chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE CHRONIC PAIN; CAN BARELY MOVE; HEALTH SEVERELY DECLINED; SEVERE MIGRAINES; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced health severely declined. On MAY-2021, the patient experienced severe migraines. On an unspecified date, the patient experienced severe chronic pain, and can barely move. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Healthy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the health severely declined, severe migraines, severe chronic pain and can barely move was not reported. This report was non-serious.
pt recv vax 24JUN98 & 25JUN98 had sz activity x 2;
Information has been received from a licensed practical nurse concerning a 65 year old female who on 13-JUL-2007 was vaccinated with a dose of PNEUMOVAX 23.  On 13-JUL-2007 the patient developed swelling, itching, redness and tenderness at the injection site.  Unspecified medical attention was sought and it was noted that five days after the vaccination the patient still had a 20 centimeter circle of redness around the injection site.  The patient was treated with BENADRYL and KEFLEX.  At the time of the report the patient was recovering from swelling, itching, tenderness at the injection site, and a 20 centimeter circle of redness around the injection site.  Additional information has been requested.
Information has been received from a certified medical assistant (C.M.A.) concerning an 82-year-old female with a history of breast cancer, osteoporosis, hernia, a ruptured gallbladder and a phenobartibal allergy, who on 10-Nov-2006 was vaccinated subcutaneously with a "0.6 ml" dos of varicella-zoster virus vaccine live (lot#652925/0621F). Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR), warfarin sodium (COUMADIN), multivitamins (unspecified), albuterol sulfate (PROVENTIL), montelukast sodium and atenolol (TENORMIN). On 11-Nov-2006 the patient developed an injection site reaction characterized as itchy and hot to the touch at the injection site. Unspecified medical attention was sought, no laboratory or diagnostic studies were performed. A cold compress was applied and reportedly "helped a little". She also took diphenhydramine hydrochloride (BENADRYL) in the night to help her sleep. On the morning of 13-Nov-2006, the affected area was the size of a silver dollar. A lot check of this vaccine was requested. At the time of this report, the patient had not recovered. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency.  Additional information has been requested.
Pain, swelling, lump near site of injection.  redness, hot to touch.  Patient seen in office 08/25/2006.  Received a shot of Rocephin 1 gram.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 68 year old male. Initial information was processed along with additional information received on 07-FEB-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: leukemia. The patient received ibrutinib (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for leukemia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient not able to develop antibodies to covid 19 vaccine after receiving Imbruvica for leukemia. (suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s, and ibrutinib was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216156; Sender's Comments: V0.20220211225-covid-19 vaccine ad26.cov2.s -Suspected immunological vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY, SPECIAL SITUATIONS  20220211225-Ibrutinib-Suspected immunological vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Coughing up blood; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 25Feb2021 (Batch/lot number not reported), as dose number unknown, single, for COVID-19 immunisation. Relevant medical history was not reported. There were no concomitant medications (the reporter was refraining from giving the patient some of the patient's medications). On 25Feb2021 (Thursday), the patient received Pfizer COVID-19 Vaccine and did not have any problems. On 28Feb2021, the patient was coughing up blood. This only happened twice. The reporter was wondering if there was something the patient should do. The reporter looked up the fact sheet and didn't see coughing up blood as one of the side effects. The reporter was a little confused. The reporter was not looking for a treatment plan. The reporter was refraining from giving the patient some of the patient's medications because the reporter does not know how it will interact or if it was related to the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received shot in the morning, in afternoon felt a little dizzy then had stomach pain and diarrhea, at night only sore arm. The following day I had severe body aches and extreme fatigue. Felt bad for a few days.
Severe hormonal side effects including ovarian issues, hormonal induced panic attacks and sudden abnormal menstrual cycle
HEAD ACHE; CHILLS; FEVER; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced head ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and head ache on APR-2021. This report was non-serious.
