chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Breakthrough  Pfizer Dose 1 1/21/21 (lot not listed in IRIS/ICARE) Pfizer Dose 2 2/10/21 (lot not listed in IRIS/ICARE) COVID Positive 8/23/21  8/23/21: The patient is an 89-year-old female presents to the emergency department today via EMS from Nursing Home with altered mental status, increasing drowsiness and lethargy.  The patient has a past medical history significant for chronic UTI on prophylactic trimethoprim, neuropathy, hyperlipidemia, obesity, anxiety, mitral valve prolapse, and is bed-bound requiring hoyer lift for transfers.   On arrival to the ED, the patient's temperature is 98.5° F, heart rate 104, respiratory rate 18, saturating 93% on room air with blood pressure 155/101.  Later patient satting 88% on room air requiring 2 L supplemental O2 to maintain sats greater than 90%.  Patient's laboratory studies were significant for glucose 150, ALT 35, AST 44, troponin negative, mg 1.7, urinalysis with 15 ketonuria, moderate hematuria, rare bacteria, 1-3 pyuria, 1-3 RBCs. CT chest shows no acute intrathoracic process, mildly torturous aorta, prior granulomatous disease with scattered calcified granulomas in the lungs and calcified mediastinal and hilar lymph nodes.  CT head shows no acute intracranial findings with age-related volume loss and bilateral white matter disease likely consistent with chronic microangiopathic changes.  Chest x-ray shows abnormal cardiomediastinal silhouette likely secondary to tortuous ectatic thoracic aorta and mild pulmonary venous congestion.  EKG shows sinus tachycardia with PACs, right bundle-branch block and inferior T-waves in inferior leads, heart rate 106, QTC 486. Patient administered NS IV 500 mL in Zofran 4 mg IV in the emergency department.   The patient was seen in the emergency department laying in bed with her son at the bedside.  The patient was very lethargic and unable to arouse/keep awake, but would grimace or grown to painful stimuli.  The patient is currently on 2 L supplemental O2 via nasal cannula and saturating in the 90s.  The patient's son reports that she is bed-bound at baseline and they have to use a lift to get her up.  She is a DNR/DNI status.  8/25/21: Patient is admitted hospital, neuro checks performed per protocol, her mental status has improved, has some baseline cognitive deficits and has remained stable. Stroke workup done with the carotid Doppler and echocardiogram is unremarkable.  She does not have any new neurological deficits.  Patient has been febrile in the hospital, her COVID-19 test is positive.  Inflammatory markers ordered, pretty unremarkable.  Chest x-ray negative for infiltrate.  Admission patient was placed on oxygen as she was noted to have 1 episode of hypoxia with pulse ox 88%.  Oxygen has been weaned off and the patient has remained on room air, no further hypoxia noted.  Patient does not need any treatment for COVID-19 at this time as there is no hypoxia on inflammatory markers are at baseline.  She is discharged back to the long-term care facility in stable condition.  Continue Tylenol and the adequate oral hydration.  Monitor pulse ox and the transfer the patient back to ED if hypoxia noted.
Rash to head, 15 days after Varivax given, the rash progress to arms, right ear.  Rash scabbed over by the office visit date of 02/27/04.
one week after second vaccine develop swelling of lips .  treatment with benadrly and ice pack today 05/8/2021 came into clinic and recieved medrol dose pack and instructed to f/u with pcp or if worsening to go toer
Erythema & induration to left deltoid approx. quarter size where vaccine was given.
The first sign was a small swollen spot in my right armpit, the side of my body on which the vaccination was given. The spot was painful, and by the evening of that day, August 23rd, both the hard lump in my armpit and my entire right upper arm was painful and aching. The next day the aching in the arm subsided a bit, but the swelling in the armpit did not. On the third day, the pain was almost gone but there was a lot of redness under the armpit which had not been there before. On this same day, August 25th, I woke up with the same process beginning on the left side of my body. While my right side was experiencing very little pain, redness, or swelling, the left side had quite become swollen and painful overnight. The aching and pain in the left side was more contained the the shoulder and armpit region than it had been days before on the right side. The left side seems to have swollen up more around the spot of lymph node, so the hard nickel sized lump has been almost lost in the swollen flesh surrounding it. Today, August 27th, the right side has no swelling or pain surrounding the lymph node, but the node itself is still a hard lump in my armpit. The left pain and swelling on the left side has receded, and there is now redness on the node and the upper armpit that resembles what the right side looked like two days ago when the pain started subsiding. There is still some pain and considerable swelling on that side, however, in addition to the hard lymph node.
