chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nauseous; weak; no appetite; numbness on the skin of my arms and legs; I was post Ictal for 2+ hours; seizures/having 2 non epileptic seizures; dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Batch/lot number: EK5730), intramuscularly on 28Dec2020 07:45 AM at right arm, at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient received vaccine around 7:45 AM. Within 2 minutes she felt extremely dizzy and lightheaded on 28Dec2020. She sat down and drank some Gatorade and took deep breaths. The feelings persisted 5 minutes later. She then woke up after having 2 non epileptic seizures while still in 15m waiting period, (This included posturing and color change) a rapid response was called and she was taken to the ER. She was post Ictal for 2+ hours. Dizzy and nauseous, weak and no appetite for the rest of the day. She had no history of epilepsy. She also have numbness on the skin of my arms and legs within 24 hours of the vaccine. Onset date of all events (except dizzy and lightheaded) was reported as 28Dec2020 08:00AM. Treatment fluids, Zofran was received for all events. All event resulted in emergency room. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered with sequel.; Sender's Comments: A possible contributory effect of suspect BNT162BW on reported seizures cannot be excluded.  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.
Rash appeared around patient's mouth and nose within 24 hrs of receiving her first dose of the Moderna COVID vaccine.  Patient applied topical hydrocortisone with minimal improvement.  Rash resolved over the course of the following week with resulting dry, flaky skin.
Within 5 minutes of administering the vaccine, the patient states she was having some shortness of breath but not to the point of needing an Epi-pen.  We asked her to stay for more monitoring and gave her some water. At 545pm her symptoms did not improve and we administered 50mg of liquid benadryl.  She asked to go to the emergency room but did not want us to call an ambulance but we called the ambulance at 6pm.  EMS arrived at 6:15 and took her vitals, pulse ox and stated this is a milder reaction and it was up to her to go with them to the hospital.  She refused to go with EMS.  When we followed up with her the next day, she stated she did go to the hospital and was monitored overnight.  They discovered it was because her blood sugar levels were high leading to symptoms.
Excessive swelling of injection site right hip. Swollen down buttocks and into labia majora. Prescription given. Orapred 15mg 1 tsp bid.
Patient called County Health Department 12/12/13. Return call per RN on 12/12/13. Patient stated that shot was given in the right deltoid and became a little sore that day. States the right arm was still sore 3-4 weeks later. States he did not seek medical attention because he did not have a doctor. States right arm still sore today, 12/12/13. RN called County Health Department who coordinated a visit for this patient with the nurse practitioner on duty. RN called patient to inform him of the scheduled visit to County Health Department so someone could look at his arm.  Patient said that he was out of town and he didn't now if he would be able to make it.  RN offered the patient the telephone number so he could call and coordinate a more convenient time according to his schedule so he could see them. Patient said that he already had their number.
Patient developed LE pain bilaterally worse than baseline the day following vaccination as well as diffuse body aches. This progressed to weakness over the next week. He was admitted to the hospital for for inability to ambulate 5 days after vaccination. Patient improved while inpatient on IV pain medication. Physical exam was NOT consistent with gullian barre.
Patient called the Immunization Clinic from her work and approximately 12:45 on 4/27/2010 and stated that around 11:00 that morning she began to feel "itchy" all over.  Pt. states she looked down at her lower arms and noted hives on her left arm.  Pt stated she continued to feel itchy and took Benadryl 25 mg by mouth at approximately 11:05 and noted the hives had spread to the right lower arm.  Patient denied nausea, dysphagia, dyspnea, edema of face/hands, or feeling of impending doom.  Patient sounded alert and oriented to time, place, and person.  Pt was instructed to go to the emergency room.  Patient stated she really didn't want to.  Patient stated this had happened before with a flu shot and she took Benadryl 25 mg every 4 to 6 hours for 72 hours and she felt fine.  She stated she planned on doing that this time too.  Patient was strongly encouraged to go to the nearest E.R. and was intructed on the symptoms, treatment and outcome of anaphylaxis.  Patient verbalized understanding of all information and stated she would go in if it got any worse. Patient again instructed on the importance of seeking medical help and also following up with her primary care provider to see if she needed to get a referral to an allergist for evaluation.  Patient instructed she was not to receive any more immunizations until she saw her medical provider.
