chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymph nodes on her neck and under her arms were bigger than  half dollars and red as fire/lymph nodes swell; lymph nodes on her neck and under her arms were bigger than half dollars and red as fire; totally lethargic; lost all use of her legs and she could hardly stand up; she couldn''t eat or get up to take care of herself; chest pain; shortness of breath; she couldn''t eat or get up to take care of herself; Diarrhea; dizzy/light headed; throwing up; panic attack; This is a spontaneous report from a contactable consumer (patient).   A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) Dose 3 via an unspecified route of administration, administered in the right arm on 04Oct2021 at 11am (at the age of 79-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 09Jan2021 (Lot Number: EH9899) via an unspecified route of administration, and he second dose of BNT162b2 on 30Jan2021, for COVID-19 immunisation. The patient experienced no side effects/adverse events after these 2 doses. The patient experienced lost all use of her legs and she could hardly stand up on 05Oct2021, totally lethargic on 06Oct2021, lymph nodes on her neck and under her arms were bigger than half dollars and red as fire/lymph nodes swell on 07Oct2021. In Oct2021, she couldn't eat or get up to take care of herself, chest pain, shortness of breath, diarrhea, light headed/dizzy, throwing up, and panic attack. The patient stated that on Monday, 04Oct2021 she got the Pfizer Covid booster. The next day she lost all use of her legs and she could hardly stand up. Caller stated that on Wednesday, 06Oct2021 it was like she was totally lethargic. By Thursday, 07Oct2021, her lymph nodes on her neck and under her arms were bigger than  half dollars and red as fire. She couldn't eat or get up to take care of herself. The patient went to the ER on 09Oct2021 and doctor stood at the end of the bed and told her he was not interested in the lumps on her neck and under her arms, he was concerned about her heart as she was having chest pain and shortness of breath. She told him well it was a panic attack not a heart attack from this booster shot. The patient stated they wanted to do a CT scan with contrast and she did not know about the contrast and she refused and came home. She does not put contrast or nuclear in her body. The patient stated that her blood work and everything at the hospital said she was fine and they would not tell her what was causing the lymph nodes and fire red. The patient stated she was having diarrhea and throwing up. The patient stated she was light headed and dizzy. The patient stated she won't take another booster. States she is afraid to even take the flu shot and will talk to her GP about that. The patient underwent lab tests and procedures which included blood test: normal. The outcome of the events was unknown.   The Lot number for BNT162b2 was not provided and will be requested during follow up.
Pt developed redness, swelling involving (R) upper arm. Initially on lateral aspect. Then developed large hives & swelling involving medial aspect of her (R) arm. No resp. problems. Painful.
1. Fatigue ? day 1 - Tuesday 2. Loss of appetite ? day 1 Tuesday 3. Fever 102.0 ? day 2 - Wednesday 4. Chills ? day 2 - - Wednesday 5. Weak ? day 2 - - Wednesday 6. Non-ambulatory (unusual) ? day 2 - - Wednesday 7. Two emergency service ambulance assessment ? day 2 - - Wednesday 8. Symptoms improved ? day 3  - Thursday 9. Ambulatory  - day 3 - Thursday 10. Symptoms worsened ? day 4 - Friday 11. Chills ? day 4 - Friday 12. Non-ambulatory again ? day 4 - Friday 13. Fever 102.0 ? day 4 - Friday 14. Left side flank pain ? day 4 - Friday 15. CPR and declared decease at home by paramedics - day 5 - Saturday morning @ 1:32am
p/vax pt devel n/v, dizziness & pain in lt arm @ inj site;started approx 1hr p/vax;no ecchymosis or erythema noted @ site;
pt recvd vax in oct90 using material which was past its expiration date;at time of report,no problems noted
headache, lightheadedness, fatigue, and a fever of 100.4 - site of vaccine has a slight redness/tenderness (mom reports mild - consistent with vaccine localized reaction). Sxs have persistent through from 5/16/2021 to 5/18/2021, temperature has slightly improved at 99 with Motrin, but headache/fatigue persisting, and then patient woke 5/18/2021and vomited x 1.  day 3 with slightly elevated temp, persisting headache, fatigue, and new onset sx of vomiting today.  Motrin for fever, fluids, rest, and monitoring at home.
