chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 12 year old daughter with sulfonamide allergy who on 23-JUL-2008 was vaccinated with a dose of VARIVAX (lot number, injection site and route not reported), a dose of Tetanus Toxoid and a dose of Meningococcal vaccine (unspecified) (manufacturer not provided). On 24-JUL-2008 the patient experienced allergic reaction characterized by a 5 inch welt, fever of 101.3 and sore throat. Unspecified medical attention was sought. At the time of reporting, the patient's events persisted. Follow-up information was received from the patient's mother which reported that the welt on the patient's leg went down however she still had a sore throat and a stomach ache. No outcome was reported regarding the patient's fever. Additional information information is not expected.
I initially had fatigue that night. I got up the next morning and thought I had a bad round of gout. My right big toe was swollen and painful and I couldn't bend it. I took Tylenol and it helped. By the end of the day my toe was better. After that, All my joints started to hurt all over! It would rotate through my body. Its in my elbow and left knee today, but before that it was in my ankles.
red marks on the shoulder where the injection was given; big red mark and a red mark right under it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red marks on the shoulder where the injection was given) and ERYTHEMA (big red mark and a red mark right under it) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043-B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included MULTIVITAMINS [VITAMINS NOS], PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (red marks on the shoulder where the injection was given) and ERYTHEMA (big red mark and a red mark right under it). At the time of the report, VACCINATION SITE ERYTHEMA (red marks on the shoulder where the injection was given) and ERYTHEMA (big red mark and a red mark right under it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I am leaning towards calcified blood clots, however that has not been confirmed yet; felt a bump under my skin in my left arm/more painful bumps had appeared; This is a spontaneous report from a contactable healthcare professional. A 37-year-old female patient received the second dose of BNT162B2 (lot number: EN6205), via an unspecified route of administration in arm left on 18Mar2021 14:00 at single dose for COVID-19 immunisation. Medical history included known allergies: Strawberries. Concomitant medications included muscle relaxers, and anti-inflammatory. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of BNT162B2 (lot number: EN6200) on 24Feb2021 14:00 in left arm for COVID-19 immunization. Shortly after, maybe a week, after getting the second dose patient experienced a bump under her skin in the left arm on 01Apr2021 16:00. Over the last few weeks more painful bumps had appeared. Most of these hard lumps were in her left hand. She had one that she knew of in her right hand. Patient met with her PC doctor and the doctor sent her for X rays and ultrasound. Every tech and doctor that had looked at her hands had never seen anything like this. These masses had been confirmed with the ultrasound and more were found during that visit. Patient was moving forward with getting a magnetic resonance imaging (MRI) of her hands. Patient was leaning towards calcified blood clots (01Apr2021 16:00), however that had not been confirmed yet. Adverse events result in doctor or other healthcare professional office/clinic visit. Nasal swab on 24Apr2021 was negative. Treatment was received for the adverse events. Outcome of the events was not resolved.  Information about lot/batch number was available. Further information was expected.; Sender's Comments: Based on temporal association, a causal association between the reported event and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.  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 RAs, Ethics Committees, and investigators, as appropriate.
Hives noted to increase. Also redness at MMR/Varicella injection site with small amount of hives and swelling noted.
Information has been received from a physician concerning her niece who was vaccinated with the first dose of GARDASIL on an unspecified date. The patient had an adverse event (details of the adverse event unspecified by reporter). The father of the child called the physician and asked if she should receive additional doses. The physician stated not to continue the series. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
After my booster, I started experiencing tinnitus in my right ear. I didn?t immediately associate the ringing with the vaccine. It started getting worse over the next several months. I noticed that my hearing seemed to be worse as well. I finally went to the ENT and my hearing test indicated low frequency hearing loss in my right ear. An MRI revealed no anomalies so the hearing loss is acute and unexplained. I can?t prove it but I strongly believe it is associated with the vaccine. I?ve seen articles from Covid researchers that suspect a link between hearing loss and the vaccine in some people.
After nurse gave injection patient felt intensely hot, and felt like she was going to pass out.  Patient taken to EMS room via wheelchair.  Pt drank sips of water.
Very sore arm x 2-3 days after vaccine, resolved. 4 days after vaccine - cough, horrible headaches, body aches, no energy (fatigue) x 9-10 days. I was unable to work, slept a lot. Took Migraine medications that helped lessen headache pain (Zomig nasal spray, Sumatriptan, Eletriptan) and Acetaminophen and Ibuprofen for body aches.
Pt. has MS and received Flu shot in (RA). The arm was very bruised and pain level was very high - 10 on scale 1-10.
