chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 83 y.o. male with history of HFpEF, atrial fibrillation, CKD, COPD, BPH, depression presented with COVID.   Patient reports he began feeling poorly about 3 days ago with generalized fatigue, poor appetite, fever, and SOB.  Patient reports having his COVID vaccines.   In the ED vitals are as follows, temperature 98.6, blood pressure 108/59, heart rate 101, RR 22, and oxygen saturation of 93% on 4L. Labs results were significant for K 3.1, BUN 28, creatinine 1.31, H/H 7.2/22.5, platelet 116, and glucose 107. The rest of the CBC and CMP were within normal limits. Troponin 127-114. Flu swab negative. Chest x-ray showed no significant change in right greater than left pleural effusions with adjacent a  with adjacent atelectasis. Patient was given cefepime, furosemide, duoneb, NSS, and 1 unit PRBC. Patient admitted for observation.    Clinical Summary 1. E faecalis bacteremia. Biventricular pacemaker in place. Bioprosthetic mitral valve in place. Endocarditis. TV vegetation: Blood cultures 2 out of 2 7/26 returned positive for e faecalis sensitive to ampicillin. 7/27 Echo showed EF 55%, mild AS, bioprosthetic mitral valve leaflets are not well visualized, small tricuspid valve vegetation visualized. S/p 2 days of maxipime 2g, 3 days of zosyn. Ampicillin 2g q4h started 7/29; continue. Repeat blood culture 7/30 still positive despite 5 days of abx. ID consulted who recommends transfer as concern for device infection and needs TEE. IV ceftriaxone 2g q12h started 7/31 for endocarditis per ID recs. Repeat BC 8/1 NGTD. Transfer requested and accepted 7/31; patient was transferred to Hospital on 8/3 2. UTI: Urine culture positive 7/26 E faecalis sensitive to ampicillin. Repeat urine culture 7/31 negative 3. COVID. COPD exacerbation: CT pulmonary arteries 7/26 no PE, small left and moderate right sided pleural effusion with adjacent atelectasis. dexamethasone 6mg started 7/25. s/p 5 days of IV remdesivir (completed on 7/30). Seen by pulmonology. MRSA positive 7/27 4. Anemia: On admit H/H 7.2/22.5. s/p 1 unit PRBC transfused 7/26. Last H/H of 9.2/29.6 on 8/2. 5. HFpEF: Echo 10/24 showed EF 65%, abnormal septal motion, mild AS, thickened bioprosthetic mitral valve leaflets. 7/26 BNP 27594. continue home bumetanide 1mg BID. strict I/O 6. Hypokalemia - resolved: K 3.1 on admit; today K 3.9. Continue to monitor and replete as needed 7. Left ankle wound: Chronic. Established with wound care/hospital outpatient. Wound care consulted; seen 7/28/2023 8. Atrial fibrillation: Continue home metoprolol 15mg BID and rivaroxaban 15mg daily 9. BPH: Continue home finasteride 5mg daily and tamsulosin 0.4mg daily 10. Depression: Continue home excitalopram 5mg daily 11. Thrombocytopenia, POA: Mild. Continue to monitor
On 11-20-15, patient informed me that about 24 hours after the FLUVIRIN injection she experienced muscle weakness in the arm in which the injection was given. Definite weakness in the arm and grip of hand. Not severe but very noticeable. No reaction at injection site. Weakness from right elbow down.
