chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had a blood clot in her heart and it killed her; Initial information received on 21-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had a blood clot in her heart and it killed her while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer with unknown dose lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the had a blood clot in her heart and it killed her (intracardiac thrombus) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) patient had a blood clot in her heart and it killed her.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient had a blood clot in her heart and it killed her).  At time of reporting, the outcome was Fatal for the event patient had a blood clot in her heart and it killed her. No autopsy was done. The cause of death was reported as Cardiac thrombosis.; Sender's Comments: Sanofi company comment dated 24-Feb-2022: This case involves an unknown age female patient who had a blood clot in her heart and it killed her while receiving vaccine INFLUENZA VACCINE. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: blood clot in her heart
Left upper arm is tender, swollen and erythematous. Right is warmer on touch.
This spontaneous report as received from a registered pharmacist refers to a 79 year old male patient with no drug reactions or allergies. On 03-OCT-2012, the patient was vaccinated with a dose of PNEUMOVAX23, 0.5 ml, intramuscular (lot# reported as H009826, expiration date 11-FEB-2014). No other co-suspects were reported. Concomitant medications included: FLUZONE. On 03-OCT-2012, the patient developed tenderness at the injection site after receiving a dose of PNEUMOVAX23. There was no treatment given for tenderness at the injection site. No laboratory tests were performed. The patient's outcome of tenderness at the injection site was unknown. The patient sought medical attention, called the pharmacist. The relatedness for tenderness at the injection site was not reported for PNEUMOVAX23. Additional information is not expected.
No additional AE reported; Expired MMR II vaccine was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients pertinent medical history and drug reactions or allergies were not reported. The concomitant therapies included sterile diluent.  On 28-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T001213 and expiration date reported as 12-JAN-2022), 0.5 milliliter for prophylaxis (expired product administered). The vaccine did not have any temperature excursions. No additional AE reported. No PQC.
hair fell out in copious amounts p/vax of all 3doses of hep b vax;
Two vaccines (Daptacel and ActHIB) were administered at my daughter's routine 6 month well visit around noon on 5/1/2020. The following morning (5/2/2020) she woke up with a rash all over her body that was especially severe around her armpits, torso, and groin. I spoke with the triage nurse and was told to monitor the reaction and give Tylenol and/or Benadryl if needed, or to call back for high fever or refusal to eat. The rash spread and got worse as the day progressed, becoming a darker red color and raised, like welts. The following morning (5/3/2020), the rash was slightly better on her chest and stomach, but still concentrated around her groin, back, arms, and legs. On the morning of 5/4/2020 the rash was much better and mostly cleared. The doctor confirmed that this was a vaccine reaction and agreed that it should be reported to VAERS.
This 73 year old female patient received the Covid shot on  3/26/21  died on 5/4/21.
Patient presented with erythema at injection site. Referred to local MD - site was enlarged and red with diffuse redness surrounding the center red spot. Looked more like a skin infection.
Chills    24 hours Vomiting     an hour about 3 or 4 times Fever       7 hours Arm Pain  still hurts
patient states that about 2 days after shot bruising occurred on the lower part of the upper arm (not at or around injection site )
Potential SIRVA. Patient experiencing left shoulder pain and reduced range of motion. Recommended patient take NSAID therapy and if symptoms continue to get worse to seek treatment by a physician. Patient did see a nurse practitioner and started a 3 day course of prednisone 30 mg.
t102, swollen glands on neck, red swollen scrotum, glands in genital area also swollen;
Extreme itchiness all over body (like hives, but without the hives presenting on the skin)
Extreme itching covering entire body following Tdap vaccination. Treated self with oral Benadryl. Onset occurred 1 day after injection with increase of itching the following day. No otherside effects.
reported "feeling awful all over"; This case was reported by a physician via sales rep and described the occurrence of feels awful in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient felt awful all over after receiving first dose of shingrix.
01/10/2022: Event occurred after 2nd vaccine. 83-year-old male with past medical history of hypertension and lung disease being worked up for COPD who presents the emergency department for concerns of dry mouth, cough, decrease in taste as well as body aches.  He states that he has productive cough with yellow sputum.  He notes that he was tested positive approximate 1 week ago.  Denies any significant fevers, abdominal pain.  He denies any diarrhea or blood in stool. hypoxic on room air upon arrival 88%.  Remains in hospital on 01/12/2022.  Remdesivir started 1/10/2022. Decadron 6 mg daily.  4 L nasal cannula
Suspected Vaccination failure; shingles 2 times AFTER MY SHINGLES VACCINE; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had the shingles, before the 1st shingles shot).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had shingles 4 times, once in between the 1st and 2nd shot of the vaccine and 2 times after his/her shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided. For tolerance of 1st dose refer case US2021AMR176133.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176133:Same reporter
pt recv vax 31JUL98 & 14AUG98 pt devel greater than 50 vesicular & vesiculopapular skin lesions described as a diffuse rash starting posterior auricular, fever of 100.5, chills, muscle aches & joint pain;
Left Deltoid area edema, warmth, and tenderness to palpitation within 24 hours of administration.
suspected vaccination failure; I have shingles all my life/i took all shots/nothing helps/they pop out any time.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The patient was 74-year-old at the time of reporting. The age at vaccination was not reported. The patient reported that, he/she had shingles all him/her life. After receiving all shots of Shingles vaccine, nothing helped, and the patient got shingles.  The patient stated that, shingles popped out any time. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
A few minutes after the immunization of Gardasil, child became extremely dizzy and faint, with no loss of consciousness.  Assisted to floor and given fluids.  Able to walk out of office 15 minutes after onset.