severe asthma; gradually kept getting worse with wheezing; Fluzone High-Dose, patient received had been stored improperly; Initial information received on 08-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 65 years old female patient who experienced severe asthma (asthma) and gradually kept getting worse with wheezing (wheezing), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient stated in the past when she has gotten vaccines the only side effect she can think of was being tired.  On 25-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe asthma (asthma) and gradually kept getting worse with wheezing (wheezing), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also a case of actual medication error due to incorrect product storage. The consumer received a letter form the office that the Fluzone High-Dose she received had been stored improperly; that she was made aware of this on 07-Apr-2020; that the letter stated that he efficacy of the dose but not the safety might be an issue since it was improperly stored.  Other relevant tests were not reported.  Final diagnosis was severe asthma.   Corrective treatment: The consumer reported that the asthma began right away described as not knowing the exact day but soon after the injection; that she gradually kept getting worse with wheezing; that she then went to the clinic and was prescribed Prednisone and a rescue inhaler. Later, she saw pulmonologist and was placed on a 3 month regiment of high dose BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) after the asthma became severe; that she was still on the Symbicort.  The outcome of the event was not reported.  The information on the batch number will not be available for this case.
pt recvd vax;24 hrs later, exp redness, swelling & warmth at the inject site;sxs were tx w/ dph & resolved;
Around 12:00 a.m. I had chills so I took Tylenol. Then at 3:00 a.m. on 3/1/21 I threw up bile a few times. After that I was fine.
Client called facility on 5/5/11 stating complaints of "funny sensation and numbness down left arm, states area where shot was given appears like burned skin patch about 1/4" in diameter."
On Thursday Jan 14, 2021 I got the Singles vaccine as part of my physical - this was around 9am.   Thursday evening I was fine.  Friday morning I had to make some effort to get up. Whole day I was feeling sluggish. By evening I started getting a severe headache and chills. There was no fever. A bit if body ache, especially on the lower back. I took Tylenol and slept early. Had some chills.  Saturday morning was similar with headache and some chills. By mid afternoon I started feeling bit normal but weak.  I was constipated whole day and did not have a bowel movement.   I kept with Tylenol. By Sunday morning, I felt fine except for my sore arm which still hurts. Bowel movement was OK but felt constipated.  Monday I was back to normal except for sore arm.   As of Tuesday morning, while writing this report, only symptom left is sore arm at site of injection but much reduced than 2 days ago.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; THREW UP THREE TO FOUR TIMES OR VOMITING; NAUSEOUS; This spontaneous report received from a patient concerned a 63 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker. The patient had no known allergies and drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included prednisone.  On 07-APR-2021, about four hours later patient got nauseous and threw up three to four times or vomiting then patient was perfectly fine couple of days later. The issue of patient was she on prednisone for eight months. The patient was on prednisone 9-10 milligram at the time of vaccination. On an unspecified date, the patient had antibody test showed suspected immunological vaccine failure. In the patient family nine doctors was their and they suggested to take another vaccine without mentioning that she already had the vaccine. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Low antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from threw up three to four times or vomiting, and nauseous on 10-APR-2021, and the outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint. This case, from the same reporter is linked to 20210901129 and 20210900823.; Sender's Comments: V0: 20210900297-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Within a few days of the shot, I started experiencing leg cramping and a week later, extreme pain in my right calf and behind the knee. I went into the doctor on 11/19/21, and was diagnosed with multiple blood clots in my lower right leg. These were confirmed with an ultrasound. Three days later, on 11/22, I went to the ER with shortness of breath and irregular heart activity - I was diagnosed with multiple pulmonary embolisms in both lungs.  Treatment recommended was anticoagulants and home monitoring, currently one month into recovery.