41 yo M hx of OSA, HTN. DVT Right leg: Progressive worsening pain in right thigh began 3 days post-vaccination w/ J&J, progressed to severe pain on day 10. Patient alerted us to symptoms on 8/4/21. Exam: temp: 99.1, HR 101, BP 145/85, O2 97%. >400lbs obese man with severe bilateral lower extremity edema, bilateral varicose veins visible lower extremities. (-) Homan's sign. No initial erythema/redness, no warmth throughout. Gait: ambulated with visible mild limp favoring left LE. 8/10/21 ultrasound demonstrated large right lower extremity thrombus extending into femoral junction. ER/hospital admission 8/10/21: Echocardiogram: right heart strain with right ventricular diastolic dysfunction, pulmonary hypertension. CT Chest angiogram: 8/10/21: bilateral pulmonary emboli with saddle embolism.  He was admitted with full dose anticoagulation with heparin x 24 hours, then with Lovenox 40mg subcutaneous q 12 hours x 3 days, then eventually transitioned to long term apixaban (Eliquis) 5mg bid long term.  VIR consulted: Thrombolysis was deferred since he was hemodynamically stable with echocardiogram. Now with chronic LE edema, compression stockings, and has returned to activities daily living/work. He had significant risk factors of OSA, HTN, morbid obesity and reported he was very sedentary during the week of his vaccine.
Redness and soreness at the injection site. Covered most of the back of her arm. Happened in about 24 hours.
got sick; Initial information was received on 13-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown demographics patient who got sick 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 (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "patient used to get free flu shots at work and got sick anyway. So patient had stopped."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.
Fever,coughing,sob,severe weakness over 4day perios,went into resp distress,unable to raise up became no strength
Pt called to complain of pain and swelling at injection site and she is unable to raise her arm above her head.
10 min. after-extreme swollen glands in throat sick for 2 days. 13 days later, Dr. found shingles in cornea of right eye and a circle on forehead. Allergic to valacyclovir. Became very ill. Had to be on prednisone for 10 days. Shingles went to roof of mouth, then to under tongue. Lower tongue and gums. Then appeared on stomach.
I was diagnosed with bells palsy in 2005.  Full recovery with small amount of paralysis remaining on left side of face (left corner upper lip).  About 5 days after vaccine noted chewing differently.  Eight day after vaccine new paralysis on left side of face now extending to entire jaw area and upper and lower lip.  New paralysis on right side of face.  Eye won't blink, eye brows won't raise, unable to puff jaw and area next to noise won't move.  Twelve days after vaccine minimal improvementlater
16DEC92 began having rash on stomach, back & shoulder fine bumps w/itching; 17DEC92 began having nausea & vomiting; no fever was seen by MD who said had stomach virus; also exp diarrhea & sore throat;
Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency
Patient developed painful ulcers on her vaginal opening on both the right & left labia. The ulcers were first noticed the morning of January 10th, and had increased in severity by 4:30PM in the afternoon the same day. Initial cultures done for viral or bacterial infection came back negative & it was determined the ulcers were the result of an autoimmune response. Dr prescribed Clobetasol 0.05% ointment be applied twice daily for a week, then once daily for the second week. Patient experienced severe paint and burning that made urination difficult. We followed up with her pediatrician on Thursday January 13th. Dr prescribed a 5 day regiment of Prednisone  & ordered bloodwork. All bloodwork came back normal and mono was also ruled out. Patient was hardly able to urinate by the evening of January 13th. We followed up with her gynecologist the morning of January 14th. It was necessary to insert a catheter to relieve her bladder of urine. The Dr ordered topical lidocaine for use before urinating to reduce pain & burning, silver sulfadiazine cream for application to the affected area, fluconazole, & cefdinir.
Error - administered high dose flu vaccine instead of regular flu vaccine. Stiff, sore, painful arm.
Patient received the vaccine and felt fine after the injection.  Went to the waiting area for observation and a few minutes later fainted.  Patient claims everything went black just before the incident.  After a few seconds he came to, was alert, knew where he was, knew his name and why he was there.  He mentioned he felt like his chest was hurting and requested that EMS be called. EMS took over care for him testing for Heart issues, blood pressure, etc.
Within a week of getting the 2nd Covid shot I started having vertigo; Dizziness; Extreme ringing in my left ear; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 59-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 at 12:00 (Lot number: EW0150) at the age of 59 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6207, Anatomical site: left arm, Administration time: 12:00), administration date: 11Mar2021 when the patient was 59 years old for COVID-19 immunisation.  The following information was reported: VERTIGO (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Within a week of getting the 2nd Covid shot I started having vertigo"; DIZZINESS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Dizziness"; TINNITUS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Extreme ringing in my left ear". Relevant laboratory tests and procedures are available in the appropriate section. The events within a week of getting the 2nd Covid shot I started having vertigo, dizziness and extreme ringing in my left ear resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of vertigo, dizziness and tinnitus.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received thyroid medication as treatment for the reported events. Since the vaccination, the patient had been tested for COVID-19 and the result was negative. The patient also received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 at 12:00 (Lot number: FF2587) at the age of 59 years as dose 3, booster single for COVID-19 immunisation.
This spontaneous report as received from a Register Nurse refers to a female patient of 1 day old. On 27-JUN-2014 at 10:41 the patient was vaccinated with an improperly stored RECOMBIVAX HB lot # J012520, first dose, intramuscular. No adverse events were reported. Vaccine storage temperature dipped to 0-1 degree in 18 different episodes between 14-MAY-2014 and 21-JUL-2014 according to min and max temperature. They knew that when all recorded temperatures checked were within 2-8 degrees. This is one of several reports received from the same source. Additional information is not expected, all follow ups requested to complete the case were received.
Temperature 100 (anally) and local right thigh swelling on site of vaccination. Next day: slept slight longer than usual, decreased appetite and very very calm. Right arm jerking, head twitched few seconds. ER. Glucoma with fully recovered within one day.
evening of vax temp averaged 100.5 & sl redness of leg was noted; pt cried non-stop form 8PM-MN, occasionally holding breath;next day, pt was eating & acting fine;mom stated that the coloring around the mouth & nose was pale-looking
SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath. This report was non-serious.
My first 3 doses were Moderna. I started getting symptoms of cold symptoms, congestion and sinus pressure headache. My wife tested positive then the next day, I tested and it was positive. I initially thought it was a sinus infection. My symptoms just stayed with sinus pressure and congestion, they were mild. My symptoms lasted for 4 days. I did a telehealth and was prescribed Paxlovid.
It was sent for low pressure on 02/12/2021 to the Hospital Medical Center. He died of respiratory arrest.
This spontaneous report as received from a nurse refers to one patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. The VARIVAX was stored in temperature of -12.45 degree Celsius (C) for 30 minutes. There was previous temperature excursion reported: -9 C to 8 C for 3 hours 30 minutes and -14 C to -10 C for 4 hours 45 minutes. A digital data logger was involved. No product quality complaint was involved.
Case number PHEH2014US024296, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 51 years old male patient. Past medical history and concomitant medication were not reported. His previous vaccinations (unspecified) were well tolerated.  The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in left deltoid on 12 Nov 2014. The nurse reported that before vaccination, the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hours and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Patient received the shot and immediately started complaining about pain from the shot. Moments after, he was complaining about itchiness on arm, and throat soreness. His throat soreness subsided, but he was still in pain for about 15 minutes. We gave cold compress and eventually the patient felt better.  He felt uncomfortable, as he didn't want to get the itchiness to come back, so we gave him some benadryl to take home.
My arm was sore immediately. By 9AM sunday I  started feeling bad. At approximately 3pm  Full body aches, fever, swollen neck, swollen face, chills, pain all over. Like I had been hit by a car. Around 3pm Sunday all I could do was lay in bed wrapped in a blanket.  Monday 08/23/2021 my mom took me to urgent care.  Dr said I was having severe allergic reaction that it should go away in 24 to 48 hours and was told to not get the second shot
04/20/22 vaccination, 05/11/2022 Had a runny nose with cough. 05/16/2022 @ home COVID test; POS; 05/17/2022 tele-med w/ dr. PCR test; POS
Pain on left side of body.  Started at left heel, leg, hip, shoulder and neck.  Pain settled in both shoulders and neck concentrating on the left side.  Slight fever two evenings, 99.6 and 100.4
OBSTRUCTIVE SLEEP APNEA 4/18/2023 UTERINE FIBROIDS
loss of  voice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: APHONIA (non-serious), outcome "unknown", described as "loss of voice".  Additional Information: Additional Information: Consumer wants to know if losing voice is a side effect of the Pfizer-BioNTech Covid-19 Vaccine. She said this happened after the 1st dose of the vaccine. I told the consumer that there is no information about losing voice associated with the Pfizer-BioNTech Covid-19 Vaccine. I referred the consumer to her HCP for more guidance. This is a spontaneous report from a Pfizer- sponsored program  .A contactable female consumer (Patient) reported for herself that: It was unknown if the reporter a healthcare professional. : It was unknown if reporter's contact information available to you or a sub- contracted party. Reporter the prescribing was health care professional. Caller mentioned that after her first dose she experienced loss of voice. Caller would like to know if loss of voice is one of the side effects of the vaccine. Call transferred and manually created an adverse event form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscle aches; threw upa  number of times.; stomach issues; This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, 1 day after receiving Shingrix, the patient experienced muscle pain, vomiting and stomach discomfort. On an unknown date, the outcome of the muscle pain, vomiting and stomach discomfort were recovered/resolved.   It was unknown if the reporter considered the muscle pain, vomiting and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by the husband of the patient. The age at the vaccination was not reported. The patient received Shingrix and in early February and had aching the following day. Prior to her aching she threw up many times. However, two days after the onset of the side effects the patient was completely free of the aches and stomach issues.  This case linked with US2020AMR070653, reported by same reporter (husband's case). The patient had just returned from a trip to where she had gone for a vacation. The reporter concern was that she may have picked up the coronavirus on trip. She had not been tested. If she did pick up the virus, shingrix shot might have played a key role in killing the virus. Might be worth a little research.
Vaccine had been thawed 1/08/21, had expired before giving not caught until after given