chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her daughter who on 22-JUN-2009 was vaccinated with the first dose of GARDASIL. On 22-JUN-2009 the patient fainted shortly after she took her first GARDASIL. The patient's outcome was unknown. No further information is available.
Beau's Lines, grooved horizontal lines noted in both thumb nails, in addition noted in three fingernails right hand plus 2 fingernails of left hand. No treatment- should resolve as nails slowly grow out. " Not reported " reaction W all three vaccines received- Arm pain at injection sight, 4+ cm swollen large area, red, itchy, with pain resolved five days post vaccine.
Patient with local swelling and redness at the site of the injection. Injection given on left upper thigh. Patient with fussiness and crying per mom since the injection was given. Able to be consoled but when injection site touched patient cries. Acetaminophen 80mg given PO. Ice pack applied. Home management advice given per protocol on immunization reaction. Dr aware and also assessed site.
Shortly after the injection Pt experienced  disorientation. (Received the vaccine at 0900 and disorientation happened later that morning.  Saturday February 27, 2021 experienced muscle weakness and pain. This progressed into the inability to stand or walk.  Seemed to migrate up the ankle and into the legs.  Was confined to a wheelchair for a few days.  Was being seen daily or every other day by APRN who works with Dr. By March 10, 2021 was able to stand with a walker.  Was improving daily.  Talked with Pt on March 15, 2021 and she is now walking without any assistance and feels back to normal
In May I had severe tingling in my hands and feet and a lot of pain in my fingers it lasted about 6 weeks, I went to Doctor late May and June and he did a bunch of blood work and my test came back abnormal so he referred me to a rheumatologist.
no adverse effects; Product reported as GARDASIL but lot # valid for GARDASIL 9; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This non-valid spontaneous report as received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On 10-MAR-2020, the patient was vaccinated with improperly stored doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL),0.5 milliliter, intramuscular in the right arm for prophylaxis; meningococcal acyw conj vaccine (dip toxoid)(MENACTRA), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TETANUS TOXOID). Reporter reported quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) with lot # 1621931 which was not valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). However, lot# 1621931, expiration date  26-JAN-2022 was valid for  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).No adverse event was reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275
Menstruation lasting 17 days following second dose. Regular one week menstruation June. Two week period July. August 20th started a period of bleeding and still bleeding after 55 days, including poached egg sized clots, hemorrhaging, and hospitalization.
Her arm broke out in a large red rash below the injection site on her arm. It cleared within a week.
ACT-HIB reconstituted with sterile water rather than the diluent provided with no reported adverse event; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient who got act-hib reconstituted with sterile water rather than the diluent provided with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 21-Feb-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE at a dose of 0.5 mL once (lot-UJ635AAB,30-Nov-2022) via intramuscular route in the right vastus lateralis for iimunization.  On 21-FEB-2022 the patient developed a non-serious event "act-hib reconstituted with sterile water rather than the diluent provided with no reported adverse event" (product preparation error)(latency-Same day) following the administration of HIB (PRP/T) VACCINE.  It was reported "ACT-HIB vaccine was reconstituted with sterile water rather than the diluent provided with the ACT-HIB".  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event act-hib reconstituted with sterile water rather than the diluent provided with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning a 66 year old male who in June 2007, was vaccinated with the first 0.65 ml dose of ZOSTAVAX (Merck). In February 2009, the patient broke out with really bad case shingles. The physician reported that the shingles was from the neck up and there was ophthalmic involvement. At the time of this report, the outcome was unknown. The patient was seen by the physician and sought unspecified medical attention. No further information is available.
Information has been received from a Registered Nurse (R.N.) concerning a female patient who was vaccinated with a second dose of Gardasil. The nurse reported that after taking the second dose of Gardasil the patient developed a seizure disorder. The nurse alleged that the patient's private physician reported the adverse event (unspecified physician). No other symptoms, treatment or information available. It was unknown if patient sought medical attention. The outcome was unknown. Upon internal review, seizure was determined to be another important medical event. Additional information has been requested.
Evening hours, after receiving immunization on 11/30/01. 18 month old client was taken to CR Hospital in Dahlonega for check out pain in joint and fever 102 was seen by PMD.  Ruled out Flu "probably DTAP" per clients guardian.
Initial unsolicited report received from a consumer (Case Coordinator) on 31-Oct-2017. This case involves a 81 year old female patient vaccinated with FLUZONE HIGH-DOSE (batch number, expiry date, dose in series, route, site were not reported) on an unknown date. Patient medical history not reported. It was also reported that patient had no known drug allergy and chronic illness. Concomitant medications were not reported. On 26 Sep 2017, unspecified time post vaccination, the patient experienced breaking out in a very itchy rash on the left torso. Lab data and corrective treatment were not reported. At the time of this report the event was ongoing. List of documents held by sender: none.
