chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with 3 COVID vaccinations who admitted with dyspnea and tested detected for COVID.  Provider d/c note below:  "Reason for Admission: Dyspnea   68 yo with CAD, CHF, COPD, PVD, AAA, DM, smoking history, presented with 2-3 weeks of feeling unwell.  He tested positive for COVID on 5/15 - he had flu-like symptoms   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  treated for chronic obstructive pulmonary disease exacerbation finding of CHF with reduced ejection fraction, history of coronary artery disease, COVID-19 infection  Cardiology consultation   Had cardiac catheterization on 06/02, has CHF with reduced ejection fraction, known coronary artery disease, status post stents False positive findings on CT scan, no significant coronary artery disease requiring any intervention Cardiac catheterization performed from the right radial artery Stent in the coronary arteries are patent There was no obstructive was noted the plaque irregularity is seen.  The area in question as reported by CT scan critical proximal LAD stenosis has no lesion it was a false-positive report. LV-gram shows ejection fraction of 35-40%   Acute exacerbation of chronic obstructive pulmonary disease Continue with DuoNeb, already on steroid in the form of dexamethasone for COVID infection   COVID-19 infection Mild hypoxia, already on steroids, CTA pulmonary shows no pulmonary embolism incidental finding of coronary artery disease Case discussed with infection control patient being removed of severe respiratory isolation, as he is 10 days out of initiation of symptomatic infection   Left lower lung pulmonary nodule-not seen on CTA of the pulmonary artery, however will need dedicated CT scans on follow-up   Coronary artery disease-history of stent,   CHF with reduced ejection fraction-LVEF of 35-40% On Ace inhibitor, lisinopril, beta-blocker, metoprolol, Aldactone Cardiology is planning cardiac catheterization 6/2   Diabetes mellitus- appears well controlled Continue with Lantus at a smaller dose for now Correction insulin, diabetic diet,   Smoking cessation offered, however patient refuses to quit   Recurrent headaches-MRI of the brain was done at the patient's request, no acute abnormality"
neuropathy in hands and feet; I have been left with severe nerve damage in torso; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Apr2021 (Lot number: 53x42-EJ4MB) as dose 1, single and administration date Apr2021 (Lot number: 53x42-EJ4MB) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy in hands and feet"; NERVE INJURY (medically significant), outcome "unknown", described as "I have been left with severe nerve damage in torso". It was stated that the patient had been seriously injured by the Covid 19 vaccine. The patient received 2 doses in April of last year from lot number reported as 53x42-EJ4MB. The patient had been left with severe nerve damage in torso and neuropathy in hands and feet. The patient stated that this was unacceptable and tragic. The patient had spent thousands of dollars trying to get help to no avail.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning a 24 year old female who on 18-FEB-2009 was vaccinated with her second dose of GARDASIL (lot number, route and site not reported). On 18-FEB-2009 when she received this vaccination it was noted that the vaccine was "hard to inject". The patient's left arm became "quite sore" and it became hard for her to raise her arm. She had "deep discomfort". On 26-FEB-2009 the patient was seen by the NP continuing symptoms, sleep problems and pain in the front of her shoulder. An X-ray was negative. A magnetic resonance imaging reported reabsorption in the humeral head and a tiny partial thickness tear of the distal tendon. The diagnosis was possible vaccine injection into the bone. Her complete blood count was normal. The patient also reported less intense pain after her first dose vaccination with GARDASIL (lot number, route and site not reported). The patient did not recover at the time of reporting. Possible vaccine injection into the bone, left arm quite sore, sleep problems and pain in the front of her shoulder were considered to be disabling. Additional information has been requested. 5/12/09 PCP records received. In for routine GYN exam 2/18/09 with normal PE. HPV#2 given in L arm. RN reported injection was difficult.   RTC 2/26/09 with c/o worsening arm soreness, now difficult to raise. Pain with ROM on exam, otherwise WNL. tx: ice, NSAIDS.  RTC 3/16/09 with continued c/o arm pain, now disturbing sleep. Now localized to front of shoulder joint. Sent for X-rays/MRI which showed a partial bursal side thickness tear of the distal supraspinatus tendon and a partial thickness tear of distal infraspinatus tendon.  Assess:  Pain in Limb.
Left arm pain on and off since taken vaccine. More frequent lately and my doctor has sent me for physical therapy where I now go twice a week.
Significant swelling & erythema of L arm (site of injection) w/ pustular rash development.