Initial unsolicited report received from a consumer (patient's mother) on 18 December 2015. This case involves a six-month-old male patient who was vaccinated with a dose of DTAP (batch number, route and site of administration were not reported) on 22 June 2015. The patient's medical history of illness at time of vaccination and allergies were reported as none, birth defects, medical conditions were not reported. The patient's concomitant medications were not reported. On 22 June 2015, few hours (two to three hours) following the vaccination, the patient had experienced seizure. On the same day, the patient had visited pediatrician. On an unspecified date, two weeks after the first episode of seizure, the patient had experienced another episode of seizures and till date 18 December 2015 the patient had not experienced any further seizures. The patient required ER/doctor visit. Laboratory data and corrective treatment were reported as the patient was evaluated and was treated by the pediatrician. The outcome of the event was unknown. Upon internal review the case was considered as serious because of important medical event seizure. List of documents held by sender: none.
acute pericarditis was diagnosed. Toradol injection was given, followed up by high-dose ibuprofen for 10 days.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. medical history and concurrent conditions were not reported. On 13-APR-2015, the patient was vaccinated with improperly stored PROQUAD lot # K018142, expiration date 10-APR-2016 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information has been requested.
About 20-25 mins after the injection, my leg started to feel like pins and needles. Within a half hour later, it started getting stronger and was the whole foot. I began to feel hot spots on my right foot. I felt like I had a band around my ankle. It felt like when your foot falls asleep. It worked it's way up the back of my knee. The sensation is still present today but the hot spots are not. The pins and needles are still present in varying degrees. Sometimes its strong, sometimes it is light sometimes it is just some of my toes and it comes and goes. I went to my employee clinic who said it was not due to the vaccine. They sent me to my chiropractor who said there was nothing he could see. I went to my doctor who said it was indeed a symptom. I recently went to a new GYN and she did some blood work. She now has me seeing a rheumatologist.
Mom reports yesterday she thought he had a fever and gave a fever reducing medicine.  States he woke during middle of night c/o headache and blurry vision.  She had him go back to sleep. Woke this am with fever and abdominal pain. Mom brought patient back to this health dept where he received his vaccines on 1/6/2016-HPV9, Hep B, and Tdap.  Child doubled over holding abdomen, fever of 103.1, complained of headache and right groin pain. History of Sickle Cell Disease and I encouraged mom to bring to Urgent care or Emergency room now for medical treatment.  Mom without transportation.  States she can have family member take them.  Declined 911 service.  Child continue to moan and hold abdomen.  Could not stand up without support and severe abdominal pain.  Family member arrived and assisted to vehicle via wheelchair, mom reports they are bringing to ER now at 1125 am on 1/8/2016. Advised mom to call this nurse with update as soon as she is able later today.
Soreness (L) shoulder 1-2 weeks s/p vaccination then followed by "nerve pains". Pains/weakness of (L) tricep muscle progressively worsening over several months until presented to clinic on 2/14/2011. Atrophy of (L) tricep muscle. Sent to Dr for EMG studies.
pt recvd vax & w/in 2-3 hrs pt had urticarial rash to upper body involving face & head & neck; no resp or CV sxs, seen in ER & tx DPH; swelling, erythemia subsided over 2-3 days; @ site of DTP had erythema also;
Within 24 hours I ended up in the hospital! Muscles so painful I couldn't move! This happened a VERY long time ago, but I wanted you to have record of my Adverse Reaction. I ended up being hospitalized twice (had a relapse after the first hospital stay). After what seemed like EVERY test in the book, my "illness" (vaccine reaction) was labeled "blood poisoning". Well, yes, my blood was poisoned!!  My kidneys were also affected. My parents did not report this, as at that time it was unknown how or even it was possible to do so. I was a totally healthy child until my mother took me in for that damn flu shot!  Guessing my body did sustain some kind of permanent damage. I did almost die, though, at the time.  I don't know the exact type of influenza shot it was (you didn't give an option for that).
1st dose 3 years ago, 2nd 09Feb2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 9S252, expiry date 18th June 2024) for prophylaxis.   Previously administered products included Shingrix  (received first dose 3 years ago).   On 9th February 2023, the patient received the 2nd dose of Shingrix. On 9th February 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: No specific  date for first dose was reported. The reporter consented to follow-up via email. Additional supportive information: The patient received second dose of Shingirx later than the recommended interval, which led to lengthening of vaccine schedule.
30min p/vax diff breathing, hives, +itching, nasal congestion tx w/DPH, pred;improve w/tx;
No adverse reaction.  Wrong vaccine given.  Child (2yrs old) who was unvaccinated was given Moderna Bivalant vaccine for ages 6m-5 years 0.2 ml pink cap with yellow label and should have received a 0.25 ml dose of Blue cap with gray border.
Patient has soreness on left arm spreading from site of administration and back of shoulder. Pain is precipitated in the front with movement. Symptoms have presented from date of injection until present time. Patient took ibuprofen and acetaminophen for relief and it did not help.
On 5/9, I experienced extreme swelling in my ankles and feet. I figured it was due to excess walking. It continued and persisted into the next day into an edema. I had a ultrasound done of my legs to check for blood clots. I did not have any. I also had developed a cough that I could not get rid of. I went to many doctors. Through the summer, in July, I developed iritis in my left eye and then a week later in my right eye. I went to an ER, then to their ophthalmologist who put me on steroid eyedrops which helped resolve it. I had a bronchoscopy which determined I have sarcoidosis. All of these symptoms might have been triggered by the vaccine or it could be coincidental. The day after the 2nd dose, I was taking 2-3 hour naps but still able to sleep throughout the entire night. A few days after that, I was back to normal. I also had an endoscopy done. I asked my gastro doctor if the acid reflux could be related to the cough which he said no. The only thing that has helped the cough is prednisone, which I am currently weaning off of.
I had no reaction to the first shot , except sore arm for one day.  After the 2nd shot, the next day I developed a high fever (103) and chills.  I called urgent care that evening to see how to bring the fever down.  They told me that was my body building antibodies.  The fever "broke" later that night.  I never have gotten rid of the chills.  I did not see a doctor for this reaction. During this time, not exactly sure of the dates, the cardiologist started me on a new medicine - Verapamil.   I thought the chills might be from the medicine.  She reduced the dosage due to low heart rate, and I'm still taking the medicine.   I now have a rash on my side and on my left thigh, which is blotchy, red, and itchy.  I do not know if these reactions are from the medicine or from the vaccine, but I suspect it is the Moderna vaccine.  The chills are mostly centered in my legs.  They are not letting up.  I have not seen my doctor about the rash yet.  I have had the rash for a couple of weeks, trying to get rid of it myself.
Reports having URI/ILI symptoms 9/15/21. She described her symptoms and intermittent productive cough and mild shortness of breath. She also notes diarrhea for about 1 week with decreased appetite. She then tested positive for COVID-19 on 9/18/21 and reports she has been progressively gotten worse in terms of overall weakness, shortness of breath, cough, and diarrhea. In the ED, she was found to be hypoxic on room air (87%). CXR showed RLL infiltrate and she is being admitted for further evaluation and management of respiratory failure, CAP, and COVID-19 symptomatic breakthrough infection. Of note, the patient received 2 doses of Moderna's mRNA vaccines earlier this year as part of DPS vaccine rollout.
Patient is a 82 y.o. male who was transferred from emergency department for further evaluation and management of weakness due to COVID-19 infection. The patient initially presented there with extreme weakness that started 1 month ago. The patient was brought the ED today via EMS due to extreme weakness and recent UTI. He has had repeated visits to the ED for the past few days with diagnoses of pleural effusions and a UTI. He had been given an antibiotic as an outpatient treatment but was recently changed to keflex. In the room, the patient further complained of having the shakes and having generalized weakness for 1 month. The patient is COVID-19 vaccinated. He denied any nausea, vomiting, diarrhea, or headaches. He did note some mild fever and chills. The patient also noted a recent stent placement.  He was started on oxygen 2L and dexamethasone on 9/16/2021.  The oxygen was weaned off on 9/17/2021.  Patient is still hospitalized at this time.