This is a spontaneous report from a contactable consumer. A 67 year-old female patient received a single dose of PREVNAR 13 subcutaneous in the middle area between her shoulder and her elbow on 03Feb2015 at 12:30. She had read the information on how to administer the vaccine and it stated that it should be given in the deltoid or butt area in the muscle. At the time of the vaccination there were not any other relevant medications or medical conditions. No other vaccines were given on same date along with the suspect vaccine or four weeks prior. The patient began to experience pink area at the injection site about 3 hours after she received the shot, at 15:30. She stated she was not recovered from the reported event, injection site was still pink but she did not have fever and it was not bothering her. Follow-up (13Mar2015): Follow-up attempts completed. No further information expected.
Having nerve/muscle pain in right upper arm.  Pain with certain movements of arm and difficulty using arm due to pain with use.  Awaiting appointment with VA to have issue evaluated.
After the first dose on 4/23/21 I got itchy hives/rashes on my arms about a week later and figured it was posion ivy from the yard and was prescribed prednisone on 5/6/21. The hives/rashes went away after the prednisone cycle then came back a couple days later and I was prescribed more prednisone on 5/13/21 then received my second covid dose on 5/14/21 in the morning and started to get hives/rashes that night. I woke up with hives/rashes all over my arms legs stomach and neck. I had trouble breathing and was brought to the emergency room at hospital on 5/15/21 by my wife. I was given multiple IVs, steroids and a breathing mask. I was released that day and had to go back the next day with the hives/rashes returning all over my body and was released that day. I seen my primary doctor on 5/17/21 and 5/20/21 who prescribed more prednisone and referred me to an allergist. With him I spent about 6 months on prednisone and multiple medications such as hydroxyzine, famotidine and multiple allergy medications all to no avail. The hives/rashes would come and go all over my body including my face and legs. I was eventually approved for and prescribed Xolair around October and need 2 injections a month to control it. I'm currently still taking xolair with hopes to space out the doses and hopefully get off it all together.
Onset of swelling in r upper arm extending to 50% of right upper limb within 24 hours of immunization, associated fever. After 24 hours developed blisters in same area. Seen in Emergency room. Treated with Prednisone, Benadryl and antibiotics with improvement.
11 days post vax, the pt developed a rash on anterior and lateral lower torso, pubis to bottom of breasts and arms which became pruritic. The rash was characterized by hyperemic individual lesions which wer 4-7 mm and slightly raised. A doctor visit was required. She was treated with Zyrtec, Benadryl and prednisone. The prednisone treatment consisted of 40 mg PO X 1 day then decreased to 20 mg X 3 days. She visited the doctor again and he treated her with prednisone with 40 mg PO X 5 days then decreased to 20 mg PO. She visited the physician again and at that time the symptoms were resolving, so the prednisone taper continued. The most recent information received reports the outcome of the event is resolving.
Fatigue; Chest pain; Short of breath; Hot; Tingly; Flush; Heart racing; Oxygen level low; Tachycardia; Anxiety issues; A spontaneous report was received from a healthcare professional concerning a 47-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, anxiety issues, difficulty breathing, fatigue, chest pain,  tachycardia, and low oxygen saturation.  The patient's medical history includes contact dermatitis.  Concomitant product use were not provided/unknown by the reporter.  On 28 Dec 2020, approximately five minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection.  On 28 Dec 2020 the patient felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation.    On 29 Dec 2020 the patient experienced fatigue, chest pain, and shortness of breath.  She was triaged to the emergency room where her EKG and vital signs were normal.  The events were treated with oxygen and cetirizine.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, warm and tingly, flushing, experienced rapid heart rate, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation was considered resolved on Dec 28 2020. The outcome of the events, fatigue, chest pain, and shortness of breath, was considered unknown.; Reporter's Comments: This case concerns a 47-year-old female patient, with medical history of contact dermatitis with polyethylene glycol containing makeup and shampoo products, who experienced a serious unexpected event of dyspnea and non-serious unexpected events of feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, anxiety, and chest pain, and non-serious expected event of fatigue.The event of dyspnea, feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, and anxiety occurred 1 day (same day) after first dose of mRNA-1273, lot # unknown. The event of    occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included nasal oxygen and Zyrtec. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
At 8am on the morning after receiving the first Covid 19 Booster, I felt woozy and fainted and fell to the floor.  I came to very quickly and was very lucid.  I did experience some light-headedness for the next few days, but am fine since.  I have never experienced any side effects from any medicines before.  I have never fainted before in my life.  I am on no medications and am generally an active and very healthy person.  I did not seek medical attention after the event.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Significant FU appended (Second reporter Information is updated)
pt was immunized lt clinic & mom drove back because pt hands were cupped, body tense, back arched, head came forward & then dropped;BP 116/60;c/o nausea, dizzy, arm & leg weakness, stomach hurts,skin pale;BP 114/60;
Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm) and FATIGUE (Tired). At the time of the report, MYALGIA (Sore arm) and FATIGUE (Tired) outcome was unknown.            No concomitant medications or treatment details were reported.