I was told to report that I caught Covid and suffered lengthy symptoms despite vaccination.  Beginning around March 4, 2022, I began having extreme fatigue, chest congestion, and painful headache.  I briefly also had nausea and vomited once (more like reflux vomit) that day.  Covid confirmed on March 7, 2022.  It is now March 18, 2022, and I am still suffering with fatigue cycles, chest congestion, headaches, and loss of taste and smell.
The patient was incorrectly given 0.2mls of Pfizer gray cap instead of Pfizer orange cap. Her mother was notified shortly after the shot was given, and advised to observe for any adverse effects.
Spontaneous nose bleeding when she woke up. It lasted around 20 minutes. I called 911 because never happened before and I got scared .
I was feeling unwell on 01/05/2022, burning sinus, run down, fatigue and burning sensation in evening, and flushed sinus with Urgent Care saline solution . We to be fine and awoke 4 hours later with 104 temperature, went into the Urgent Care. At 07AM. Had to call into work and adhered to the COVID portal call. Symptoms worsen and was received antibiotics and was able to return home and was in bed for 4-5 days of rest. Heavy sweating 4-5 and Blood oxygen level  88 dipping  for a few weeks and just go it under control with Pulmonary specialist. I received a positive COVID 01/06/2022 was an issue. 1500 steps reduced and going to the ER hospital for evaluation for CT and Blood Clots , Pulmonologist and changed medication out.
The patients mother called the babysitter and the baby was crying from the time the infant took her shots (at 10:45 AM) until 3 PM. No fever. The mother states the baby's cry was between a whiny and a high pitched cry. The PMD said to report the incident.
Pt was admin. FLUZONE HD on 10-16-14 at 11am to 12pm. Pt states around 12am-1am on 10-17-14 had fainted and had nausea/vomiting, dry heaving. Went to hospital ER. ER stated that everything looked OK. Observed for 5 hours then released.
Pt recvd 1st dose of Engerix-B 11AUG92 & next day 12AUG92 pt exp a rash;
N.P. called 11/4/15 6:30pm and stated pt was being treated for pain and loss of mobility in left arm that occurred after receiving flu shot. Patient was receiving PT. Tried following up with patient - no answer. N.P believes pain is due to location of where the shot was given. N.P stated she believed shot was given too high on arm and may have entered bursa. Staff will be reeducated on proper injection technique.
lightheaded/dizzy with some nausea   Also tingling feeling on lips andleft side of face   Headaches  Still going on after 3 weeks
I felt very tired and developed increased palpitations, chest pains, and shortness of breath with exertion I was diagnosed with pericarditis through my cardiologist
Twelve hours after vaccination (1/20/21), left side of tongue felt swollen/dry/tingly. Was able to sleep. In morning (1/21/21), developed same sensation, plus lips and off/on left side of face felt tingly. I am not ruling out anxiety.
Reaction to PNEUMOVAX 23. Pt reporting pain at site of vaccination approx. 7hrs after receiving. The next morning pt's arm was swollen, red w/ hives and unconscious after fainting. EMS responded to pt.
2nd does of vaccine was received Tuesday November 9, 2021.  On Thursday the 11th patient woke up at approximately 3pm and had decreased vision in her right eye.  On Monday November 15th the patient woke up with a minor headache.  When she returned from school at approximately 2:15 the headache had become a migraine, she complained of sinus pressure, nausea, and vomiting.  On Tuesday November 16 the patient complained that the migraine, nausea and pressure was getting worse and vision had not gotten better.  On Wednesday the 17th the patient continued to complain the symptoms were getting worse.  Mother called primary care physician who instructed her to take child to emergency room to rule out blood clots.  Patient arrived in the emergency room where tests were run to rule out blood clots.  Patient was diagnosed with a migraine and conjunctivitis.  Patient followed up with primary care physician on November 22 at 9:45 am.  Patients vision was returning with the use of eye drops.  However, headache and nausea remained.  Patient has noted that it has been difficult to eat or drink due to nausea and headache.  In addition patient complains that she is unable to sleep.