This spontaneous report as received from a healthcare worker refers to a 7 year old patient of unknown gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unspecified time, the patient was vaccinated with the first dose of hepatitis a vaccine (Manufacturer unknown), which was followed, 4 months and 5 days later, by a second booster dose (the dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). No product quality complaint was involved. Additional information has been requested.
Hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up.
Patient had an allergic reaction to second mRNA vaccine.; Hit a fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Patient had an allergic reaction to second mRNA vaccine.) and PYREXIA (Hit a fever of 103) in a 40-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Patient had an allergic reaction to second mRNA vaccine.) and PYREXIA (Hit a fever of 103). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1000 milligram every six hours. At the time of the report, HYPERSENSITIVITY (Patient had an allergic reaction to second mRNA vaccine.) and PYREXIA (Hit a fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that patient had fever of 103 and was told that at 104 would need immediate emergency care and need to take a room temperature shower. This case is reported for 42nd patient out of 63.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Noted hives and itching at the injection site. On 7/15, increased hives noted on trunk, extremities, groin areas. In the ED, pt was prescribed with antihistamines. Hives gone by 07/18/02.
Strange zit feeling in nasal cavity that moves around; feel the inflammation then moves to another spot ever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL7261) via an unspecified route of administration, administered in arm left on 08Feb2021 12:00 (at the age of 51-year-old) at dose 2, single for covid-19 immunisation. Medical history included babesiosis and known allergies: Asprin. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); lisinopril (LISINOPRIL); fish oil (FISH OIL); colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration, administered in arm left on 18Jan2021 17:00 (at the age of 51-year-old) at dose 1, single for covid-19 immunisation. On 15Feb2021 the patient experienced strange zit feeling in nasal cavity that moves around, feel the inflammation then moves to another spot ever since my second vaccination and continues to this day. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.  No follow-up attempts are possible; No further information is expected.
Ear ache in right ear that feels like it's right behind my eardrum. Also 2 nose bleeds from right nostril in the last week.
muscle weakness of limbs, mouth and throat:  itching rash, nausea, lack of appetite; horrible body weakness Three different steriods, antibotic, vitiams;  every blood test doctor could think of
Immediately after varicella injection - pt developed urticarial type lesions near injection site. Was given BENADRYL 25mg po.
significant rash to face, body.  mild swelling around eyes.  itchy, irritable  all immediately following vaccine, within minutes
The Moderna 6mo-5Years was diluted with 2.2ml of 0.9% sodium chloride (normal saline, preservative -free diluent. Administered .2ml to left vastus lateralis. Parent notified 07/08/22 at 4:55pm of incident. No adverse reaction at that time. Educated parent to signs and symptoms of adverse reactions. A follow up call will ensue with the CDC recommendations for further vaccination information.
HIGH FEVER WHICH GOT SPIKED AND WAS STILL AT 101 IN THE MORNING AND 99.86 AT THE TIME OF REPORTING; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history, no known drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 09:06 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, Laboratory data included: Fever (NR: not provided) 103 F. On 20-MAR-2021 15:00, the subject experienced high fever which got spiked and was still at 101 in the morning and 99.86 at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever which got spiked and was still at 101 in the morning and 99.86 at the time of reporting. This report was non-serious.
2 M old previously healthy boy who was admitted on 01/03/12 after one episode of tonic seizure-like activity with bilateral leftward eye deviation at home 5 hours after receiving his two month vaccinations and two additional episodes while in the ED. He had been in his usual good state of health (no fever, no URI sx) prior to these episodes. In the ED, he received Ativan 0.05 mg/kg x1. CT of brain showed no acute abnormalities. Electrolytes were WNL. An LP was done; the CSF had normal glucose and protein with a WBC of 1. A blood culture, urine culture, and CSF culture were sent along with a HSV CSF PCR. Pediatric Neurology was also consulted for guidance regarding appropriate studies. Patient was started on empiric ceftriaxone and vancomycin, which he remained on until all cultures showed no growth at 48 hrs. Patient did not have any additional seizures while inpatient and remained at baseline (feeding, voiding, and stooling well) throughout the admission. An EEG was performed, which was interpreted as normal. Blood and CSF culture showed no growth at 48 hrs; urine culture was no growth (final); and CSF HSV PCR was negative. Patient is scheduled to have an brain MRI to evaluate for structural or vascular defects that may have contributed to development of the seizures as an outpatient on 01/12/12 and will follow-up as an outpatient with Pediatric Neurology.
Vomiting, diarrhea, muscle aches. Using Tylenol, pepto bismol, and chicken soup.
