chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed visiting nurse concerning a 10 year old male with no medical history or allergies who on 08-SEP-2000 was vaccinated with a first dose of VARIVAX (Oka/Merck) and on 08-SEP-2007 received second dose of VARIVAX (Oka/Merck) (Lot # 657715/0609U).  There was no concomitant medication.  On 26-SEP-2007, within one day of vaccination the patient developed an injection site reaction.  The patient was seen in the office on 27-SEP-2007 and at that time the reaction was described as red warm heart shaped welt 1x1 inch in the right arm.  The mother reported that the injection site reaction was worse and had improved by the office visit on 27-SEP-2007.  Unspecified medical attention was sought.  At the time of report the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Rash, intense itching, redness, warmth to touch. Area affected include injection site, however it now spreads and includes area under both breasts.
(L) arm, redness, swelling, warmth, itching. Advised to take OTC MOTRIN, Hydrocortisone cream, BENADRYL and observe next 24-48 hrs.
Patient was vaccinated against COVID-19 on 1/14/2021 and 2/4/21 and developed COVID-19 infection 9/25/21.
74 y.o. female patient with history of CHF, COPD, DVT, GERD, HLD, HTN, DM2, Hypothyroidism, and OSA presented with COPD exacerbation and also tested positive for COVID   Hypercapnic and hypoxic respiratory failure Acute COPD exacerbation COVID 19 infection  Obesity hypoventilation syndrome Dyspnea, cough, hypoxia On 4L NC at home but is now requiring BiPAP vs 5L NC Related to COPD/OSA/OHS and COVID infection VBG with 7.30/90.4 - indicating an exacerbation of her underlying baseline hypercapnia CXR no obvious infiltrate, but noted atelectasis and bibasilar hypoaeration S/p BiPAP with some improvement, weaning oxygen as able On decadron for COVID19, remdesivir 10/14-10/19 for COVID; has received 2 vaccinations, no booster COPD management: duonebs/albuterol, Symbicort, singulair, decadron, and theophylline (completed azithromycin) Monitor on continuous pulse ox; Weaned to home O2 Clinically much improved 10/20 agreeable to home discharge   Hx of CHF per chart Last echo 4/27/22 with LVEF 68% and no diastolic dysfunction noted Pro-nt BNP 474 and pt is not volume overloaded on exam Repeat echo showing EF 60-65% and no mention of diastolic dysfunction No indication of acute exacerbation   Atypical chest pain Abnormal EKG Chest pain is right sided and reproducible with palpation of chest wall Trop 26 and 28; ACS ruled out Echo no depressed EF or SWMA Doubtful ACS - suspect more MSK involvement Resolved    Hx of DVT Unclear when but based on chart review it was prior to Jan 2021 Not on any home AC DVT ppx with lovenox and scds   Hx of GERD Continue home protonix   Hx of HLD Continue home statin   Pancytopenia Long standing it seems At baseline
Information has been received from a physician concerning an 18 month old patient who on an unspecified date was vaccinated with first dose of VARIVAX (Merck) (dose, route and lot number not reported). On an unspecified date after being vaccinated, the patient developed zoster. The physician said that the patient survived without any sequelae. It was not specified if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
A few days after shot went to ER, diagnosed with AFIB. Terrible chills, shakes, fever of 102+, generally unwell. Gave medicine but do not recall, was able to be discharged within a day. Very unusual, not history of previous AFIB, generally a very fit person.
5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing  Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone
Grandmother states that she noticed on 08/02/2016 that patient had swelling and redness to left upper arm. Child states there is no pain unless it is touched. Redness noted from three finger breadths below acromion process down to the elbow. Distal pulses noted +2. ROM WNL.
Tired, ached all over & slight headach.  Lasted about 8 hours & then quickly got better. No other problems or returning symptoms.