On day 18 after immunization she began having L arm pain, L elbow swelling, HA,, body aches, and fever, Tmax 103F.
1st night, chills fatigue 2nd night fatigue, soreness in right arm elbow, hard to lift that arm
About two months after receiving my second shot of the Pfizer vaccine series, I began to experience new symptoms that I had never experienced before. Previously I had always been a very healthy (exercise 3-5x/week, don't eat red meat, try to eat mostly whole foods) person with no illnesses or chronic conditions.  Thus I noticed the onset of these new symptoms right away. What began with sharp shoulder pain on one side soon radiated to both shoulders and back. I was unable to lift either arm and had extreme difficulty and pain getting out of bed. Then the balls of my feet also began to give me excruciating pain that I had never felt before. After a couple weeks of trying to figure the source of the pain with doctor visits and referrals I started noticing swelling in the joints of both my hands and feet along with extreme fatigue. After being referred to a rheumatologist and a series of lab exams, it was concluded that I had Sjogren's disease, a chronic autoimmune disorder. I have since then made changes to my diet including going dairy free and gluten free which has helped with the management of my symptoms. I have also been prescribed hydroxychloroquine, which I have started taking daily since beginning of July.
Red rash at injection site that has grown to about two inches in diameter. Lumpy, hard, warm to the touch, and very itchy. Slight tenderness at the site.
This spontaneous report was received from a medical assistant regarding a 7 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 25-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
patient was out walking and when she came back into the house she sat down at the table and her legs suddenly had severe pain. The Fire District was called at 1754 pm,. Patient went to the hospital, and they found a large blood clot in her leg.
patient stated that a rash appeared around the injection site on 2/12/2021 - rash is red and itchy
patient tested positive for COVID 1 week after vaccination; patient tested positive for COVID 1 week after vaccination; This is a spontaneous report from a contactable physician (patient's wife). This physician reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 21Dec2020, single dose, for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient tested positive for COVID on 28Dec2020 (1 week after vaccination). Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Woke up to chills, then fever developed, up to 100.8. Fever/chills/body aches/headache lasted until the evening of 1/12. Felt miserable
Patient experienced syncopy within 15 to 30 seconds after vaccine (pfizer ) administration next patient was unable to respond noticed gargling but couldnt speak I administered an epipen and within seconds responded and alert . EMT/Perimedics came and brought her to  hospital.
Mild fever, chills, mild headache, loss of appetite, muscle pain all over body.
Student complained of dizziness 25 minutes after receiving intranasal H1N1 vaccine. T-99.0 after receiving vaccine. Denies any complaints prior to intranasal vaccine. BP 120/65, P=100. Allowed to rest for 30 minutes-states that she is still dizzy. Parent contacted to pick student up.
Hot/cold flashes, full body muscle ache, tightness in chest, nausea, and slight dizziness beginning ~6 hours after injection.   Fever peaked 24 hrs after injection.
Adult living facility, doctor, pharmacist unaware patient previously vaccinated 11/24/2014. Called doctor who ordered the vaccination.
After vaccine administration patient has pain at injection site; This is a spontaneous case, initially received from nurse via Company (reference number: SEQ19-07511) on 18-Dec-2019, concerning an adult patient of an unknown gender. The patient was between 40 and 60 years old.  The patient's medical history was not provided.   The patient's concomitant medications were not provided.  On 17-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) for influenza prophylaxis.  On the same day, after vaccination, the patient experienced pain at vaccination site. It was reported that the patient was referred to health care professional, but further details were not provided. The patient did not experience any other adverse reaction.  At the time of initial reporting, the event of vaccination site pain was not resolved.  The case was assessed as non-serious.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  This case is linked to cases 201907370 and 201907372 (due to the same reporter).  Company comment: The event of vaccination site pain is assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The event of vaccination site pain was assessed as related to Flucelvax Quadrivalent.