Within 15-20 minutes of receiving the Tdap immunization i started feeling major chest pain, pressure, palpitations (felt like I was having a heart attack) and coughing and wheezing. I immediately call the doctors office and they said I was having a reaction to the shot. The nurse told me to take Benadryl and to go to the ER if I couldn't breathe. I could always breathe and didn?t want to go to the ER because we had brand new insurance with a very high deductible. (My husband lost his job a few month before due to Covid layoffs). I couldn't afford to go to the ER because I got a routine Tdap booster. I spent the next 5 days with extreme heart pain, pressure, palpitations, and discomfort. I was taking Benadryl every 4 hours for 5 days straight. I couldn?t exercise for 2+ months and have had heart discomfort ever since. I have since been diagnosed with a ?Chronic Pericardial Effusion?. I?ve had numerous tests, monitors and blood work done. I haven't been able to lie on my left side at night in almost a year without discomfort. My cardiologist believes that the Tdap is the cause of my chronic pericardial Effusion. I meet with a vaccine induced specialist on November 1st, 2021. I truly feel like I should be reimbursed for financial, physical, and emotional damages by what this immunization has done to me.
FEVER; BODY ACHES; HEADACHE; This spontaneous report received from a parent concerned a female of unspecified age. 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 13:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced body aches. On 12-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, and body aches. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
This spontaneous report was received from a nurse practitioner (also reported as a nurse prescriber) via a company representative and refers to a 60-year-old female patient. The patient's pertinent medical history included colon cancer (unknown date). No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On 19-DEC-2016, the patient was vaccinated with ZOSTAVAX (lot # M034765) (dose, route of administration, injection site and expiration date were not provided). On 21-DEC-2016, the patient complained of "weakness in the lower extremity - paraplegia and urinary retention, which required self catheterization". On the same day, she was hospitalized for these symptoms and discharged on 22-DEC-2016. The outcome of paraplegia was reported as recovered/resolved on an unknown date, as the patient's sensation in the lower extremities was restored and she was using her walker (which she had used prior to this incident). The outcome of urinary retention was not reported. The relatedness between the events of paraplegia and urinary retention and ZOSTAVAX was not provided. Upon internal review, the events of paraplegia and urinary retention were considered to be medically significant. Additional information has been requested.
Patient received expired vaccine. Expiration date: 03/2021  Did not have a reaction or complaint
legs started to swell and she still has swelling around her ankles; legs started to swell and she still has swelling around her ankles; This is a spontaneous report from a contactable consumer (sister) from a sponsored program. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced legs started to swell and she still has swelling around her ankles on an unspecified date two weeks after vaccination. The consumer questioned if it could be lymphedema and the patient never had any type of swelling before. The clinical outcome of legs started to swell and she still has swelling around her ankles was not recovered.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
pt exp redness, swelling & sl pain in area of inj;upon exam pt had 12x10cm spot in lt deltoid area;pt also explained body aches & not feeling well overall;
fever at 100.9 degrees Fahrenheit/around 20 minutes ago from time of call temperature was 101.8 degrees Fahrenheit/100.8 degrees Fahrenheit earlier today; wife zoned out, wasn't concentrating; sluggish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. This consumer (patient's husband) reported for a female patient (reporter's wife).  A 73-year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 11:30 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, tolerated the first Covid 19 vaccine very easy), administration date: Jan2021, for COVID-19 Immunization, reaction(s): "tolerated"; Bnt162b2 (Dose: 2, He reports after the second Covid 19 vaccine he and his wife were both down for the afternoon), administration date: Feb2021, for COVID-19 Immunization, reaction(s): "down for the afternoon". The following information was reported: FEELING ABNORMAL (non-serious) with onset 28Sep2021, outcome "unknown", described as "wife zoned out, wasn't concentrating"; PYREXIA (non-serious) with onset 29Sep2021 10:00, outcome "unknown", described as "fever at 100.9 degrees Fahrenheit/around 20 minutes ago from time of call temperature was 101.8 degrees Fahrenheit/100.8 degrees Fahrenheit earlier today/45 minutes ago from time of this call that her fever was 101.8 degrees Fahrenheit"; SLUGGISHNESS (non-serious) with onset Sep2021, outcome "unknown", described as "sluggish". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter and his wife received the booster dose of the Pfizer Covid-19 vaccine on 28Sep2021 around 11:30 AM after the booster dose his wife became quiet and distant. Several hours later at dinnertime, the wife zoned out, wasn't concentrating, went to bed to sleep it off. This morning around 10 AM, the wife had a fever at 100.9 degrees Fahrenheit, and around 20 minutes ago from time of call her temperature was 101.8 degrees Fahrenheit. Reporter stated that she was still in bed and has only taken a few sips of water. Stated that her temperature earlier today was 100.8 degrees Fahrenheit and around 45 minutes ago from time of this call that her fever was 101.8 degrees Fahrenheit. The wife was very sluggish, will not get out of bed, won't take a sip of water, and did not take her morning medications. Reporter was asking if his wife can take aspirin to bring her fever down? Reported seriousness as unspecified for all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experienced lower back pain and also has a burning sensation to the pan. Also experienced shivers, feeling cold, and increase pain at the injection site
4:30 pm - 12:00am started with Chills, Fever at highest was 102.3, Headache, Heart Palpitations - resting heart rate of 134 bpm spoke with Telemed and referred to local ER Department
Admitted to ER on 2/19/21. CT scan showed two pulmonary embolisms one in each lung.  I'm currently on blood thinners.
received that FLUZONE HD vaccine a week before with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician and consumer/non-health care professional via Company (Reference number- 00790680) and transmitted to Sanofi on 29-Sep-2021.  This case involves a 77-year-old male patient who experienced received that INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] vaccine a week before (inappropriate schedule of product administration)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 20-Sep-2021, the patient received first 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 28-Sep-2021 he also received same second dose of the same vaccine (lot: UJ716AC and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination (inappropriate schedule of product administration).  It was reported "Patient who received two doses of FLUZONE HD within 8 days of each other. First dose was 20Sep2021 and second dose was 28Sep2021. Caller wants to know if there is anything they should do or watch for. The patient did not realize that he received that FLUZONE HD vaccine a week before and the HCP (health care professional) giving the second dose did not see the documentation of the first FLUZONE HD vaccine".  This case was an actual medication error due to inappropriate schedule of vaccine administered (latency: same day)  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Hot injection site; A big huge hive is covering injection site is huge; Itchy injection site; Injection site is red; Swollen injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.     This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot injection site), INJECTION SITE URTICARIA (A big huge hive is covering injection site is huge), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Swollen injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history. ).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), INJECTION SITE URTICARIA (A big huge hive is covering injection site is huge), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE WARMTH (Hot injection site), INJECTION SITE URTICARIA (A big huge hive is covering injection site is huge), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant product use was not provided by the reporter. The treatment was included Benadryl as advise by her pharmacy  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1) Behavior change: very "fussy"/screaming episodes X 5 days started 4/28/10 Wed - 3.30 AM - Woke up screaming within 11 hrs of immunization and improved by 5/2/10 Sunday PM. ?? Abdominal cramps - no temperature noted - 2) Poor feeding: instead of usual 5 oz breast milk/formula every 2 1/2 to 3hrs, decreased to 2 to 3 oz and sometimes refused to feed and continued screaming. Improved by 5/2/2010 Sun PM. 3) Stools offensive odor and looser x 4-5 days, still went every other day some mucus in stool, no blood. Rectal exam negative - bowel sounds active.
Noticed the day after the vaccine. Redness, swollen, feverish to touch, and itching. grew double the size by  Thursday which was two days after  vaccine.  Was seen in urgent care on Friday four days after vaccine. was given an antibiotic and was diagnosed with cellulitis.
Patient reported arm swelling in the arm the vaccine was administered within 15 minutes of getting the vaccine, extending to shoulder, back and fingers. Patient's primary care provider dignosed cellulitis/bursitis and started the patient on anitibiotics. Patient reported feeling better within 24-48 hour of doctor visit.