Red, hot, swollen area at shot site. Extreme itching and jittery, antsy feeling in body starting 2/24/2021 and this evening on 2/25/2021 it is slightly worse with a bigger and redder lump and much itching. The nurse advised me to take two zertec and apply hydrocortisone cream which o have done. Applied the cream many times today.
pt recvd vax; redness, pain, swelling, ittching at site p/ dose 2 & 3 lasting 1-5 days; ha 3 days p/ dose 3 lasting 2 days;
After the first Pfizer vaccine, the patient kept feeling dizzy and almost fainting.  After the third day, she actually fainted so she went to the hospital.  She had a high temperature and arrhythmia.  She saw the cardiologist and stayed at the hospital for about 13 hours.  She mentioned she was supposed to see a cardiologist a year ago for passing out, but she never did.
tingling sensation all over the body, when symptoms got worse I went at Spectrum 'medical here in my hometown Nurse Practitioner thought I had a covid vaccine allergy, so she prescribe me Pepcid 40mg and Zyrtec, which developed in a worse side effect, I started to have panic attacks and low blood presure, the crisis still are happening now every single day even though i cut the medication by myself. then went to visit the doctor again and she order a complete list of blood work. Everything apparently  came out normal, but I am suffering for trembling , sweating, cold hands and feet a few times per day. As of now she referred me to a neurologists, they are trying to set up an appointment in this upcoming week,
Pt called to let us know that approx 6 hrs after shot he experienced chills, nausea, diarrhea, fat "bad" arm swelling & discomfort.
Large swelling and redness at injection site. Tiredness, chills, muscle ache.
Within 30 seconds after the vaccine was administered, patient complained of lightheadedness.  Then after one minute, patient was disoriented and started experiencing a seizure.  Immediately 911 was called and a nurse practitioner was called from the Clinic that was next to the pharmacy. Paramedics came to the pharmacy and stabilized patient.  Patient was advised to visit hospital because he appeared very weak.
Pt called pharmacy to report a baseball sized lump on left arm, fever of 101 degrees on 12/23, 103 degrees on 12/25, redness to left elbow. Pt had to go to ER visit on 12/27/16 very early in morning. Diagnosed with cellulitis, goes from left side of arm to right 1 inch radius of injection site extends vertical to about 5 inches vertical of injection site.
HYPOTENSION 12/5/2022 BACTEREMIA  ACUTE RESPIRATORY FAILURE 12/12/2022 BACTEREMIA        HYPOTENSION 12/5/2022 DM 2 W RENAL MANIFESTATION  ACUTE RESPIRATORY FAILURE 12/12/2022 DM 2 W RENAL MANIFESTATION
COVID-19; Strong bitter taste in mouth, sometimes metallic; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DYSGEUSIA (Strong bitter taste in mouth, sometimes metallic) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    No Medical History information was reported.   On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 1:00 PM, the patient experienced DYSGEUSIA (Strong bitter taste in mouth, sometimes metallic). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and DYSGEUSIA (Strong bitter taste in mouth, sometimes metallic) had not resolved.            No Concomitant medication was reported Device Date was reported as 13-May-2022 Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was reported with no onset date; hence latency cannot be assessed. It was reported that the patient received Paxlovid (ritonavir) as COVID-19 treatment, approximately 9 months after the third dose of mRNA-1273 vaccine. No details of primary doses were provided. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was reported with no onset date; hence latency cannot be assessed. It was reported that the patient received Paxlovid (ritonavir) as COVID-19 treatment, approximately 9 months after the third dose of mRNA-1273 vaccine. No details of primary doses were provided. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
She started to get headaches and just over all ill feeling. Her cramps are unbearable.
After receiving the first vaccine I was okay for a few days, then two weeks later I started to have tendinous in my ears and after the third week I saw the doctor and they did a hearing test, and it came back with slight hearing loss. To this day it is still there.
On 7-24-2022, I had a sore throat. The following morning I had the sniffles. On 7-26, I used a home COVID-19 test with negative results. On 7-27, I tested positive with a home COVID-19 test. I contacted my primary care physician on 7-27 thru their internet portal. She responded back on 7-29 thru the portal and told me to take aspirin or TYLENOL for fever (don't know if I ever had one) and drink a lot of non caffeinated fluids. She did not order any medications or tests. I tested negative on 8-6-2022 with a home COVID-19 test. I am reporting a breakthrough case of COVID-19.
COVID; COVID; This is a spontaneous report from a contactable consumer reporting same events under the same suspect product for 3 patients. This is the first of 3 reports. A patient of unspecified age and gender received unknown dose number of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that 3 people died from COVID after getting Pfizer's Vaccine. Three (3) individuals had the Pfizer's shot and died from COVID. The patient died on an unspecified date. It was not reported if an autopsy was performed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101441264 same reporter/drug/event, different patient;US-PFIZER INC-202101441268 same reporter/drug/event, different patient; Reported Cause(s) of Death: COVID; COVID