chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L027431, expiration date reported as 22-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 13.9 degrees Celsius for 3 hours 20 minutes. There was previous excursion of 14.2 degrees Celsius for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aortic dissection, pericarditis, myocarditis.  On arrival, patient appeared critically ill with cool, clammy skin, diaphoretic, complaining of chest pain.  Patient initially able to answer simple questions, however quickly became unconscious, witnessed having tonic colonic seizure activity.  Patient given 2 mg of lorazepam which aborted the seizure, however he remained unresponsive.  IV fluids were started, and patient remained hypotensive after 3 L of fluids.  Bedside cardiac ultrasound was performed which showed a large pericardial effusion with tamponade physiology.  We continued fluid resuscitation and patient was intubated, while stat Cardiology consult was called.  Patient suffered a cardiac arrest shortly after intubation. Cardiology performed emergent pericardiocentesis at the bedside which showed hemopericardium with output of greater than 500 mL of blood.  ROSC was achieved following pericardiocentesis, and we continued resuscitative measures.  Emergent arterial line and central venous lines were placed.  Patient began to have profuse bleeding from all orifices, and massive transfusion protocol was initiated.  Patient was stabilized enough to be taken to CT scanner which showed an extensive aortic dissection extending into the RCA, abdominal aorta, brachiocephalic artery, common carotids, and into the abdominopelvic vasculature.  Cardiac and vascular surgery were consulted stat, and the decision was made to take the patient emergently to the OR.  We were informed shortly after that the patient had expired en route to the operating room and they were unable to obtain ROSC. Final impression: type A aortic dissection, cardiac tamponade. Second dose of mRNA vaccine (unknown if Pfizer or Moderna) received two days prior to event.
light rash started 7PM 2MAY94 under lt arm (armpit) & inside wrist; c/o itching sensation between fingers but no rash @ fingers; next evening 3MAY94 rash red @ umbilicus, around waist, abdo & upper legs (thighs) ending w/large red whelps;
Within 2 days of second shot, Patient exhibited extreme fatigue.  This continued for the next several weeks culminating with the inability to move which resulted in admission to Hospital the week of 2/22/21.  After weeks to stabilize vital systems, a diagnosis of multiple myeloma was obtained. Patient continued to decline until multiple organ failure occurred within 30 days of admission.  Death occurred on 3/25/21.  It is not clear whether the vaccine potentially caused and/or exacerbated a previously undiagnosed condition (multiple myeloma).  However, the proximity of an immune cell related cancer which resulted in rapid decline and death within 60 days of vaccination should be noted in case there are any other previously undiagnosed blood cancers being found in newly vaccinated individuals.
Patient is fully vaccinated against COVID (Pfizer-BioNTech): Dose 1 given 2/17/21, Dose 2 given 3/10/21, and Dose 3 given 10/14/21.  Patient subsequently admitted to Health System for COVID-19 & related symptoms ( onset of productive cough, dyspnea, and decreased appetite with decreased p.o. intake, generalized weakness)
BLOOD CLOT, HIGH FEVER (103), VERY LARGE SWOLLEN LYMPH NODE IN NECK, MUSCLE ACHES, CHILLS, BRADYCARDIA, SEPSIS. HOSPITALIZATION FOR 6 DAYS. SYMPTOMS APPEARED THREE DAYS AFTER VACCINE.
LOW GRADE FEVER, NAUSEA, SORE THROAT. EMPLOYEE STATED SHE TOOK OTC TYLENOL  AND SLEPT IF OFF.
had difficulty breathing; making choking sounds; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case from other health professional (Medical Assistant (MA)) via Media Information (MI- under reference- 00495848).  This case involves a 3 months old female patient who experienced had difficulty breathing (dyspnea) and was making choking sounds (breath sounds abnormal), after receiving HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) via unknown route in the left thigh on 28-Jan-2021.  On 28-Jan-2021, the patient received 0.5 ml first  dose of suspect HIB (PRP/T) VACCINE (solution for injection, lot UJ316AA and expiration date: 08-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination.  On 28-Jan-2021, the patient developed a non-serious had difficulty breathing (dyspnoea) and was making choking sounds (breath sounds abnormal), 1 day following the administration of HIB (PRP/T) VACCINE.  Also reported that the patient and her father came in yesterday, that is on 25-Feb-2021, and reported this events. The parents never called the office or went to the emergency department. It lasted a few hours. MA (medical assistant) states they were not going to give ACTHIB or prevnar 13 to the patient. Also to be noted, inadvertently submitted a PTC (product technical complaint) and to be considered this case AE (adverse event) only.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting,  the outcome was not reported for the reported events.  The caller stated the doctor was away for a month so if additional information needed, safety can email her and she will forward it to the doctor covering for him.
Patient experienced dizziness and nausea appox: 5 minutes after vaccination.  Patient was placed on back w/legs raised for 15 minutes.  Nausea and dizziness and nausea resolved with no further action.
Clinician drew up 1.3 ml of diluent, added it to the vaccine vial, then drew up 0.2 ml, which she administered to the patient. However, after giving the vaccine, she drew up the remaining doses and found that only a total of 6 doses could be drawn up from the vial (not the anticipated 10 doses she should have gotten). Parents were notified on 2/4/2022. Parents reported that patient had minimal side effects of the vaccine and parents declined the offer to repeat the dose in case she was under-dosed or given saline only.
COVID; COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Dec2022 as dose 4 (orange cap; booster), single (Lot number: GK1657) at the age of 10 years intramuscular, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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 included: "Asthma" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: prior to vaccination. Concomitant medication included: FLOVENT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2023, outcome "recovering" and all described as "COVID". The event "covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: Treatment included Tessalon pearls (cough) and Flonase (congestion). The patient has no known allergies.
Developed a rash all over which started 2 days after vaccines and continued until clinic visit on 12/11/2020 which was diagnosed as Gianotti-Crosti syndrome.  Also had upper respiratory infection and serous otitis media diagnosed on 12/11/2020.
Headache, Myalgia, Arthralgia, NauseaVomiting, Chills Narrative:  Other Relevant History:
Nausea; Vomitng; HEADACHE; This spontaneous case was reported by a nurse and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomitng) and HEADACHE (HEADACHE) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver metastases. Concurrent medical conditions included Colon cancer. Concomitant products included LENVATINIB MESILATE (LENVIMA) and PEMBROLIZUMAB (KEYTRUDA).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea), VOMITING (Vomitng) and HEADACHE (HEADACHE). At the time of the report, NAUSEA (Nausea), VOMITING (Vomitng) and HEADACHE (HEADACHE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported
This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste at time of vaccine administration), TACHYCARDIA (Tachycardia evening of 1st dose) and HYPERTENSION (High blood pressure evening of 1st dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste at time of vaccine administration), TACHYCARDIA (Tachycardia evening of 1st dose) and HYPERTENSION (High blood pressure evening of 1st dose). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (Metallic taste at time of vaccine administration), TACHYCARDIA (Tachycardia evening of 1st dose) and HYPERTENSION (High blood pressure evening of 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (High) elevated. On an unknown date, Tachycardia: 55 to 180 (abnormal) 55 to 180.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298677, 2018SA298678, 2018SA298675 and 2018SA298672 (same reporter). This case involves a 29 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ039AA, expiry date: 15-May-2019 via intramuscular route in left deltoid on 25-Oct-2018. The date of last menstrual period was 08-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered today. It was actual medication error due to overdose and inappropriate age at vaccine administration (administered inadvertently administered FLUZONE HIGH DOSE to 29 year old/No reaction). It was reported that inadvertently administered FLUZONE HIGH DOSE who were less than 65 years of age. None of the persons report any reaction at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
? Jan 21st, 2 hours after vaccine headache.  12 pm right side of back hurting last 2 hours, 3 pm neck hurting lasts 2 hours.6pm feet are burning hot to the touch.     ? Jan 22, 12 am Arrhythmias, racing heart rate, uncontrollable shaking, throat is feeling sore and difficulty swallowing. I go to the ER . While waiting to see a doctor my symptoms subside. Dr. prescribes an epi-pen. Explains that they do not know about the vaccine. ? Jan 23, 3am uncontrollable shaking, neck hurting feet burning. 4am nausea, headache still continues. ? Jan 24, massive headache continues, nausea, diarrhea, I go to Urgent Care Center. They do a blood test must wait a few days for results. ? Jan 25, Massive headache continues, uncontrollable shaking ? Jan 26, 2am, headache continues, uncontrollable shaking, burning feet, blood pressure 164/103. Back to Urgent care. Add blood pressure meds. ?  Jan 29, 12 am Shaking, blood pressure168/85    ?  Jan 31st Sunday 7pm, Muscles tightening up in lower body,  chest pain                                                                                                            Symptoms ongoing, Doctors do not know enough about the vaccine to treat the problem.
FLAT RED RASH AREAS ON BOTH ARMS AND ON THE BICEPS; HIVES; FEVER; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced flat red rash areas on both arms and on the biceps. On 09-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, and chills on MAR-2021, and fever, and had not recovered from hives, and flat red rash areas on both arms and on the biceps. This report was non-serious.
Irregular menstrual bleeding; Bleeding was almost two weeks long; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old non pregnant female patient received the second dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: EL1283) via an unspecified route of administration in the right arm on 27Jan2021 at 1600 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included trazadone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), UNISOM and BENADRYL. The patient previously received the first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: EH9899) via an unspecified route of administration in the right arm on 05Jan2021 at 1600, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 21Feb2021, the patient experienced irregular menstrual bleeding and prolonged periods, bleeding was almost two weeks long and was of low flow. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events irregular menstrual bleeding and prolonged periods was unknown, at the time of this report.   No follow up attempts are needed. No further information is expected
pt recv vax & 3 days later 26OCT97 pt exp erythema mult;reporting MD indicated that the event started as a rash on the leg & spread to the entire body;tx w/DPh & event resolved 31OCT97;MD believes Infranix is the cause of the rxn;
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated 4 times with the Pfizer product, having received vaccine on 01/05/2021, 01/29/2021, 10/22/2021, and 04/28/2022. They tested positive for COVID-19 via antigen test on 07/30/2022 at the nursing home at which they were a resident.  I see no indication they were hospitalized related to the illness. They experienced complications of fluid/electrolyte imbalance and COVID-19 pneumonia. They died on 08/05/2022.
Pain in spleen, treating with ibuprofen 400mg prn, persisting pain 48 hours later
Presented with local reaction at site of injection of Yellow Fever vaccine. Red, raised area ~47x60 on arm with c/o itching. Area warm to touch.  Denied any difficulty breathing or generalized itching.  Injection occurred 01/03/2006 noted the "rash" and itching this am (01/05/2006).  Advised to use some Benadryl cream at site and could take an over the counter Benadryl.
Patient c/o rapid heart rate 5 minutes after recieving first covid vaccine. States no h/o allergic reaction to any previous vaccines or medications. Denied any feeling of swelling, shortness of breath. Stated he has a h/o anxiety and was very anxious about vaccine.
Around 4:15PM, employee's arm felt very hot and extremely itchy.  Light pink rash on left upper arm around injection site. No respiratory symptoms. She received diphenhydramine 25mg IM; 15 minutes later she stated her symptoms and rash were improved.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "CAD" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. Past drug history included: Alphagan eye drops, reaction(s): "Known allergies: Alphagan eye drops". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid taken from 26Apr2022 to 30pr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient complained of pain and swelling at injection site. Patient also complained of trouble using the impacted shoulder.