Ttingling that went up her neck on left side of face; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Ttingling that went up her neck on left side of face) and HYPOAESTHESIA (Numbness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), DIGOXIN, PRAVASTATIN and DILTIAZEM for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PARAESTHESIA (Ttingling that went up her neck on left side of face). 13-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness). On 13-Mar-2021, PARAESTHESIA (Ttingling that went up her neck on left side of face) and HYPOAESTHESIA (Numbness) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No treatment medication details was reported.
Tired; slept for 2 days; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On unspecified date, patient experienced tired and slept for 2 days. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fully vaccinated.   COVID breakthrough infection.   Inpatient hospital stay.   Pfizer vaccine lot # not listed, just dates of vaccine
little sore at site innoculation; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.   This case involves an unknown age patient who reported Vaccination site pain (little sore at site innoculation), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  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, for Prophylactic vaccination.  On an unknown date, it was reported that the patient reported little sore at site inoculation (Vaccination site pain) (Unknown latency) following the administration of Influenza Vaccine.   Th reporter reported that the flu shot will not give you flu. He/he Had his/her flu shot 5 weeks ago and had little sore at site inoculation.  No laboratory data was reported.  Action taken was not applicable. It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Prolonged dermatographia (full body), swelling (hands, face, ears), breathing difficulty (minor), heartburn  Treated with daily Allegra.  Heartburn and breathing difficulty fully treated. Swelling and dermatographia still present but reduced.
What are the side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are the side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are the side effects). At the time of the report, VACCINATION COMPLICATION (What are the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment details were provided.   Reporter did not allow further contact
A DOSE WAS ADMINISTERED FROM THE VIAL WHICH IS OUTSIDE OF ACCEPTABLE REFRIGERATED TIME LIMITS; This spontaneous report received from a pharmacist concerned an adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced a dose was administered from the vial which is outside of acceptable refrigerated time limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a dose was administered from the vial which is outside of acceptable refrigerated time limits was not reported. This report was non-serious.
2 episodes of palpitations - described as onset of fast heart beat, no cause noted (once while sitting) self-resolved in <3min on both occasions, happened 2 days after vaccine.
On 7/4 starting at 9 am until noon, he had substernal chest pain,with radiation to his left upper arm and 4th & 5th fingers.  On a scale of 1 -10, it was a 6-7 at its worst.  Though the pain stopped, he continued to have nausea, decreased appetite, but did not vomit. On 7/5 the pain started again and this time was associated with clammy hands and transient shoulder pain.  he states he had Pfizer vaccine, 1st dose on July 2, 2021.
15 minutes after receiving the first pfizer covid19 vaccine in the RUE, the patient began to develop right arm numbness and heaviness, dizziness, facial pain, and tongue tingling. This lasted for about 30 minutes, and began to improve. The RUE numbness improved, but the facial symptoms were still present. Overall patient felt better. Cranial nerves, heart, lungs, and head exam were reviewed and were grossly WNL. Despite this, patient advised to go to ER for concerns of serious allergic reaction and neurologic symptoms. She refused, stating she will go if symptoms worsen. Advised not to get 2nd covid shot without seeing allergist.
Patient received 1 yr vaccines on 01-15-15. On back of (R) arm there is noted redness and a "bump". This RN did not see child, mom sent me pictures. Advised to go to primary dr to get it looked at. Went to dr. Thought maybe reaction to filler. Gave low dose BENADRYL every morning for a week as reported by mom.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and general malaise. On an unknown date, the outcome of the injection site pain and general malaise were recovered/resolved. It was unknown if the reporter considered the injection site pain and general malaise to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) was calling for another purpose and this case was mentioned casually. No patient specific information was available. The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The healthcare professional (HCP) reported that some patients expressed injection site pain or reported general malaise after SHINGRIX. All the events resolved within a few days of onset.
No further AE details/ No PQC; Dose was administered on 9/9/2023, excursion occurred on 9/7/2023.; This spontaneous report was received from a Health Professional and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-SEP-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection,  lot #W039293, expiration date: 11-DEC-2024, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) following a temperature excursion for 0 hours 30 minutes from minus 14 degrees Celsius (C) up to 10C  and then for 0 hours 30 minutes from minus 10C up to 8C (Improper storage of product in use), it was stated that no previous temperature excursion occurred. No additional adverse event was reported.  This is one of 3 cases from the same reporter.; Sender's Comments:  US-009507513-2309USA009166: