chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days after shot had Sciatica for a week (Muscle relaxer and pain killer) 15 days after shot got Bells Palsy lasting 2 days (Anti Viral medicine and Prednisone) 33 days later had tremors and could barely walk. 38 days hands and feet numb 42 days after shot in hospital with Gillian Barre Syndrom
GOUT (TOE PAIN); This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and muscle pain, and other pre-existing medical conditions included patient does not drinks soda, drinks a lot of water, was physically fit and active. patient thinks that patient shouldn't be having gout. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205B21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced  gout (toe pain).  On 12-JUL-2021, Laboratory data included: Uric acid (NR: not provided) More than twice than it should be. Normal is 4 and subject had a 9.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gout (toe pain). This report was non-serious. This case, from the same reporter is linked to 20210741152.
Initial episode occurred 5/1/99. Patient awakened from sleep screaming. Legs noted to be red and warm to touch. The entire right leg and the left leg mid-calf distal. The screaming lasted 10 minutes. The redness subsided but purple spots remained. The parents brought the infant to the Emergency Room. The examination revealed an afebrile, alert smiling infant. He was well-hydrated and moving both lower extremities well. Good groin and pedal pulses were palpated and confirmed with hand-held doppler. Toes revealed 4 sec capillary refill. The ventral surfaces of the lower extremities revealed diffuse petecchiae, involving the entire right leg and mid-calf left leg. No other ecchymotic areas were noted. Left elbow revealed an eczematous rash otherwise the remaining skin was clear of rash. Firm non-fluctuant nodules were noted on the anterior thighs at the immunization sites. The nodules were tender but the remaining portion was non-tender. The remainder of the infants e am was normal. Enclosed are the infants lab results. In the following week, the infant had three more episodes, 1-5/2/99 and - 5/6/99. One episode was witnesses in the clinic. The infant started with crying, his lower body from umbilicus to toes symmetrically turned mottled and cyanotic, the left groin pulse was normal. The duration of mottling was 3-5 minutes and 2-3 sec capillary refill was noted on the sole of the foot. After cessation of crying, hyperemia of the lower extremities, about 10 minutes in duration, was noted. The episodes after 5/1/999 did not result in petecchiae. The parents did not notice any further events until a brief episode after an insect bite on 5/30/99. The patient was seen by a pediatric cardiologist on 5/5/99. A doppler ultrasound was performed of the lower extremity vasculature and it was read as normal. The report is enclosed. The patient was seen on 6/4/99 and noted to be in good health. Family history is negative for vasculitis and autoimmune disease. Antenatal history is remarkable for mother having gestational diabetes. She received Isulin and Prosac during prenancy.
Woke up the next morning with intense nausea and fatigue. The nausea resolved ~3 hours later after eating a small amount of food. 6/10 pain in the injection site throughout the entire day (2/5/2021) requiring 2-3 doses of ibuprofen for the pain to be tolerable. These symptoms resolved by the next morning (2/6/2021).
Received 2nd booster on 6/20/22 at 1 PM. At 4:30 PM I felt my heart beating very hard. I took a Resting Heart Rate reading of 71 which for my age is average.  I noticed in the evening the heart was still beating hard. When I went to bed is when I felt the palpitations and fluctuations. They were quite strong - felt like they were in my throat. Kept me up all night and I was very worried. Considered going to ER. Along with heart issue was a very severe headache which had me worried perhaps my blood pressure as rising??   When I got out of bed around 7 AM on 6/21/22 the palpitations were still there.  Since I was up and about I didn't feel them as much. Had no appetite, still had incredible headache. About 1:30 the palpitations were much weaker . By 6:00 PM I could confidently say the palpitations were gone. Still had head ache and forced myself to eat. Food made headache feel better. By 9 PM I went to bed and no headache and no palpitations.
Client received Pfizer Dose 1 after receiving Janssen on 03/07/2021. Client attempted to receive Pfizer Dose 2 on 08/07/21. Client was informed that she cannot complete her Pfizer vaccination series because of her previous Janssen vaccination. Client attested that she did not have any adverse reaction to her Pfizer Dose 1.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both arms/rash is patches like/rash is spreading) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced RASH (rash on both arms/rash is patches like/rash is spreading). At the time of the report, RASH (rash on both arms/rash is patches like/rash is spreading) outcome was unknown. No relevant concomitant medications were reported. No treatment details were reported. This case was linked to MOD-2021-022193 (Patient Link).
felt very weak and tired; felt very weak and tired; body aches; Nausea; Chills; headache; swollen lymphnode under clavicle; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: BW0170) via an unspecified route of administration in the left arm on 23Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Apr2021, the next day of the second shot, the patient felt very weak, tired, had body aches, nausea and chills. The next couple of days, the patient had a headache and also seemed to have a swollen lymph node under her clavicle. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt very weak and tired, body aches, nausea, chills , headache and swollen lymph node under clavicle were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
a patient who is 23 years old received two doses of GARDASIL at 18 years old in 2015; No additional AEs; This spontaneous report was received from a medical assistant referring to a currently 23-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not reported.   In 2015 (also reported as at 18 years old), the patient was vaccinated with the two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (frequency, lot #, expiry date were unknown; does, strength, anatomical location, and route of administration were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event (no adverse event).
I was given PPSV Pneumonia and Flu shot at same time in same arm. No previous reaction to flu shot, first time with PPSV shot. Within one hour dizziness, nausea, tingling and numbness in arm and hand. Next day (11/29) had to stay home from work, very painful to move arm, cannot dress/undress, very limited movement of arm due to pain (even with 800mg ibuprofen) tingling and numbness in arm/hand dissipating. Very pale, dizzy. Day 3 (11/30) woke with similar symptoms and now with welts all around injection site. Still extreme pain in arm, general feeling of sickness feeling like passing out, tingling and numbness in arm/hand returning. Went to facility (11/30) given pain killers and antibiotics, hoping for the best.
FACE SWELLING, HEART PALPITATIONS, EXTREME FATIGUE, HEADACHES.
Tinnitus developed suddenly.  Very loud, very constant. No hearing loss noticed.  No previous experience with tinnitus.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9266), in right arm and on 08Mar2021 as dose 2, single (Lot number: EL9264) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Dec2021 as dose 3 (booster), single (Lot number: 045J21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Anti-viral details: For COVID 19, patient was treated with Paxlovid. Treatment start date was 08Jul2022 and treatment stop date was 13Jul2022.  No follow-up attempts are possible. No further information is expected.
inj site sore x6 days; sweaty, achy, HA, sore throat, fever, 101.4 fatigue, foggy head x6 days  Narrative:
RECVD ENGERIX-B(IN RT DELTOID)ON 11-30-89 AS 2ND DOSE IN SERIES OF HEP B VAXS.WITHIN 24 HRS INJECTION SITE BECAME HOT RED ITCHY INDURATED;8-10 cm OF SWELLING,PRURITUS. AREA TREATED WITH COLD COMPRESS.RESOLVED IN 7 DAYS.
Generalized fever, aches, nausea, fatigue starting ~12 hours from shit and lasting ~36 hours.  Mild pain at injection site.
DTaP given on 04/26/05 at approx 3:30PM. Child began to c/o pain at injection site on 04/27/05 at approx 3:30PM. By around 5PM the injection site started swelling, red, hot. Mother applied cold compresses that night. Took child to Dr this morning. Dx with cellulitis-put on antibiotics.
pt recvd vax & broke out in red raised rash; no resp distress; lt arm rash faded w/in 5 min raised, small bumps remain on arm; raised bumps;
Patient died of a cerebral hemorrhage on 3/15/2021 at 11:30 AM.
I started feeling discomfort in bladder area the night after I got the Moderna vaccine along with frequent urination. I called my doctor and went to get a urine culture done. I am still waiting for the doctor?s response. I was perfectly fine before I got the vaccine.
Originally tested antigen positive on 08Aug, symptoms began on 06Aug; Originally tested antigen positive on 08Aug, symptoms began on 06Aug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Originally tested antigen positive on 08Aug, symptoms began on 06Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive, notes: Originally tested antigen positive on 8Aug; (13Aug2022) Negative, notes: tested Negative on both August 13 and 15; (15Aug2022) Negative, notes: tested Negative on both August 13 and 15; (16Aug2022) Positive, notes: Tested positive again via antigen test on 16Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Anti-viral details reported as Product (Paxlovid) for Covid-19 treatment from 08Aug2022 to 12Aug2022.Tested positive again via antigen test on 16Aug2022. Initially tested Negative on both 13Aug and 15 after 5 day dose of Paxlovid. Originally tested antigen positive on 8Aug, symptoms began on 6Aug. Took Paxlovid from 8-12Aug as directed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PREMATURE BIRTH; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate of an unspecified race and ethnicity. The patient's mother was enrolled in a non-company sponsored study: COVID 19 Vaccines Pregnancy Exposure Registry. The patient's weight, height, and medical history were not reported. On 09-AUG-2021, The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number was not reported and expiry: Unknown) dose was not reported, 1 total administered for COVID-19 immunisation. The drug start period and drug last period 81 days. The batch number was not reported and has been requested. No concomitant medications were reported. 09-AUG-2021, the patient experienced fetal exposure during pregnancy. On 29-OCT-2021, the patient experienced premature birth. The reaction first time and last time for  the event premature birth was 82 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 29-OCT-2021, and the outcome of premature birth was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and premature birth, and fetal exposure during pregnancy as not related. Company causality between covid-19 vaccine ad26.cov2.s, and premature birth was related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20211148570.; Sender's Comments: V0: 20220809205-covid-19 vaccine ad26.cov2.s-Premature birth. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.  20220809205-covid-19 vaccine ad26.cov2.s-fetal exposure during pregnancy. 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. Therefore, this event(s) is considered not related.
Flu-like symptoms. Chills, vomiting, headache, muscle pain. Was seen at Urgent Care on 10/10/16. Diagnosed with intractable headache. Coarse of sickness lasted until 10/12/2016.
This case was reported by a healthcare professional and described the occurrence of local reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified allergic reaction local reaction. At the time of reporting the outcome of the event was unspecified. The nurse reporting the event stated that out of 240 doses of FLULAVAL that she has administered, about 10 people have reported a local reaction. There were no additional details.
1:45 pm pt. received DEPO, HepA, GARDASIL and flu - five minutes later (R) arm was red around injection site. Pt. reported throat feeling like it was closing up. 1:51 pm - administered BENADRYL 25mg po. 2:00 pm - (L) arm started turning red where flu was given. Pt. started c/o mouth itching also redness noted at (R) breast. BENADRYL administered 25mg po again. 2:10 pm - c/o hands itching and hurting, states throat feels it is slowly opening. 2:14 pm - redness resolved (L) arm and redness at (R) breast slowly resolving, redness red arm decreasing. 2:25 pm states hands no longer itching, states throat completely open now. 2:50 pm states hands no longer hurting, throat remains open redness all areas resolved. 3 pm pt. remains stable. 3:15 pm - pt remains stable. Pt. instructed to call MD if any further problems noted and to call 911 if throat starts closing up or has difficulty breathing. Pt voiced understanding. 4:05 pm pt. discharged in stable condition with no further complaints with ride. Vital signs were checked after 15 minutes and were WNL and at no time was pt. in respiratory distress.
I developed Diffuse large B cell Lymphoma in the armpit of that arm right under the vaccination site. And it is the only site showing this
About 45 minutes after the vaccine patient reported starting to feel crummy, as the day went on symptom got worse, blurred vision, overall feeling of weakness, dizziness, feeling like it was hard to breathe, pale skin, heart thumping in chest and temples.