I got a runny nose for 2 days and I took molnupiravir.
Bradycardia, hypotension Diaphoresis, pallor, visual disturbances  - Patient treated for hypotension via IV/Fluid administration. - Patient transported to Medical Center
The pt's mother reports that both injection sites got enlarged, red, warm to touch and painful. Also the pt had a fever. Symptoms lasted for five days. Mother used Tylenol and compresses and the pt's symptoms resolved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 30Nov2021, stop date: 01Jan2023; METOPROLOL, start date: 30Nov2021; BUPROPION, start date: 31Dec2020.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Other medication in 2 weeks. Patient had no Known Allergies. Patient received COVID 19 Treatment of Paxlovid from 01Jan2023 to 06Jan2023  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to a 58 years old female patient who on 03-DEC-2012, was vaccinated with an expired dose of ZOSTAVAX 0.65 ml subcutaneously in left arm (lot # 671004/0729AA, Exp: 17-AUG-2012). No adverse effects reported. Additional information has been requested.
Twenty minutes after receiving influenza vaccine pt. presented with a tight feeling in her throat; mild lip swelling and redness and swelling at injection site (right deltoid).
small flare up of hives; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation. On an unspecified date, after second dose of vaccine, patient had a small flare up of hives. This was not confirmed if it was caused by vaccine or not. The outcome of the event was unknown.  Information about batch/Lot number has been requested.
5/24 59y.o. female with a PMH of CAD s/p stents, HTN, HLD, DM type 2, hypothyroidism, restless leg syndrome, and anxiety/depression who presents with Left lower extremity erythema and pain for last few days which has been progressively getting worse despite PO antibiotics and flu like symptoms .
I had sent in my first report after my 1st vaccine and hope you received it by certified mail.  The blood work done after my 1st vaccine showed an elevated liver count.  The test was redone 03-23-21, and the liver count is normal.    My right arm started to hurt around 7:00 pm after getting the 2nd vaccine  shot between 11-12 am 3/26/21.  There had been no vaccine 3-25-21, so I was called to come in , and I said I'd be there as the same time before .  Due to minor swelling and continued pain, initially heat helped and then to a cold compress .  I took 1 Tylenol, as I had began slight headache.  During the (night or) early morning around 2:00 am , I awoke chilled to the bone until around 4:30 am. I stayed in bed  Saturday morning  (the 37th of March until 11: am due to my body being achey, weak, foggy brain,  left side of my kidney hurt, noticed I was urinating less the next few days, my upper stomach to the left middle throbbed/ached, had weak muscles and bone, with a stiff neck, as my whole body felt I had been run over by a truck.  At 5 pm the same day (3-37-21) I felt faint, just as weak or weaker with kidney (left side) continued to hurt, as well as, the upper part of my stomach (middle) and under my breastbone.  I stayed in bed all day Sunday, 03-28-21   My bowels have been affected - off + on. (03-29-2021)  Because of the Emergency Care visits and test ,  my family dr. wanted me to come in. She was sort of dismissive about there being anything to do when on gets the covid-19 virus.           The Emergency Care Dr. (Privacy) went over symptoms, gave me 4 pages of information and had done the blood work, strep test because my throat seemed like it was blistering,  my chest hurt and with a lot of coughin.  for weeks,  he did a chest x-ray.  After 5 covid test and all coming back negative , the blood work showed I had had the virus but my antibodies due to my low immune system , tried to fight it off. The dr says I'll be one of the Long Haulers , so I do not know what symptoms  I'll have to come. I just feel tired and listless with all of this going on with my whole body system. Continues where I had gotten my inhaler filled (never had to ever use it after 10 years of allergy shots - everyone here seems to have allergies but over the years I have not been affected until after the 1st shot.)  I only heard a little wheezing at night at bedtime and sleep on 2 pillows for elevation and due to acid reflux.     My kidneys and bowels continue to be affected. The fibromyalgia 1 nervous system had affected both. Now, the kidneys go to much or not enough, and my bowles are constipation to much diarreah.     (3-30-21)  Woke up and just not feeling well all over. I am a optimistic person and do well in public or during this pandemic.  I always find much to do around the house, but it takes me days to do a single task.  I do crossword puzzles daily to keep mentally active. I walk around my yard and pull a few weeds,  plant a flower or two, but know my body well to know the symptoms will be around as a LONG HAULER. Thanks.