Heart palpitations continued throughout the night and stopped sometime after falling asleep that night then started again the following day around 4 in the afternoon and did not stop until after going to bed that night and again on the next day started around 5 or 6 in the evening and did not stop until going to bed that night. Heart palpitations have been very sporadic since lasting5-30 minutes
Administration error: wrong site, given intramuscular into the deltoid instead of subcutaneous.
administered an expired dose of TENIVAC to a patient with no adverse event; Initial information received on 10-Mar-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 12 years old male patient who was administered an expired dose of tenivac with no adverse event while receiving vaccine Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella zoster vaccine (Varicella vaccine); Hepatitis B vaccine; Polio vaccine and Measles, Mumps, Rubella vaccine (MMR)for Immunization.  On 09-Mar-2022, the patient received a 0.25 mL to 2 mL dose of suspect Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult suspension for injection (lot number: U6603AA; expiry date: 05-Mar-2022) via intramuscular route in the right arm for immunization.  On 09-MAR-2022, the patient was administered an expired dose of tenivac with no adverse event (expired product administered) (latency: same day) following the administration of Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for the event expired product administered.
right eye hemorrhage; whole part of my eye is dark blood red; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced right eye hemorrhage; whole part of my eye is dark blood red (medically significant) on 07Mar2021 with outcome of unknown, headache off and on ever since patient had that first vaccine (non-serious) on an unspecified date in 2021 with outcome of unknown. Patient did not know if this were related to the vaccine. Patient had the second vaccine on 09Mar2021.  Information on the lot/batch number has been requested.
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-374427 (Patient Link).
Pain on the evening of injection, next day had hives, redness, itching, heat at injection site, patient did not document a fever pt took BENADRYL and applied cortisone cream.
p/vax pt noted a rash or hives on face & neck;also intermittent purple discoloration of lt foot;advised to to to ER;tx w/DPH;sx nearly resolved by 10AM on 10/22/99;
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 08-JAN-2016 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K011083 with expiration date: 08-AUG-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
This spontaneous prospective pregnancy report was received from a sergeant refers to a 24 years female patient without pertinent medical history, drug reactions or allergies. On 09-OCT-2014 the patient was vaccinated with VARIVAX (Merck), intramuscular, 1 single shot, lot # reported as J012379, expiration date reported as: 03-OCT-2015 (dose was not reported). There were not concomitant medications. On 09-OCT-2014 the patient received VARIVAX (Merck) per requirements but she was pregnant with last menstrual period (LMP) of 29-MAY-2014 and estimated date of delivery (EDD) of 05-MAR-2015. Initial exposure to VARIVAX (Merck) was at 19 week(s). The pregnancy outcome was outcome pending. It was reported that the patient sought medical attention on unknown date. She did not receive any treatment. There were not laboratory diagnostics studies performed. No adverse events were reported. Additional information has been requested.
CAME IN FOR ZOSTAVAX VACCINE.  ACCIDENTALLY GAVE VARICELLA. CLIENTS STILL AT CLINIC AND I NOTIFIED THEM OF ERROR.  WENT AHEAD AND GAVE ZOSTAVAX IN OTHER ARM.  REALIZED WITH INJECTION THAT I SHOULD HAVE WAITED FOR ZOSTAVAX TO BE GIVEN.  I CALLED CDC HOTLINE. NO LIFE THREATENING REACTIONS SHOULD OCCUR.
having a shingles episode mid-vaccination (prior to second dose); This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated that the patient was concerned whether or not having a shingles episode mid-vaccination prior to second dose would lower the efficacy of Shingrix. The reporter consented to follow up.
pt recv vax 9APR96 & worked all day on 10APR96 & by 4-5PM @ home felt extreme fatigue;pain @ inj site;tightness in neck & gen arthralgia;that noc woke up having a noc sweat & felt as though had a fever;did not take temp
Chest pressure and "gulping" need/sensation.  Started immediately after vaccine was given, but patient did not tell staff until about 15-20 min after vaccination.  Mild tachycardia  with HR 80,  BP 134/70, O2 sat 100%, RR 42.  Symptoms persisted and  0.3 mg Epinephrine IM was administered, followed by 50 mg of diphenhydramine. about 30 min after the vaccine was administered.  Patient 's chest discomfort improved within 5 minutes and her "gulping " sensation improved within 10 minutes.  She was then instructed to go to the ER for further monitoring.  She was stable throughout the event.
Shot at 10:30 AM on 11/29/2001. One hour: blurry vision, numbness in both arms and hands. Weak leg (left). At 2 PM blotchy, trembling hands. Joint aches. Headache. Twenty-seven hours later, left wrist and fingers numb, burning and painful.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with improperly stored ZOSTAVAX (dose, strength, frequency and route were not reported, lot # L006381, expiry date: 25-MAY-2016) by an unspecified physician. No adverse experiences were reported. Additional information has been requested.
he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5.  The shivering quickly changed to more of a convulsing and temp got up to 104.7F.  When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding.  But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21.  I could not brush my hair because my scalp was too tender.  I couldn't let anything touch me and put pressure against any part of my body.  Then at 3:30 that afternoon, I went to bathroom and had a bowel movement.  It was so excruciating that I truly though my colon might have come partially out.  I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying.  When I was finally able to go back to the bathroom to flush, I was expecting a large BM.  It was not.  It was about 2" x 1" and soft.  There was no blood.  It just felt like it tore me up.   ****Then at 7:30 PM on 3-5-21 was when things got very serious.  I was sitting down watching TV after a light meal.  Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades.  Within 5 minutes, it was at its worst....I was have rated it 11/10 pain.  The pain was just very deep, behind the spine, about palm sized radius and unrelenting.  My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today."  So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine.  An hour later, these meds hadn't touched it.  I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB).  Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain).  I called another provider who was on call and told her.  She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER.  I was asleep in an hour.  I took it easy the next two days but started feeling back to normal during the days.  I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out.  That following Tuesday, the deep upper back pain returned.
severe headache; fatigue; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus (type 2 diabetic). Concomitant medications included metformin (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID), both for unknown indications on unknown dates. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021, the patient experienced severe headache, fatigue and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported events. The clinical outcomes of the events severe headache, fatigue and joint pain were recovering at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021(at the age of 59-years-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. received injection et that pm started to develop redness & swelling. States had 1/2 baseball size lump at site. Red, warm to touch et painful. Was told to do PO BENADRYL et ibuprofen et apply ice to site.
Information has been received from a registered pharmacist (also reported received by the physician) concerning her daughter who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) SQ. Subsequently, 8 or 9 years later got a breakthrough case of the chicken pox. Titers were checked (results were not provided). At the time of reporting, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
This is the 1st time I ever had a flu shot, Dr. advised after husband had heart by-pass surgery and had us take vaccine. After a few days my right hand thumb pain to bottom joint - would lose grip without warning, items would fall out of hand. Also soreness on back of head with headache running on sides of head to front caused some nausea. After a few more days, noticed pain on bottom on right leg when going up my stairs, calf to knee. Leg would fall, had to hold on to stair rails to stabilze leg otherwise leg would just fall out from under me. Set appoint on December 7th with NP in Dr.'s office. Said could be nerves, gave me prescription Naprosyn and would follow up on 12/21/2017. Took Tests, Blood, Urine.  After taking 2 pills, pain mostly gone, went up stairs without holding rails, leg went out from under me.  Then pain started in my left thumb but not as bad as the right and had grip, and pain in bottom back, spine, then left leg from upper thigh to joint and left side top of arm. On 12/21/2017 NP told me that white cell counts elevated but not alarming. Told me I shouldn't take Flu shots, but did not think it was adversly due to flu shot. Schedule in 6 months. Did not think it was Guillian-Barre Syndrome because the patients she saw with that was hospitalized and very bad.  I had asked her about Guillian-Barre Syndrome because the pharmacist I spoke with stated I should be tested for this, and could have only mild symptons and would eventually go away. The pain in my left leg has gone, and only mild soreness on thumbs, very little back pain, but top right  thigh and joint, plus right top joint on arm pain and now some chest and top back tightness/soreness. Hopefully will go away.