Patient received 2nd Booster dose and is 49 years and 10 months. Birth date was verified by RN administering vaccine but age was not verified. Patient is not immunocomprimised.  I discovered patient wasn't 50 years old when entering vaccinati9n in the system. Patient was still present and notified.
Patient received his first dose of Monkey Pox vaccine intradermally.  He reported feeling on and off onset of lightheadedness.  He mentioned he has no current health conditions, and the only prescriptions he takes are Truvada and lisinopril.  Vitals: 120/90 , HR: 80, O2 96, R: 16.  Patient felt better after waiting for about half an hour and had someone else drive him home.
I lost a healthy niece in May 22 and she was 41 yrs old and she just dropped dead her autopsy; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (I lost a healthy niece in May 22 and she was 41 yrs old and she just dropped dead her autopsy) in a 41-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 01-May-2022 The patient died on 01-May-2022. The cause of death was not reported. An autopsy was performed, but no results were provided.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient just dropped dead and her autopsy come back undetermined.  No treatment medicine were reported.  Company comment: This spontaneous case reported by a consumer, concerns a 41-year-old female patient with no reported medical history, who met with a fatal outcome (PT: Death). Death occurred unknown days after administration of second dose of mRNA-1273 vaccine. Other details are not available for medical review. An autopsy was performed, however exact cause of death was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 13-Mar-2023: Non-significant follow-up appended; Reported Cause(s) of Death: Undetermined
lasted for 15-20 minutes and went away however she had another episode the next day; pain went from the shoulder over to the center of her chest; Arm was a little sore; Sudden rising neck pain (left neck) that woke her up; pain across her chest; Her heart was beating very fast; Her breathing was affected; Almost as if she was running and trying to catch her breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), NECK PAIN (Sudden rising neck pain (left neck) that woke her up), CHEST PAIN (pain across her chest), HEART RATE INCREASED (Her heart was beating very fast) and DYSPNOEA (Her breathing was affected) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VITAMIN B COMPLEX, LEVOTHYROXINE SODIUM (SYNTHROID) and ESTRADIOL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore), NECK PAIN (Sudden rising neck pain (left neck) that woke her up), CHEST PAIN (pain across her chest), HEART RATE INCREASED (Her heart was beating very fast), DYSPNOEA (Her breathing was affected), DYSPNOEA (Almost as if she was running and trying to catch her breath) and ARTHRALGIA (pain went from the shoulder over to the center of her chest). On 06-Mar-2021, the patient experienced CHEST PAIN (lasted for 15-20 minutes and went away however she had another episode the next day). On 05-Mar-2021, PAIN IN EXTREMITY (Arm was a little sore), NECK PAIN (Sudden rising neck pain (left neck) that woke her up), CHEST PAIN (pain across her chest), HEART RATE INCREASED (Her heart was beating very fast), DYSPNOEA (Her breathing was affected), DYSPNOEA (Almost as if she was running and trying to catch her breath) and ARTHRALGIA (pain went from the shoulder over to the center of her chest) had resolved. On 06-Mar-2021, CHEST PAIN (lasted for 15-20 minutes and went away however she had another episode the next day) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Breakthrough case admission after two doses  Moderna 2/17/21 Lot# 015M20A;  Moderna 3/17/21 Lot# 030A21A
Patient presents to ER with cough, congestion, headache and sinus pressure x1 week.  She also reports a low grade fever.
Moderna vaccine (NDC 80777-0273-98) lot 039D21A and GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna no need to repeat the dose.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included TYLENOL. On 2nd April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 3rd April 2019, the patient experienced dizziness, headache, weakness, heart racing, nausea, rash, chills, diarrhea, lower extremities weakness of, mental concentration difficult, pulse increased and fever. On an unknown date, the outcome of the injection site pain, weakness, lower extremities weakness of and mental concentration difficult were not recovered/not resolved and the outcome of the dizziness, headache, heart racing, nausea, rash, chills, diarrhea, pulse increased and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, dizziness, headache, weakness, heart racing, nausea, rash, chills, diarrhea, lower extremities weakness of, mental concentration difficult, pulse increased and fever to be related to SHINGRIX. Additional details were reported as follows: The patient was vaccinated on left arm, intramuscularly. The patient planned to follow-up with his physician on an unknown date.