I had my shot over a week ago and today the injection site has gotten red, swollen and itchy.  It continues to get larger.   I am planning to call the doctor tomorrow if it's not better.
Mother phoned on 5/4/12 to report the following: patient received Menactra 5/2/12 approx 3pm (not exact). That eve pt had numbness and tingling in all extremities and legs got stiff feeling like couldn't move. About 4hrs later got headache which resolved then returned 5/4/12 AM. Next day (5/3/12) pt went to school nurse with c/o back of rt leg numbness. No other c/o. no swelling or redness at injection site. Aebrile. Discussed with Dr. Since symptoms had resolved, observe for now. If recurrent, see immmediately.
The pt's mother noted about 4 hours after the vaccination. Pt's lower extremities were ntoed to be swollen and red. Petechial rash in lower legs below knee.
During vaccine appointment, 17 yo client was given Fluzone shot mistakenly when vaccine was not indicated. Client had already received Fluzone vaccine earlier in the season and was up to date. Guardian was notified by phone. Father and client had no concerns at time of call.
Heart beat felt in throat. Began  occasionally after 2nd shot.. Increased frequency after each shot.
Developed HA, low grade fever (99), mild nausea, tiredness. 2 days after vaccine. 6 days after vaccine- 2x2" area induration, redness, warm to touch at injection site.
07/28/2021 At approx 10 min after injection at 1715, client stated she "was feeling dizzy and like she was going to faint." Approx 1716, client was talking w/RN and appeared to exhibit vasovagal s/sx's, i.e. dizziness.   Client stiffened for approx 2 -3 seconds, appeared to immediately faint in closed vehicle (drive up clinic) woke up after apprx 3 seconds, w/no loss of urination, stated she was slightly disoriented, and w/i 5 seconds oriented X4.   Approx 1717, client was able to answer questions and stated "I feel so much better, back to normal.  I have no medical conditions, no hx of seizures, and on no medications."  Client later stated she had fainted in the past w/injections, stated she hadn't drunk much water during day.  Environmental temp was in 90's, outdoors.   At approx 1725 client was able to walk w/o difficulty or dizziness to restroom and continued to be monitored in observation until 30 min after time of injection. Client stated she felt normal and fine to drive.  Client stated she was planning to go to store to pick up dinner for herself & daughter.  RN advised client if she felt any s/sx?s as previously experienced to safely pull off road immediately.  RN explained s/sx?s of allergic reaction to client and daughter and instructed client?s daughter to call 9-1-1 if client appears to have fainted, showing any signs as previous episode, any type allergic reaction, or in need of emergency medical care.
The day after my second vaccine I experienced extreme fatigue, lack of appetite, and nausea, lasting  all day. No fever and no soreness in my arm, and I did not contact my doctor. A few days later I noticed a firm lump or swollen lymph gland in my left armpit. After a few days it gradually began to improve over a 10 day to 2 week period.  I am reporting in order to assist vaccine knowledge.
Pt had a syncopal episode @1152 while being observed in waiting area. The pt slipped off chair onto the ground, did not sustain any injuries. Physician onsite indicated that it may have been a Vagal response. The pt has history of fainting related to anxiety.
Pt did not respond following series of 3 vax.  An addit. dose was given 16Jan91.
abdominal pain, nausea, diarrhea,  vomiting for several hours which are not listed under the side effects!   Shame on the manufacturer!
Lasted approximately 36 Hours.  I had cold chills through the night.  When I awoke on 4/2/21 I didn't want to get up.  When I got up felt foggy and groggy, kind of a strange feeling and had a headache.  Really didn't want to do anything.  Around 9:00 AM on 4/2/21 I took 2 ibuprofen and felt better  until around 2:00 PM.   Around 2:00 PM I  just ached all over in my wrist, lower back,  just felt terrible.  I couldn't  seems to get warm. I was chilled all day.  I took 2 more ibuprofen on 4/2 at 7:30 PM and went to bed.  Sleep all through the night without waking and got up at on 4/3/21 at 6:45 AM and felt like a new person
both of her shoulders had knives in them(pain); This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (both of her shoulders had knives in them(pain)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 004M20a) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included MELOXICAM (MOBIC), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ESTRADIOL (ESTROGEN), COLECALCIFEROL (VITAMIN D 3), ASCORBIC ACID (VITAMIN C ACID), FISH OIL and CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced ARTHRALGIA (both of her shoulders had knives in them(pain)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (both of her shoulders had knives in them(pain)) outcome was unknown.            Treatment Medicines include Tylenol and Mobic that patient takes for Arthritis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Post vaccine pt became dizzy and felt lightheaded. Pt transported to med obs via wc. Pt reports feeling better after lying down on stretcher. Vitals obtained and monitored.  Pt had no complaints of chest pain. Pt had no complaints of SOB. Pt released at 14:02. Vitals as follows: 1350 LYING BP 112/75 HR 95 RR 18 SpO2 100% 1400 SITTING BP 116/64 HR 92 RR 18 SpO2 98%
After 4mon & 6mon. sets of shots he developed constant waking & screaming every hour. Lasting for about 2 months.