Reactive Rheumatoid Arthritis in Left Arm and bloodshot eyes. Severe pain in left shoulder, elbow, wrist, hand, and the whole arm. Cannot lift arm or reach with arm while flexing muscles. Constant pain, worsens and gets slightly better with Tylenol. Difficulty sleeping when arm pain is bad. Bloodshot eyes. Prescribed allergy meds for eyes. Tylenol arthritis for arm pain, only helps mildly.
Had vaccine 7-March at 4:15 PM. One week later, 14-March, woke up at 8:15 AM with severe BPPV. Went to doctor and had Epley Maneuver performed a few days later.  Then on 23-March woke up at 4:15 AM with another BPPV event.  Again, returned to doctor for Epley Maneuver.  Then on 2-April went to ENT Doctor to have ears checked.  She performed the Epley Maneuver and everything was fine; there was no nystagmus. Then she laid me down on my back and tilted my head off the table and I had the worse dizziness ever, but no nystagmus.  She sat me up.  My BP jumped to 190/100; pulse 100.  I couldn't stop being dizzy. Paramedics took me to emergency room.   After 2 hours the doctor performed the Epley Maneuver, but there was no nystagmus so it wasn't BPPV.  Had CT scan and MRI and everything was clear.  What changed and what may have caused all this was that I had the J&J vaccine prior to all the dizziness.
This spontaneous report was received from a registered nurse and refers to a 14 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
The administration of Kinrix to a 31 months old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 31-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: The administration of Kinrix to a 31 months old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter was a medical assistant. The reporter wanted to know the information about the administration of Kinrix vaccine to the 31 month old patient. The reporter did consent to follow up. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration.
Approximately 24 hours after my booster shot I experienced the following symptoms: Pain in the right side of my head (Nerve pain) 3 to 4 inches on top of my ear. It lasted for about 4 days - It was a sharp pain and I took Tylenol for treatment and it did improve my situation.
Tdap and Menactra were given too early. Tdap not due for 9 years, and Menactra not due for 3 years.
The pt complained of hives on the same arm as injection on 4/13/00. It is very itchy. It was advised the pt call her PMD for meds recommendation.
No additional AE/PQC reported; Caller reported the vaccines were administered after the excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history, allergies, drug reactions were not provided. The patient's concomitant therapies included sterile diluent.  On 10-NOV-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) in dose 0.5 ml, (lot # U017140, verified as valid with expiration date 28-NOV-2022, albumin status: rHa) (dose number, route of administration and anatomical location were not reported) for prophylaxis (Product storage error). The temperature to which the vaccine was exposed was 6 Fahrenheit degrees up to 14 Fahrenheit degrees and the time frame was reported as 4 hours and 14 Fahrenheit degrees up to 46 Fahrenheit degrees for 4 hours and 45 minutes. No previous temperature excursions were reported. No additional adverse event was reported (No adverse event). It was unknown if a digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2203USA001841: US-009507513-2203USA001716: US-009507513-2203USA001578: US-009507513-2203USA001612: US-009507513-2203USA001617: US-009507513-2203USA001688: US-009507513-2203USA001728: US-009507513-2203USA001890:
pt recv vax;7 days later,pt devel 1 day of fever & had a brief febrile sz;to er;adm to hosp for 3 days; tx w/ IV ceftrioxone;
PATIENT WARNED ME THAT HE HAS A NEEDLE PHOBIA, I GAVE HIM THE VACCINE, HE TOLD ME THAT HE DID BETTER THAN OTHER TIMES, HE STAYED SITTING ON THE CHAIR, THEN HE SAID THAT HE FEEL NAUSEATED AND WANTS COLD WATER, THEN HE FAINTED, I CALLED FOR HELP, HIS MOM WAS OUTSIDE THE CLINIC IN THE LOBBY, WE CALLED HER, WE ALSO CALLED 911. HE STARTED WAKING UP AFTER LIKE 5 MINUTES, 911 WERE HERE AND CHECKED HIM, HE WAS OK, ALL HIS VITAL SIGHNS WERE NORMAL, HE LEFT THE PHARMACY WALKING WITH HIS DAD AND MOM.