fever of 103 plus for 24 hours, 100 plus for next 12 hours, has resolved, used tylenol 3000 mg per day shaking chills for 12 hours (intermittent) has resolved neck, shoulder, back & joint pain for 2 days, has diminished severe head-ache for 24 hours, mild head-ache for 24 hours, tylenol as above mild to moderate injection site pain mild nausea 2nd day after injection
This spontaneous report as received from a nurse refers to a 26 year old patient of unknown gender. On an unknown date, the patient was inadvertently vaccinated with PROQUAD, albumin status of recombinant human albumin (rHA), lot# reported as N014759 with an expiration date of 30-NOV-2018 (dose, route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Pt received COVID-19 vaccine and approximately 4 minutes later patient began to feel flushed, racing heart, and faint. On exam, pt was slightly tachycardic with flushing to the face and anterior chest. Symptoms relieved after IV Benadryl. Symptoms improved after Benadryl with a resolution of racing heartbeat and flushing. Patient was then monitored for 2 hrs without recurrent in symptoms. Pt discharged home.
Pt received vaccine on 10/11/06. Had reaction on Friday, 10/13/06, 2 AM. Swells at site of injection and pain. Pt was advised to see physician. 16:00 on 10/13/06. No swell as per her LPN. But still pain. Advised again to see physician. As of 10/14/06, 11:00 AM, feeling better, little pain, less swelling and no redness.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 21st April 2018, the patient received the 1st dose of SHINGRIX. On 22nd April 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and headache. On an unknown date, the outcome of the influenza-like symptoms and headache were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and headache to be related to SHINGRIX. Additional information was reported as follows: The reporting pharmacist was the patient himself who stated that after vaccination with the 1st dose of SHINGRIX, next day the patient experienced flu-like symptoms and headache. The adverse events experienced by the patient were resolved within 24 hours.
Started approx 1/17/21 with migraine type headache, then by 1/19/21 had arm soreness, muscle weakness, joint pain and headache. All symptoms improved 1/25/21 except lingering headache which is still current.
16:40 - Moderna vaccine administered RN. 16:54 - Client reported being thirsty and having tingling face.  16:56 - Blood pressure 200/110, pulse 104 bpm, O2 sat 98% on room air.  Client reports tingling face, but denies difficulty breathing, dizziness, and/or swelling of tongue. No observed hives and/or pale skin.  17:03- Blood pressure 208/108, pulse 103 bpm, O2 sat 99% on room air. Client reports tingling face, but denies difficulty breathing, dizziness, and/or swelling of tongue. No observed hives and/or pale skin. Client declined medical staff to call for medical intervention by emergency medical response.  17:10 - Blood pressure 204/108, pulse 110 bpm, O2 sat 98% on room air.  Client reports tingling face, but denies difficulty breathing, dizziness, and/or swelling of tongue. No observed hives and/or pale skin.  Observed flushed skin to chest. Asked client if she would be willing for husband to drive her to emergency room to be medically evaluated, client declined.  17:15 - Blood pressure 206/126. Client declined calling emergency medical response and being driven to hospital by husband for medical evaluation. Client reports being stressed out with life circumstances. Client reports she had not taken her blood pressure medication that day. Client reports having anxiety due to life circumstances and takes anxiety medication. Client reports wanting to go home, take her medication, and lay down.  Recommended client take blood pressure twice daily, log readings, schedule f/u appointment with PCP in one week, and take logged readings to PCP to make sure no adjustment is needed with prescribed medication. 19:50 - F/U call to client's husband. Husband reports taking client's blood pressure at 175/101. Client reported in background that she had take her blood pressure and anxiety medications.  20:30 - Husband text reporting client's blood pressure reading at 163/94.  1/1/2021 at 10:10 - Husband text stating client took her blood pressure medication at 9:30 am and blood pressure  is now reading 130/79.  Husband reports client stated she no longer has facial numbness, but her arm was sore at injection site.
Pt complained of severe pain at injection site and throughout upper arm & shoulder immediately after vaccination. Arm became very swollen later in day. She also experienced headache & started feeling weak.
About a week after vaccine was administered patient had severe pain and some swelling at site of injection. Lasted for about 5 days.
No additional AE reported; pneumovax 23 was improperly stored and administered; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 11-MAY-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T033831 with expiration date 12-JUL-2021, 0.5 milliliter (frequency, route and anatomical location were not provided) for prophylaxis. No additional adverse event reported. The vaccine was stored at a temperature of 9.65 centigrade with a time frame of 192 hours and no previous temperature excursion. Digital data logger was involved.
cdc failed to notify the bivalent was no longer authorized upon authorizing seasonal until the evening of 9/12.
