chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health professional refers to a patient of unknown demographics. The patient was reported to be indicated for ZOSTAVAX but received (Oka/Merck) in error on 04-MAR-2015. No adverse experience has been reported. No product quality complaint (PQC) was involved. Reporter considered the event as not related to (Oka/Merck) VARIVAX. Additional information has been requested.
Pounding headache; This is a spontaneous reporter from a non-contactable consumer. A 59-year-old male patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via unspecified route of administration on 04Mar2021 at 10:00(at the age of 59-years-old) as a single dose for COVID-19immunisation. The patient medical history was not reported. The patient had no history of allergies. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 04Mar2021 the patient experienced pounding headache. The patient did not received any treatment. The outcome of the event is not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My arm felt sore, but not as bad as the first dose.  The next day I developed a severe headache, very weak and shaky, and terrible chest pain. by evening on the day after the shot I had trouble breathing. I went to bed expecting to die because I could barely breathe. The next morning I felt better than ever! I went to work. I'm afraid to get the booster shot now.
Patient was brought back to office 25-30 minutes after injection given complaining that his chest hurt. Patient exhibiting welts, wheezing, welt around MMR site. Patient was given albuterol nebulizer treatment and oral BENDRYL. Was given IM SOLUMEDROL: all symptoms resolved at time of discharge.
Heard doctor say give Menactra and Gardasil vaccines. I did not check well child visit sheet to double check doctor's documentation of same.
I was experiencing hearing loss; Extreme ringing in ears; Started after my first dose its making my life unberable; Having hard time consentrating at work; Headache; Extreme vertigo; Upon Follow up #2 (PRD19AUG2021/SRD 19AUG2021) case was considered valid suspect product "BNT162B2" was added.  This is a spontaneous report from a contactable consumer. A 32-years-old male patient received BNT162B2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: EW0150, Expiration date: 04May2021) dose 1 via unknown route of administration, administered in Arm Left on 05Apr2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient had past drug therapy with unspecified drug. Concomitant medication included excedrine (CAFFEINE; PARACETAMOL) dose of 300mg once a day for headache on 04May2021. The patient stated that he was experiencing hearing loss after getting the Pfizer shot (Unspecified shot) on 05Apr2021. The patient received treatment for the event. He illness before the time of vaccine having extreme ringing in the ears does not stop started after my first dose it's making my life unbearable having hard time concentrating at work used up all my sick time because of because of this also get headaches and extreme Vertigo. The patient reported that reported issue occurred after taking Pfizer product. The outcome of the event I was experiencing hearing loss was not recovered and other events was unknown.
Student got a second dose of Moderna on 04-29-2021on Left arm. It was not disclosed to us by student that he had the Janssen prior to this vaccination.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Psoriasis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by him was related to covid vaccine. The reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for SKYRIZI for the event(s) of SICK WITH COVID was not provided.  Company Comment: This is a spontaneous case concerns an adult male patient (age not specified), with no medical history, who experienced the unexpected non serious AESI event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. SARS-CoV-2 test was Positive on an unknown date. The Clinical course, Concomitant medication, treatment details were not provided, and the outcome of event reported as not resolved. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerns an adult male patient (age not specified), with no medical history, who experienced the unexpected non serious AESI event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. SARS-CoV-2 test was Positive on an unknown date. The Clinical course, Concomitant medication, treatment details were not provided, and the outcome of event reported as not resolved. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Started having chills, the evening after vax. Pt had elevated temp of 101, cough & lungs felt congested. Pt went to urgent care on 12/8/99 & was given an antibiotic injection & Rx for oral antibiotics.
Today 12/31/2020: Today wake up with sore itchy throat, headache, nasal congestion.
I was tired that morning and I had an appointment for a skin doctor so I went to that appointment, didn't think anything of it. The next day I was feeling nauseous but I just figured it was normal after the vaccine, and after I ate breakfast. I then threw up and had a lot of loose stool. These symptoms lasted a good 24 hours. No fever or chills, just a lot of fatigue and stomach issues.  After I had my 3rd shot I did not even have a reaction to it.  In January I came down with COVID, I tested positive right away.
Fever, headache, nausea, vomiting, body aches, fatigue, soreness at injection site for 24 hours
Bone pain, positional vertigo for a month and a half, now I notice memory forgetfulness, little concentration.
Gave KINRIX instead of PEDIARIX. KINRIX-Manufacturer GlaxoSmithKline. Lot # G352K. Route/site IM R-thigh.
Small raised bumps on lip; Swelling and itchiness on lip; Itchiness on lip; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in right arm on 18Sep2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in right arm on 26Aug2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 21Sep2021 at 07:00, the patient experienced small raised bumps on lip, followed by swelling and itchiness on lip. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events small raised bumps on lip, swelling and itchiness on lip was not resolved at the time of report.