I was experiencing extreme fatigue, underarm pain, weight fluctuation, ear ringing, headache, rapid heartbeat, night sweats, upper and lower extremities pain, muscle weakness in my legs, and memory loss/brain fog during a span of months after receiving my booster. Everything gradually got worse over time, especially the rapid heartbeat and heart palpitations even during resting. I don't have the stamina I once had; I can no longer run or exercise like I once was able to do. I went from working out 5-6 times a week to now I've only worked out 5-6 times in the last year since receiving the booster. I contacted my doctor in regards to the symptoms I've had and was referred to a rheumatologist. I've had several bloodwork tests completed to try to determine a proper diagnosis for what's happening. I've been hospitalized twice in August and September 2022 as well as December 2022; I had to go the emergency room because the pain and tightness had gotten so bad in my chest, I couldn't breathe. My blood pressure has constantly spiked since then as well. I'm just frustrated with everything that's been happening and no proper diagnosis.
The patient received the 1st dose of the Moderna covid vaccine. After receiving the vaccine Approximately 5 minutes after receiving the vaccine she felt like her left hand/arm was heavy. She began to feel lightheaded and weak. This caused her to eventually have a syncopal episode in which she complained of dizziness, some jerking motions, some lightheadedness and then some chest pain. She felt like it was hard to get a deep breath. An EKG was done which was unremarkable, fingerstick blood sugar was 108. An IV was placed in her right arm and she received 1 liter of Lactated Ringers solution in addition to orange juice and crackers. She started to feel better after approximately 1 hour and was sent home.  On 4/1/2021
Caller states he has received four Pfizer vaccines, tested positive for Covid on Saturday/ they would do a Covid test and it came back positive; Caller states he has received four Pfizer vaccines, tested positive for Covid on Saturday/ they would do a Covid test and it came back positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller states he has received four Pfizer vaccines, tested positive for Covid on Saturday/ they would do a Covid test and it came back positive". The events "caller states he has received four pfizer vaccines, tested positive for covid on saturday/ they would do a covid test and it came back positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021215783 Same Reporter/Patient/Drug, Diferent AE/Vaccine Dose;
rash under location of bandage, as well as proximally on shoulder.  Pruritic.  Was on face, but by 3/11, had cleared from face and was starting to improve.  No facial swelling, SOB, D, or other systemic reactions.
Pain, swelling; soft tissue fluid collection per ultrasound. Possible abscess. Treated with oral antibiotics x 7 days; TYLENOL; Ibuprofen; NORCO.
Patient reported pain at injection site that has become severe since flu shot 10 days prior. It has become progressively worse and spread down his arm some and also into his neck. I advised him to see a physician for proper diagnosis. Upon further research it appears he may be experiencing brachial neuritis. (No swelling/redness at site).
pt recv vax 27MAR97 & same day 1-2PM pt started getting fever;4Pm T103.4 APAP given, sponges bath given;7-8PM consult w/MD temp taken every 102hr T104 max;sz activity w/eye rolled back, stiffening-straightening observed x1;redness & swell
COVID test: PCR showed positive; COVID test: PCR showed positive; High blood pressure; dose 1 on 16Jun2021 and dose 2 on 29Jun2021; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2, dose 2 via an unspecified route of administration, administered in arm left on 29Jun2021 15:00 as single dose, dose 1 via an unspecified route of administration, administered in arm left on 16Jun2021 15:00 as single dose, both at the age of 32-year-old for COVID-19 immunisation. Medical history reported as none. No Known allergies. There were no concomitant medications. There was no other vaccine in four weeks. The patient was not diagnosed COVID prior vaccination. The patient experienced high blood pressure (life threatening) on 01Jul2021 16:00 with outcome of recovered in 2021, the event (high blood pressure) resulted in physician office visit. No treatment received for the event (high blood pressure). The patient had COVID test: PCR showed positive on 28Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure: high on 01Jul2021 16:00, COVID test: PCR: positive (Nasal Swab) on 28Jul2021.  The lot number for BNT162B2, was not provided and will be requested during follow up.