Patient received Johnson & Johnson vaccine 5/17/21. Around 3 days ago 5/23 developed fever, chills with cough. Seen at Urgent care. Evaluated by Dr.
Pulmonary embolism; she had to quarantine and was not able to get her second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she had to quarantine and was not able to get her second dose). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she had to quarantine and was not able to get her second dose) had resolved.        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.   Concomitant product use was not provided. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Diarrhea; This is a spontaneous report from a contactable consumer. A 78-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and multi vit (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Mar2021 at 14:00 the patient experienced diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 09Mar2021, the patient underwent lab test and procedures which included nasal swab and the result was unknown. The clinical outcome of the event diarrhea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt reports that she had another period 2 weeks instead of 4 weeks after her last period/menstrual cycle.   She usually has a regular 4 week menstrual cycle.  This was 2 weeks early with heavy bleeding for 5 days, followed by lighter flow for a few more days.  Wanted to report as this was unusual for her.
screaming fit x 2 hrs approx 30 mins p/receiving vax; no high temp or other probs;
In October of 2021 I was diagnosed by local Hospital - by Ultrasound - with DVT blood clots in my lower right leg.  I started with leg pain/cramps the first Monday of October.  I started using store-brand Tylenol and heating pad.  I noticed on Tuesday night that it appeared my lower right leg was swelling.  The generic Tylenol and heating pad did not relieve symptoms.  I then went into my Primary physician's office -  on Friday 10/8/2021.  I was seen by a general nurse practitioner.  She noticed my leg was swollen, and sent me for a stat ultrasound at the same Hospital that day.  The ultrasound found that I had 4 veins in my lower right leg with DVT clots.  local Hospital put me on 1 month of blood thinner Xarelto.  I am finishing this initial dose today - Friday 11/5/2021.  Dr. did see me for a follow up visit and has put me on another 3 months of Xarelto.
Right deltoid slightly swollen,red and warm, left deltoid slightly swollen slightly red, warm, compress ibuprofen.
Patient received Moderna on 9/17/21, called facility on 9/27/21 to report redness at injection site. Patient encouraged to contact PCP or care.
Chills, pain. Dizziness. Extreme fatigue, inability to stand, nausea, inability to move arm.
PATIENT SELF REPORTED ON 9/30/21, DATE SHE WAS TO BE DUE TO 2ND DOSE OF COVID VACCINE, DUE TO HER HUSBAND WAS SICK IN THE HOSPITAL UNABLE TO COME TO RECEIVE 2ND DOSE OF PFIZER VACCINE. PATIENT STATES, " APPROX. 6PM ON 9/9/21, THE DATE OF HER FIRST DOSE OF PFIZER, SHE FELT LIKE HER THROAT WAS TRYING TO CLOSE ON HER." PATIENT WAS TAKEN TO ER VIA EMS AND TREATED FOR ALLERGIC REACTION AND WAS D/C HOME. PATIENT AGAIN SAME FEELING EARLY MORNING ON 9/10/21, AND WAS TOLD BY HOSPITAL TO TAKE BENADRYL ORALLLY AROUND THE CLOCK FOR 24 HOURS. SHE WAS FULL RECOVERED BY THAT EVENING ON 9/10/21. RN SUPERVISOR CALLED DR., MEDICAL DIRECTOR. WITH THE EVENTS THAT OCCURED AFTER RECEIVING THE FIRST DOSE OF PFIZER VACCINE, SHE DOES NOT RECCOMEND PATIENT GETTING 2ND DOSE OF PFIZER. PATIENT WAS THEN CALLED AND COMMUNICATED THESE RECCOMENDATIONS. PATIENT VERBALIZED UNDERSTANDING.
Information has been received from a RN concerning a 6 yr old white female who on 02Dec99 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccinations included Hib conj vaccine (manf unk), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, hep B virus vaccine rHBsAg (yeast) (manf unk), measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  and poliovirus vaccine inactivated (unspecified). Illness at the time of vaccination included right otitis media. The RN reported that on 08Sep04 the pt developed a rash characterized by 30+ vesicular lesions that started on her leg and spread to the trunk. The pt was also noted to have a mild fever. On 09Sep04, the pt presented to a physician's office and no other symptoms were noted. On 16Sep04, the pt recovered from the rash and fever. Additional information is not expected.
mental fogginess; headache; dizziness; to a lessor extent:  nausea.   Symptoms started around the first of May and have continued to present.   Fogginess has become much more regular. No treatment received
Immunization nurse was watching client and saw that she was about to pass out. Client had a convulsion of the legs, arched her back and passed out while the immunizations nurse was holding her. Came around very quickly with smelling salts. Patient placed in recliner chair, given juice and crackers.
pt recv vax & exp itching & flushing of upper head, neck, face, arms & eyebrows 10 min p/vax;7OCT96 pt treated w/DPH;pt also broke out in red blotches that itched & had numbness of the lip & tightness in throat;sx resolved w/in 1hr;
This spontaneous report received from a patient concerned a 6 decade 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 ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced full blood count decreased. Laboratory data (dates unspecified) included: Full blood count (NR: not provided) Decreased. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of full blood count decreased was not reported. This report was non-serious. This case, involving the same patient is linked to 20220209734.
