizziness. Patient acknowledged and understood that should he have worsening or additional symptoms to seek care at the ER.
1-25-2021- Phone call: pt had cold and cough prior to vaccine. cough worsened 1-28-2021 Phone call: pt requesting provider visit, cough is same and taking tessalon pearls  1-29-2021 Provider in office  visit: pt complain of cough and SOB for 6 days. Getting worse. Temp 101.2, pulse ox 87%, BP 128/70. level of distress- leaning forward to breath. appeared ill. diffuse rales throughout both lung fields, more at bases. Diagnosis Pneumonia due to COVID 19 virus. Sent to ER
Possible vaccine reaction - swollen lymph nodes under left armpit with pain.  I contacted a call center and was advised to report.
Pfizer-BioNTech COVID-19 Vaccine EUA -- Fatigue, nausea since receiving the vaccine.  Took Motrin a few hours after the vaccine.
Information has been received from a consumer concerning a 48 year old male with high blood pressure whose 5-year-old son developed bumps on his back, bottom and left leg (WAES #0805USA04691) after receiving VARIVAX vaccine (Merck) on an unspecified date. On 09-APR-2007 bumps were discovered and little bumps were mainly on his back. All the bumps were red but some had "festered and some had not". The consumer did not believe that the 48-year-old patient was vaccinated with VARIVAX vaccine (Merck). Additional information is not expected.
pain and swelling and hardness in the arm where the injection was given; pain and swelling and hardness in the arm where the injection was given; pain and swelling and hardness in the arm where the injection was given; Information has been received from a nurse via a field representative referring to a 70 years old female patient. The patient's concomitant medication, medical history, drug reactions or allergies were not reported.  On 29-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R033080 with expiration date on 06-JUN-2020, one shot of 0.5 milliliter, intramuscular in the deltoid of the left arm as Centers for Disease Control and Prevention (CDC) recommendation based on age. On the same date (reported as two hours after the injection), the nurse reported that the patient experienced pain and swelling and hardness in the arm where the injection was given after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. There was treatment given for the events. It was unknown if lab diagnostics or studies were performed. The patient called clinic to seek medical attention. The outcome of the events was reported as recovering. The causal relationship between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the events was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014297: