chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33-year-old male patient received bnt162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 31 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative; (Sep2023) Negative; (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 28Aug2023 to 01Sep2023.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300296465 Same reporter/patient,different drug/AE.;
Headache, Myalgia & Fever Narrative:  dose 1 lightheaded dose 2: HA, chills, body aches temp 100.8
Soreness, radiating pain up to shoulder, neck persistent for one week. Pain is constant and prevents a restful sleep. Taking TYLENOL 500mg 1 by mouth every 6 hours for pain.
POOR QUALITY PRODUCT ADMINISTERED; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced poor quality product administered. On 01-JUN-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine  was not applicable. The outcome of the poor quality product administered and incorrect storage of drug was not reported. This report was non-serious.
I received my vaccine, sat in a chair facing the clock and noted it said 5:00pm.  Within a minute I notice tingling and slight numbness of my soft palate.  I found this odd, but didn't notice any swelling or difficulty breathing.  At 5:02 I texted my husband to make sure my Epipen was in the glove compartment in case I needed it later after leaving the vaccination clinic.  Over the next few minutes the numbness increased and started to spread to my oropharynx area.  I noticed my heart beating faster and wondered if my body was subconsciously anxious about the numb feeling even though I didn't feel worried because I was breathing fine.  Very suddenly my heart started to pound very hard, my entire laryngopharynx went numb and I felt like a deck of cards was sitting in the back of my throat.  I looked at the clock, it was 5:07.  I started to feel dizzy and weak, my heart felt like it was about to explode, my hands were suddenly cold, clammy and shaking, I started to get sharp stomach pains similar to other anaphylactic events, but still no effects on my breathing. I looked at the clock, 5:09, I knew I had to tell someone before I couldn't get up to walk.  As I started to talk to a staff member I felt very disoriented and suddenly went from feeling like I was going to faint to very hypertensive with pain shooting into my left arm.  The staff quickly tooth my BP and HR, I noted my BP was 166/100 (I am normally 114/72) and the doctor stated I was too tachycardic and needed to go to the ER.  At the ER I received Benadryl, Pepcid and an IV, but never needed any epinephrine.  The medications resolved numbness and stomach pain.  I left with the feeling of a tight turtleneck around my throat and it continues to come and go.  Every 6-8 hours I have had to take Benadry and a steroid to keep the intense itching numb feeling in my soft palate away.  I still have tightness around my neck that returns every 6-8 hours, but still no airway or edema issue.  I felt like I had anaphylaxis without the edema.
Patient has been in twice, complains about shoulder soreness, not able to move arm without pain. Also says it is cold in morning only left shoulder.
extreme body fatigue, extreme body aches, fever of 102.9, outrageous headache, excessive chills, - took Tylenol and it didn't help until around 8am this morning
Pt received Pfizer x2.  Pt tested COVID + on 8/22/21 and admitted to hospital for COVID on 8/23/2021. Pt received remdesivir and dexamethasone.
on day 11 after the second vaccine purple fingers and toes started with some shortness of breath, by day 14 worsening shortness of breath worsening extremities discoloration and chest pain with breathing
My daughter?s period has lasted 15 days. She usually has it for only 3 days.
New onset chest pain.  Admitted to hospital on 16 April with anticipated discharge on 18 April.  Per pt report, had ECG changes, pericardial effusion, and elevated cardiac enzymes.  (Awaiting consent for release of medical records - Follow up VAERS report to follow).  Symptom: Chest Pain  07/07/2008 MR received for DOS 4/16-19/2008 with D/C DX: Eczema vaccinatum.  Cellulitis Left Deltoid.  Post-vaccination pericarditis. Pt presented with sharp, midsternal chest pain-increased with deep breathing and lying flat, improved with sitting. Pt aslo c/o fevers and dizziness. Recent dx of 2' bacterial infection of smallpox vaccination site on Keflex.
Date of Admission  01/18/2022   Date of Discharge  01/21/2022   Reason for Hospitalization   PER EMS, FAMILY REPORTED PT BEING LETHARGIC AND INCREASED SOB; MILD FEVER.  Hospital Course   Patient is a 85 y/o female with dementia, dysphagia, previous hospice patient admitted for acute hypoxic respiratory failure secondary to COVID-10 pneumonia and suspected aspiration pneumonia.  Grandson is primary decision maker.  Per hospice agency, hospice status was revoked so patient could come to hospital for medical treatment.  Grandson wanted to continue with medical management except for intubation or CPR. She was treated with with dexamethasone, remdesivir, and antibiotics for aspiration pneumonia concerns. Her oxygen requirements were increased on high-flow nasal cannula during hospitalization. Initially she was able to have oxygen requirements decreased to 3L NC.   We had goals of care discussion with family regarding nutrition as patient had been NPO throughout admission. (please refer to addendum on progress note from 1/20/2022). After discussion family wanted to trial patient tube feeds. However, overnight on 1/21 patient had teams called x 2 due to increased work of breathing, oxygen requirement and decreased mentation. After discussion with family patient was transitioned to comfort care.  Discharge Diagnoses      #Acute hypoxic respiratory failure secondary to COVID-19 pneumonia #Suspected aspiration pneumonia #Advanced Dementia  #High anion gap metabolic acidosis #Dehydration  #Underweight  #Hypernatremia  #Pancytopenia  #Anemia of chronic disease     Other Diagnoses   Ongoing  No chronic problems  Historical  No qualifying data        Discharge Disposition  Unable To Determine    Medications  New, Changed, or Refilled Medications  None    Medications to be Continued  acetaminophen (acetaminophen 650 mg rectal suppository) 650 mg, 1 Supp, Rectal, q4h, PRN: fever>100      Discontinued Medications  None  Physical Exam at Discharge       No reaction to verbal or tactile stimulation.  No pupillary light reflex noted, pupils fixed and dilated  Breathing and other lung sounds were absent.  No carotid pulse or heart sound can be heard               Addendum by MD on January 24, 2022 15:02:08 (Verified)    Attestation by MD on January 24, 2022 15:02 I personally saw and evaluated the patient on the result date found in the header of this document.  I independently performed the critical/key portions of the Evaluation and Management service and discussed the management with the author of this document.  I agree with everything documented above.
3DEC98 c/o n/v & h/a-chills;4DEC98 absent from school;phone call to parent who reported virus;
Vomited several times the evening of getting vaccines the next day. Diarrhea began the next day and ongoing.
mom states that approx 1 hr p/vax pt went into shock, lost consciousness, ran high fever & had flat bright red rash which occurred suddenly; dificulty breathing & taken to ER; wont stop crying, lump, cold spells, eyes rolled, limp;
pentacel and ActHib was administered on same day/no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and 0.5 ml single dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ098AAA) on 07-FEB-2020 (Extra dose administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) on 07-FEB-2020.  It was of actual medication error due to Extra dose administered.  It was unknown whether adverse event was noted or not.  Information on the batch number of ACT-HIB was requested.  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 and Module VI of the 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.
Day after injection, 3 p.m. started getting chills, actual shaking. Laid down, felt my body temperature start going up. Kept taking my temperature, sent a message to my doctor. At 102 degrees, I took some tylenol with no effect, by the time it reached 104, I had heard back from my doctor who told me that it would be ok to take ibuprofen at that point. Temperature was down to 99 by bedtime, no more side effects, back to normal with some fatigue by day 3.
Pt reported soreness in her arm that hasn't gone away since the vaccine was administered. Pt wasn't going to ask her physician and hasn't let us know how she is feeling.
I received my Covid booster shot. The next morning I had a low-grade fever, really sore left arm, chills, muscle ache. Both feet had a very cold feeling, but, not to the touch. I had a similar reaction when I got the 2nd shot. This time I noticed an unexplained bruise on my left big toe the day after the shot. The 2nd morning I woke up with a large unexplained bruise on the top of my right foot with a graying area going towards the toes. Neither foot was warm to the touch. No pain. Good distal pulses. I went to the doctors and they ran blood work. No unusual results.  After a couple days the bruises were gone. The cold feeling diminished over a week.
Client developed a reaction to 1st dose of COVID-19 vaccine. Client stated she felt shortness of breath, tightness of chest and trouble breathing at 10:43am. Fire Rescue assessed and evaluated the client.  After 15 minutes of additional observation, client was reassessed and based on evaluation client was free to go.  Client verbalized feeling better and exited the park at 11:15am.
patient experienced: COVID on 29-May-2021 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient experienced: COVID on 29-May-2021 after vaccination) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included GERD, Ear infection (Increase frequency), Calcium deficiency and Tympanostomy tube insertion. Concurrent medical conditions included Osteoporosis, Irritable bowel syndrome and Relapsing-remitting multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), ZOLEDRONIC ACID (RECLAST), PROBIOTICS NOS, CALCIUM CARBONATE, CETIRIZINE HYDROCHLORIDE (CETRIZINE), CYANOCOBALAMINE, MAGNESIUM, SUCRALFATE, VITAMIN B COMPLEX, VITAMIN D NOS, GLUTAMINE [LEVOGLUTAMIDE] and ALGELDRATE, SODIUM ALGINATE (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) for an unknown indication.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced COVID-19 (patient experienced: COVID on 29-May-2021 after vaccination). At the time of the report, COVID-19 (patient experienced: COVID on 29-May-2021 after vaccination) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also includes pumpkin seed extract soy germ.  Patient's past medical history also includes reproductive issues.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Pt received her first dose of the Moderna COVID19 vaccine. While sitting in observation 12:35 PM she reported feeling hot and jittery. Pt has a history of breast cancer, takes Tamoxifen. Allergies are only seasonal environmental. BP 138/78 HR 104 R 12 O2Sat 99% Repeat BP 132/80 RR 12  HR 94 O2Sat 97%  EMS called (1:01 pm) for symptoms not resolving and at the pt?s request. EMS arrived at 1:06 PM. Pt was evaluated and chose not to go to the hospital. Pt signed a refusal with EMS. Pt left clinic at 1:22 PM. Pt was advised to contact her PCP today. Pt was given the information for high risk vax clinic for scheduling 2nd dose.
arm still feels sore; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown demographics, who experienced arm still feels sore (pain in extremity), while he/she received vaccine INFLUENZA VACCINE and while treated with TOFACITINIB CITRATE [XELJANZ XR].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking XELJANZ XR (TOFACITINIB CITRATE) 11 mg (with an unknown batch number).   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient's arm still felt sore (pain in extremity) (Unknown latency) following the administration of INFLUENZA VACCINE and TOFACITINIB CITRATE.  It was reported that he was not experiencing any other symptoms such as weakness, malaise, fever, flu like symptoms, advised the patient to report the soreness to the pharmacy where the vaccine was administered as well as his doctor if the pain does not improve in a few days, patient stated he was still able to exercise and has range of motion, no bruising or swelling.  Lab data was not reported.  Final diagnosis was pain in extremity.   It was not reported if the patient received a corrective treatment.  Action taken with TOFACITINIB CITRATE (XELJANZ XR) was not reported.  The patient outcome was reported as not recovered for pain in extremity (still very sore).  There will be no information available on the batch number for this case.  List of documents held by the sender: none
Pt noticed on 11/18/14 that she got a baseball-size swollen area that was red & warm to the touch. Had just regular muscle pain after the injection with no swelling, but then noticed the above sx on 11/18/14. Did come in to our office where she got her injection yesterday, 11/24/14 & area was still approx. Apple size, red, warm to the touch.
06/29/22 presents to ED for "acute elevated blood pressure and paresthesias". PMHx of "recent covid infection"
Case previously recorded as MA2009-3710. Initial case report received from a consumer via MedCom, on 05 NOV 2009. A 2-year-old female patient was vaccinated with 0.25 mL, split into 2 doses, i.m of S-OIV FLUVIRIN (batch no. 1008136P) on an unknown date. No adverse events were reported. MedCom reference no.: NA09-007646.
pt recv vax 31MAR97 & during the noc 1APR(7 pt exp h/a, fever & emesis;approx 2APR97 pt recovered;
Injection site swelling 4x5 inches., red, hot , itching, sore to touch about 12 hours post injection. 14 days post injection swelling remains - 2x3 inches, red, hot, some itching
Cough; Appetite lost; Fever; covid-19; Headache; Ache; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough), DECREASED APPETITE (Appetite lost), PAIN (Ache), COVID-19 (covid-19) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (Ache) and HEADACHE (Headache). On 21-Mar-2021, the patient experienced COVID-19 (covid-19). On an unknown date, the patient experienced COUGH (Cough), DECREASED APPETITE (Appetite lost) and PYREXIA (Fever). In March 2021, PAIN (Ache) had resolved. On 23-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, COUGH (Cough), DECREASED APPETITE (Appetite lost), COVID-19 (covid-19) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.
Seizures started 2 weeks after the shot. Personality changed. Patient felt scared. Loss of memory. Taking zonisamide 6 pills a day to control seizures.
Upon charting the vaccine given to the patient it was found that the vial of Moderna had expired on 10/15/2021, so the patient received expired vaccine.
Burning in my urinary tract for 3 days, burning in my digestive tract for the next two days, and then UTI symptoms coming and going for the following seven months
Information was received on 07-JUL-2017 from a medical assistant who reported that a 21 year old nursing student (demographics not provided) was administered the 3 dose series of RECOMBIVAX (lot numbers and expiration dates unknown) "at birth, at 2 months and at 6 months" (specific dates were not provided). The primary reporter reported that the patient had "titers drawn" and the result was the patient "had no immunity". The primary reporter reported that the patient has now been administered "the first dose in the second series of RECOMBIVAX (lot number and expiration date unknown) administered on an unknown date in March of 2017". The primary reporter did not want to provide any further information in regard to this patient. The primary reporter also reported that a different patient (see MARRS# 1707USA013254) (demographics not provided) received only 2 doses of RECOMBIVAX (lot number and expiration dates unknown) on unknown dates, also had titers drawn and was considered "immune". The primary reporter did not clarify if this patient was an adolescent when they received the 2 doses of RECOMBIVAX, which is why this is being reported. No additional information was available. This is one of two cases from the same reporter. Additional information has been requested.
This case was reported by a nurse practitioner and described the occurrence of neck and shoulder pain in a 38 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's past medical history included arthritis and an unspecified form of lupus. Concurrent medications included valdecoxib (Bextra).  On 07/02/03 at 07:00 the pt received her first injection of Engerix-B (Lot # ENG5373B6) in the right arm. Nine hours post-immunization at 16:00, the pt experienced pain in her neck and left shoulder.  The pt told the nurse that she thought the events were related to vaccination with Engerix-B.
Immediate localized muscle pain.  After about 12 hours, a strong fever, joint pain in knees and ankles, dry mouth, headache, chills, nausea, still in effect approximately 24 hours after vaccination.
All started roughly 3 hours after injection: slight chills, extreme fatigue, really bad joint and muscle aches, intermittent headache
HUGE lower backache. Writhed on the bathroom floor out of bed. Hobbled with a chair for a walker. Called family GP. Recommends OTC stuff. Some better on day 2. Still not walking right. Minimum movement.
pt had transient stinging during administration. Tenderness and hotness at injection site remained but gradually dissipated, but not completely, over the following 6 days.  The rash around the site reached about 2.5 inches and was slightly swollen during the 1st 24 hours.  On the 4th day after administration, patient experienced one day of nausea and diarrhea with some chills.
Pt reported right sided facial swelling  (no numbness or tingling)  after  admin of 2nd COVID19 vaccine. Pt had been diagnosed with COVID19 on 12/27 between both vaccines. SHe denied any numbness, tingling, weakness, tongue swelling, lip swelling, dysphagia, wheezing or shortness of breath. no eyelid swelling. no rash.
Difficulty sleeping-Pt keeps on waking up at night, decreased appetite, lethargic, vomiting started last night, swollen eyes, facial rash.
04/15/21 vaccine received at 4 pm - no issues noted 04/16/21 slept well overnight. Woke up 6:30 am took temperature higher than usual ~98. Felt tired, went back to bed and slept for another hour. Temperature slowly increasing throughout the day. Feeling tired, fatigued with a  slight headache. Took Tylenol rested and fell asleep - woke up temperature increased to 99.5 (orally) felt more unease with self and took a rectal temperature which was 101.66 - more Tylenol and rest. Slept well into 04/17/21 and by 10 am temperature is normal.
This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. The reporter stated that improperly stored doses of VARIVAX (lot number reported as M033905, exp. date 20-JUL-2018, Lot: M027347 Exp:01-JUN-2018, Lot: M022103 Exp: 04-MAY-2018, Lot: L020000 Exp:02-JUN-2017, and Lot: L013826 Exp:21-APR-2017) were administered to an unspecified number of patients in December 2016, following the initial excursion that was reported on 01-DEC-2016 and not following the most recent excursion that was reported on 07-DEC-2016. No adverse effects reported. A data logger was involved. Temperature was 13.8 Fahrenheit (F) for 13 hours, the previous excursion was of 9 F for 15 hours. This is one several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA002545.