Acute Respiratory Failure with Hypoxia, Resolved -Secondary to asthma exacerbation, COVID-19 infection and CHF exacerbation. On 2L NC on admit -Treat asthma exacerbation as below, supportive care for COVID, and diuresis as below.    Acute Asthma Exacerbation Mild intermittent asthma -With significantly decreased air passage and bilateral expiratory wheezes noted on exam.  Likely due to COVID-19. -S/p Decadron in the ED and pred 40mg x4 days -Continue prednisone taper with 30mg x4d and 20mg x4d. Continue scheduled bronchodilators. Continue incentive spirometry.   Acute on chronic diastolic CHF -Echo March 2023 EF of 69%, grade 2 diastolic dysfunction, moderate mitral regurg, RSVP 35, post TAVR. On Bumex 0.5mg prn at -Continue home PO bumex.    COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140 COVID Infection -Patient states she is vaccinated x3, last vaccination was in November 2022. Symptoms began 3 days PTA.  Her husband also tested positive for COVID. -With fevers, vomiting, coughing. -S/p Decadron in the ED. Hold Paxlovid given interactions with home meds, esp Plavix given she had recent coronary intervention -Prednisone as above. Supportive care. Special isolation until 6/24/23   Thrombocytopenia, POA -Etiology unclear. Chronic in nature -Plts 122 on admit (baseline 120-140)   Recent Non-STEMI due to restenosis  CAD -During 5/2023 hospitalization. -LHC 5/24 and found to have SVG-D1 restenosis of prior stent s/p DES to prox and mid vein graft -Patient has not been able to tolerate medications in the past few days due to emesis from COVID. -Continue DAPT, beta-blocker, statin.   CAD post CABG -S/p 3V CABG 1986, subsequent DES -Follows with Dr.  -Continue DAPT, beta-blocker, statin, Imdur.   Essential hypertension -Continue home beta-blocker and Imdur   Aortic stenosis -S/p TAVR 2/15/2021 -valve well seated on repeat Echo
Second Dose: on the very end of it she had a slight reaction of like pins and needles but then it went away and she got rid of that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, The caller was fine with the first dose and there was no reaction), for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "not recovered", described as "Second Dose: on the very end of it she had a slight reaction of like pins and needles but then it went away and she got rid of that". Additional information: The Reporter received the booster dose, the third dose of the Pfizer covid 19 vaccine last September. After 2 days the caller started to feel like there are a million pins and needles internal, in her stomach and her body and she was in terrible shape. Can someone tell the caller what to do to counteract the reaction she is having? The reporter is feeling like millions of pins and needles coming out of her body- her eyes, nose, tongue, she can feel it in her chest and in her colon. The reporter went to her primary care provider to get a steroid injection. Usually if the caller has a reaction to something she gets a steroid injection. The reporter generally doesnt like to take the steroid injections. The reporter got a steroid injection yesterday against her doctor's better judgement. The reporter doctor didnt want to give it to her because it would work so hard against something. But the reporter has got to have some relief because she had 3 nights where she didnt sleep. The reporter lays down and it was like a million pins and needles coming out her head, it was so painful and powerful she would rub her head to make sure the pins werent actually there and its horrible. Right now the reporters eyes feel like theyre going to die from all the pins and needles. Does Pfizer know something the reporter can do to counteract this? This has happened really severe. The reporter got her booster dose on 23Sep2021. it was Pfizer because she asked for it. The reporter was fine with the first dose and there was no reaction. The second dose on the very end of it she had a slight reaction of like pins and needles but then it went away and she got rid of that. It did not completely get out of the reporters system because its been on and off. Last Thursday is when this attack started and she went 3 days without sleep because she couldnt lay down.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up  The lot number for bnt162b2 was not provided and will be requested during follow up.
The patient was scheduled to receive the Bivalent booster however received the Monovalent booster in error.
Extreme brain fog; Extreme confusion; short-term memory delays and losses; thinking issues; no concentration; Extremely exhausted; Anxiety over effects; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jan2022 11:00 (Lot number: FJ1614) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXTROAMPHETAMINE HYDROCHLORIDE. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer , prev dose brand unknown=False, prev dose lot number=EW0176,, prev dose lot unknown=False, prev dose administration date=08May2021,, prev dose administration time: 12:00 PM, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 08May2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EW0158,, prev dose lot unknown=False, prev dose administration date=08Apr2021,, prev dose administration time: 12:00 PM,, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 08Apr2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Extreme brain fog"; CONFUSIONAL STATE (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Extreme confusion"; AMNESIA (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "short-term memory delays and losses"; THINKING ABNORMAL (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "thinking issues"; DISTURBANCE IN ATTENTION (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "no concentration"; FATIGUE (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Extremely exhausted"; ANXIETY (non-serious) with onset 22Jan2022 14:00, outcome "not recovered", described as "Anxiety over effects". Therapeutic measures were not taken as a result of feeling abnormal, confusional state, amnesia, thinking abnormal, disturbance in attention, fatigue, anxiety.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Sandoz dextroampamphetamin 30 mg tab received in two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination since vaccination patient not tested for covid-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
I have a red hard lump right at the injection site. If first showed up the first after receiving my first shot and has doubled in size. It is hot to the touch itchy and sore.
Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included Prenatal Multivitamins for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Jun-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant). On 28-Jan-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
5/23/2000;Mother reporting baby has huge knots on both legs, a rash on one leg bumpy-like and he acts like his back hurts when I pick him up. Mom was instructed to take child to MD today and call us back with what doctor said to do. 5/23/2000;TC from mom reports baby has huge knots on both legs, rash on one leg and baby acts like back hurts when she picks him up. Mom states knots are bigger than 50 cent piece. Instructed to call MD, encouraged mom to call back and let us know what PCP said mom stated she would. 5/24/00 TC to mom at work, mom reports called MD and he told her to put him in warm water for his legs and give his Tylenol. Mom reports his legs are bumpy rash on his legs and he cries like he is hurting when I pick him up. Mom asked if PGM could bring him to clinic. 5/24/2000 Slight edema noted on both thighs. Fine prickly rash noted over entire trunk area and both thighs. He didn't cry when picked up or when his legs were moved. He was smiling and cooing. Treatment was to keep him cool, don't wrap him in blanket etc. Instructed PGM to have mom call for any further problems or see PMD.