Soreness and tenderness in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness and tenderness in his arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 day history of SOB with exertion with worsening chest pain leading to presentation at the Medical Center ED and subsequent admission for post-vaccinia myopericarditis.
Rash at injection site over a week after shot. It was mostly gone 36 hrs later. No itching. Arm was also sore and swollen for about 3 days after shot.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 4 years old patient (gender not reported) who received a dose of vaccine IPOL and along with a dose of PENTACEL (lot number not reported) via unknown route in unknown administration site on 28-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Report on 8OCT91; pt recvd DTP/OPV/HIB on 27AUG91 in the morning; afternoon p/shot was given pt turned white & head flopped back; pt was limp; lasted only a few seconds & then pt was fine; Pt was given DT on 8OCT91 & had not problems;
Passed out; Distorted face; Dizziness; Could not feel arms and legs; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support from a contactable registered nurse. A female (reporter's friend) patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient received the COVID-19 Vaccine. After the first dose, she had a distorted face, passed out, dizziness and could not feel arms and legs. The outcome of events was unknown.  The lot number for the vaccine BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Loss of consciousness and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I have been experiencing horrible hot headaches that began 05/04/2022, difficulty waking due to numbness in my feet progressing up my legs, extreme fatigue, no appetite, and overall not feeling well. I had not had any health issues prior to being vaccinated, but it caused a stroke and vasculitis. These symptoms have not resolved, and have worsened. The pain in my feet is excruciating and I feel like I'm being tortured at night. The doctor has referred me to a neurologist for further care, and I am waiting on an appointment. The pharmacist had shown me the highlighted changes made to the Dose 4 Pfizer second booster.
1.  within few days of pfizer dose 1, noticeable exacerbation of serious dry eye disease (eg noticeably dryer at night and/or earlier in day), no change in baseline dry eye regimen and/or other health status.  when i saw local ophthalmologist about 10 days later, she objectively noted increased dryness and decreased meibomian gland expression during ipl.  in response to my concern that s/sx were vaccine-related, she was initially silent;  when i asked her again, she disclosed that she had not yet been vaccinated bc ophthalmologists were seeing post-vax AEs that they could not explain.  multiple ophthalmologists and/or treating physicians concurred re: vaccine causation (eg "makes sense," "don't know if temporary or permanent", also seeing post-vax uveitis, cornea transplant rejection, etc); one ophthalmologist recommended steroid drops for post-vax dry eye exacerbation.  treating physicians were supportive of deferring dose 2 until i actually felt comfortable doing so.  received dose 2 only after one ophthalmologist recommended pre-emptive steroids.    2.  menstrual changes - increase in amount/duration of menstrual flow for few cycles.   3.  vaccine hesitancy and post-vaccination regret - arising from censorship and lack of empathy from colleagues (and pt groups) re: post-vax AE, cdc/ govt lack of credibility (eg cdc itself tried to tell me that post-vax "serious" adverse events included fever, nausea, etc). and refusal to actually understand and/or directly address substantive reasons for vaccine hesitancy, open/debatable scientific questions, etc.
Severe chilling with shakes began approximately 13 hours after injection and lasted approximately 5-7 hours.  Then I experienced some sweating.  During all of this I kept checking my temperature and it varied between 96.8 and 97.6 degrees.  When these symptoms stopped I was then extremely fatigued and lost any form of appetite although I kept drinking water throughout the day.  By early evening, around 7pm, all symptoms were gone except the fatigue but when I woke up the next morning everything felt normal.