Vaccine given on 3/14/11. Pt. developed a fine red rash - chest, back, legs. No itching, fever. Hive like spots on face noted.
pt c/o dizziness , no SOB, No change LOC pt. was assietd to lie on gurney with BLE elevated to promote circulation to brain. Vitals monitored V/S o2 Sat 98% RH P-73 BP-101/66  RR- 18 Patient verbalized no more dizziness  vitals- BP:105/66 P- 73 R-18 O2 Sat 99%  RA  #21 pt stable and went home
9-10pm on day of vaccine 10/31/22, I had significant chills and diarrhea, which resolved 6 hrs later.  The next morning (11/1/22) I was extremely fatigued and took 3 naps. I also had these symptoms: Slight headache. Joints ached. Skin felt crawly. My pulse increased from usual 50?s per minute to 70-80s per minute.  My heartbeat had double beats every 3rd, 4th, or 5th beat. The background heartbeat was regular, with additional double beats. I was not in afib,  These side effects resolved by the next day, 11/2/23. However, the frequency of afib episodes increased significantly after the vaccine in  October 2022 until June 2023.   I also had two episodes of hives all over my body after the vaccine . First episode was Jan 16, 2023. Second was Jan 20, 2023. I have never had hives in my life.  They have not reoccurred.
Pt had BOOSTRIX on 6/10 and ZOSTAVAX on 6/12. Pt came into pharmacy 6/16 3:10 pm to show us large inflamed area on left arm. Area appeared lower than IM site and more to front of arm than SQ site. Pt advised to go to MD to have it looked at.
pt recv vax 12APR88 & that day devel generalized pruritus; pruritus persisted for several months & a MD dx the sx as allergy to formalin; pt recovered & did not receive any further inj;
March 31, 2021 - second injection was given left arm top and slightly right-not centered in the deltoid muscle.  I yelled, "Ouch," when given the injection because it was very painful..  Since then, my left shoulder has been swollen and painful.  The pain keeps me up at night so I am not getting the needed sleep.  I sometimes wake up in excruciating pain from sleeping on my left arm, which although I try not to, it's my normal sleeping position.  I feel pain throughout the day and my arm range is limited.   May 12, 2021 - treatment is ice 5-minutes a day; aspercreme with lidocaine, arm movement exercise and Alleve.
It is known that this is influenza vaccine; full details of manufacturer, etc are not known.  Patient developed transverse myelitis with symptoms starting a couple of days following vaccine.  Symptoms are improving but patient has residual numbness and pain.
A few seconds after vaccine was given I had a sensation go up my left jawline that felt similar to a nerve pain.  I didn't think much of it and waited the 10 minutes after my vaccine and had no other symptoms.  I left the pharmacy and started driving home and had a sudden sensation of a heaviness in my chest and trouble taking a deep breath.  I also felt like my tongue and throat were swelling slightly.  I had a warm sensation throughout the middle of my back that felt like a heating pad was on it.  I felt light-headed and called my husband.  As I continued to drive my symptoms worsened and I called 911.  I made it home in my car and the ambulance met me there.  My husband called the pharmacy to ask them what we should do and they said that it would be ok for him to give me Benadryl.  I took 15mL of liquid Benadryl shortly before the ambulance arrived.   Within 15-20 minutes, I felt like I was able to swallow better.  In the ER, I received IV Benadryl and Famotidine.  I was also given 800mg of Ibuprofen for a bad headache I developed.  My oxygen level remained in the high 90's and my symptoms were much improved after the IV medication.  I was instructed to continue taking Benadryl capsules for the next few days along with Pepcid to keep my symptoms from flaring back up.  I noticed this morning when waking up that the left side of my face as well as my throat felt odd so I took the Pepcid and Benadryl and symptoms were relieved in 30 mins or so.