costochondritis; pain in right part of chest; After first shot, I had swollen lymph nodes under right armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Lot number: EC6818) at the age of 50 years as dose 2, single and administered in arm left, administration date 26Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. Relevant medical history included: "osteoarthritis" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Spinal stenosis" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; LEVOCETIRIZINE. The following information was reported: COSTOCHONDRITIS (non-serious) with onset 2021, outcome "not recovered", described as "costochondritis"; CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain in right part of chest"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "After first shot, I had swollen lymph nodes under right armpit". The events "costochondritis" and "pain in right part of chest" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of costochondritis, chest pain.  Additional information: The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
I had difficulty swallowing with significant pain in my throat so I really could not eat or drink. I was already taking ibuprofen 800 and gargling. I went to the doctor on February 27th and was prescribed antibiotic AUGMENTIN 875 for a week. Once I started the medication it has taken the full 7 days to feel better. I am still recovering as it still does not feel normal yet.
Experiencing left arm pain, at the site of the injection; Experiencing left arm pain, at the site of the injection/Left Arm Sore; This a spontaneous report from a contactable reporter. This consumer (Patient) reported for herself.  A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN6204), via an unspecified route of administration, administered in left arm on 04Mar2021 and second dose of dose 2 via an unspecified route of administration, administered in right arm on 25Mar2021 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: ER8727), as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any prior vaccinations within 4 weeks of administration of covid-19 vaccine. There was no illness reported at the time of vaccination. Reporter stated that starting in April 2021, she began experiencing left arm pain, at the site of the injection. Some days she has the pain and some days not. The reporter asked Is this a side effect of the Pfizer COVID-19 Vaccine. The reporter asked a question on the Pfizer Vaccine. The reporter stated that she had both shots in March and wants to know if there is a side effect where the arm is sore 3 months later, is that normal. First Vaccine was in left arm and second in the right, right arm fine but left sore on and off. The reporter stated that she had arm pain after the shot for a couple of days and then it went away and the pain comes back off an on. The patient stated that it is not hurting and some days it will hurt, and she was wondering why and wondering if it is a side effect. The Patient stated she had left arm pain after the injection but it went away, so the patient further clarified that the pain started in April, but she stated the exact date is unknown. The reporter stated that she had arm pain after the shot for a couple of days and then it went away and the pain comes back off an on. The reporter stated today it is not hurting and some days it will hurt, caller states she is wondering why and wondering if it is a side effect.  Information on Lot/Batch number was available. Additional information has been requested.
Pt reports that from day 7-10 (post vaccine) he had a 'cytokine like response" with redness, swelling and pain extending from left shoulder to under arm and chest area.  Did not see PCP.  Took OTC analgesic, resoled on day 10 post vaccine the response dissipated.
Itching in my left arm at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching in my left arm at site of injection) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL, TAMSULOSIN, ROSUVASTATIN, METFORMIN, OMEPRAZOLE and OMEGA-3 FATTY ACIDS for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching in my left arm at site of injection). On 07-Mar-2021, VACCINATION SITE PRURITUS (Itching in my left arm at site of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided was rubbing alcohol applied topically. Action taken with mRNA-123 is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR received. Second dose event reported. On 04-May-2021: Updated TCR. Second dose event reported.
Pt given MCV-4 on 7-11-2016 approximately 2:30 PM, mother states noticed 7-12-16 in afternoon, injection site red-baseball size, warm to touch, slightly hard - after pt weight lifted. Mother called 8:15 AM 7-13-16, reported reaction, brought child in for verification, told mother to give pt BENADRYL 25mg, IBU and Ice off and on every 20 min.
Headache, fever,muscle pain, redness, itching, tiredness, warmth, pain at the injection site.
person developed chills, cough, sore throat, stuffy nose on monday night (8/2/21) after receiving dose 1 of the Moderna covid vaccine on sunday 7/31/21.  She called the pharmacy on 8/5/21 to report this to us. The symptoms were still happening, but to a lesser degree than the previous days. She did not have any soreness in the injected arm. She took ibuprofen and nyquill for the symptoms, which helped.
Pt received ADACEL RA upper deltoid, PNEUMOVAX RA lower deltoid.  On 11/4/08 since vaccinations febrile, chilling. Has not felt well since.  Negative cough, negative vomiting or diarrhea.  RA lower redened size of tennis ball, red streak going inward around arm.
Patient has been experiencing dizziness off and on. Yesterday it got to the point where she thought she was going to pass out. Reports that her neighbor wanted to call the ambulance, but she refused for her to call.