10  hours after shot nausea, chills (shaking from chills, lymph nodes under arm pit swollen and painful, pain at injection site 13 hours after shot dry heaves, nausea, chills, difficult to put arm down due to pain in lymph nodes in armpit, fatigue, joint aches Fatigue , joint aches and swollen lymph nodes for 48 hours after shot
p/vax seen by MD;hosp w/ Dx acute gastroenteritis c/clinical dehydration 5 to 6%; possible exposure to Camphylobacter jejuni enteritis;disch
Out break at site of injection, patient reported noticing on weekend, seen in office by nurse (nurse visit) doctor did (5/3) also examine. Patient instructed to use CALAMINE for itch, stay out of sun. Already on ALLEGRA for allergies. Spoke w/patient again 5/6 several lesions now on back, chest and other arm. Original ones are crusted over. No fever. Reported mild headaches only.
3/21/2022- Sent from a UC for SOB and Covid + test.Was taken., was weak and lethargic  over last couple weeks, regularly on 2L NC at HS.  84% o2 sat on RA, placed on 4L NC, o2 rose to 94%. T: 101.1, HR: 130 RR:27.  WBC: 23.4  D-Dimer:1505  CXR: bilateral pulmonary infiltrates and small bibasilar pleural effusions. ABG:7.37/45.4/74/26.3  on RA.  Ordered decadron, baricitinib, remedesivir and Cefepime. 1 dose of lopressor, HR down to 110-120. Start vancomycin ,Zosyn, pipercillin tazobactam and metronidazole for possible aspiration pneumonia. Admit acute hypoxemic respiratory failure s/t Covid 19 pneumonia in the setting of parietoalveolar pnuemopathy. Bipap placed fio2 60
- Very fatigued within 4 hours of injection - muscle / body aches within 7 hours, became worse within 14 hours and ended within 48 hours, especially stiff neck and shoulder pain - Restlessness, chills/shivering, tossing and turning and strange dreams/sleep patterns during first night after vaccine shot - felt very heavy within 12 hours, ended within 36 hours - exhausted within 12 hours, ended within 36 hours - fullness and ringing in ears within 12 hours, ended within 36 hours - low temperature within 12 hours, ended within 36 hours - no appetite for 36 hours - low grade headache started at 12 hours, ended within 40 hours
Severe chills, chest tightness, achiness, lethargy, low grade fever (99)
Swelling in the face; redness in the face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in the face) and ERYTHEMA (redness in the face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SWELLING (Swelling in the face) and ERYTHEMA (redness in the face). At the time of the report, SWELLING (Swelling in the face) and ERYTHEMA (redness in the face) outcome was unknown. Not Provided
Severe shaking, started 12hrs after shot. Continued 12 hrs after that.
Narrative:  COVID infections following completion of COVID vaccine series 02/15/21 COVID vaccine dose #1 03/09/21 COVID vaccine dose #2 07/23/21 Pt reports cough, low grade fever temp 99.4, O2 sat 98, runny nose; COVID POSITIVE 07/24/21 Pt reports chills, cough, diarrhea, fever, headache, sore throat, runny nose; rx given for acetaminophen, ascorbic acid, aspirin, cholecalciferol, DM/guaifenesin, famotidine, loperamide, throat lozenges, zinc 07/26/21 Pt reports improved runny nose; denies fever, cough 07/27/21 Pt reports he is feeling better and stable 07/29/21 Pt reports fatigue 07/30/21 Clinically resolved, isolation end
Severe headache, swollen painful arm site where shot was given, red rash, hot arm, fluish feeling, nauseated, felt like I had a temp. then broke into cold sweats, throwing up, slept for 24 hours.
Child may have received 0.5 cc of pediatric Moderna vaccine that was labelled as "single-use vial" and should have received 0.25 cc.
Headache Myalgia, Fever, NauseaVomiting, warm itchy injection site swollen on 1st day and on 3rd day it only feels warm/itchy, chills, fatgue,  Narrative:
Fever of 100, aches, watery eyes, puffiness underneath eyes, diarrhea.