MILD PAIN AT INJECTION SITE; RASH CAUSING PRICKLY PAIN; PINK RASH COVERING BOTH ARMS; DEVELOPED A RASH, PINK IN COLOR, THAT COVERED BOTH ARMS CAUSING CONTINUOUS PRICKLY PAIN AND ITCHINESS; This spontaneous report received from a patient concerned a female 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced rash causing prickly pain. On MAY-2021, the subject experienced pink rash covering both arms. On MAY-2021, the subject experienced developed a rash, pink in color, that covered both arms causing continuous prickly pain and itchiness. On an unspecified date, the subject experienced mild pain at injection site. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Positive antibodies for Covid-19. The action taken with covid-19 vaccine was not applicable. The patient recovered from mild pain at injection site, and the outcome of pink rash covering both arms, rash causing prickly pain and developed a rash, pink in color, that covered both arms causing continuous prickly pain and itchiness was not reported. This report was non-serious.
PATIENT COLLAPSED IN PARKING LOT AFTER WAITING HIS 15 MINUTES. HAD SHORTNESS OF BREATH AND LABORED BREATHING. HEART RATE WAS VERY FAINT AND PATIENT WAS SWEATING. WIFE STATED PATIENT DID NOT EAT YET TODAY
" I got a bump and rash on my left arm at the site of the injection on Friday. I also had a swollen lymph node on my left underarm."
10mo male with focal left side seizure in setting of fever that progressed to tonic-clonic seizure and prolonged for estimated 30-45min with prolonged post-ictal paralysis. Admitted for fluid hydration, monitoring, and evaluation.
Information has been received from a physician concerning a female with hypertension and a history of bronchitis, colitis and cerebrovascular accident, pain syndrome and anaphylaxis after penicillin and sulfa and allergies to Tylenol, Motrin, Darvocet and hydrocordone who on 25-SEP-2007 was vaccinated with ZOSTAVAX (Lot no. 658212/0887U).  About 1 week after vaccination (on approximately 02-OCT-2007) the patient developed generalized itching which was localized on her back and chest.  A biopsy showed non specific urticarial dermatitis.  She is non responsive to oral antihistamines, fenofexadine, zyrtec, xyzal, hydrozyzine and topical cortisone.  Physician was interested in PCR testing.  The patient sought medical attention, seen in office.  At the time of the reporting, the patient had not recovered.  The physician considered non-specific urticarial dermatitis to be an other important medical event.  Additional information has been requested.
18M with no PMH s/p pfizer vaccination dose 2 on 5/4/21 who presented with chest pain. He initially had chest pain the day prior to admission with pain in his back and down his left arm. This improved with Tylenol and resolved prior to bed. On the morning of 5/6 the chest pain returned and was so severe it woke him from sleep. He was difficult for him to characterize, but he said it was all over his chest, sometimes sharp and pressure-like, most severe in mid substernal region and was so substantial that he had difficulty speaking properly. He feels that the pain is most severe when lying flat and is best managed when he is resting at a 45 degree angle. Patient was at ED he was found to have an initial ECG with ST depressions in aVR and elevations in II, aVF, and V2 through V6 raising suspicion for pericarditis/myocarditis. Initial troponin was elevated at 4.35 as well. Cardiology Dr. was contacted by ED physician, case discussed, and EKGs reviewed and felt this was more likely pericarditis, but not STEMI. Of note, he reports a family history significant for his mother having a?hole in her heart.?He was given Toradol with improvement in his pain and upon arrival to hospital his chest pain was markedly improved.  He was noted to have troponins peaking at 39.415 that down trended and an elevated CRP of 4.8 on admission. D-dimer was 0.26. Covid PCR was negative.  He was evaluated by cardiology again here who upon review of his ECG and cardiac enzymes as well as presentation was consistent with pericarditis. Echocardiogram showed normal LV systolic function with trace posterior pericardial effusion and telemetry was monitored without any arrhythmias. He was started on low-dose beta-blockers, aspirin 650 mg 3 times a day, and colchicine 0.6 mg every 12 hours for 2 doses followed by 0.6 mg daily. He is planned to continue this for approximately 3 months and will need to follow-up with cardiology in 1 to 2 weeks for repeat monitoring and management with plan to taper off aspirin once his CRP normalizes.  Later that night, he even had a similar episode of sudden onset chest pain for which she received IV Toradol with minimal relief and oral Tylenol with relief of symptoms after that. No telemetry abnormalities were recorded at that time.   ECG the following day showed improving ST changes and troponin of 26.328 with CRP 4.2. He had no further symptoms for over 24 hours and is responding well to treatment.   He is advised to take Tylenol as needed in addition to the above-mentioned medicines should he have any recurrent chest pain.
About 4 days after being vaccinated, I started having random stinging pains in different areas of my legs, mostly back of calfs, behind knees and thighs; and my upper arms. Feeling of losing circulation to my legs occured, to the point they felt like they were falling aslleep. That would happen while standing, sitting, laying down. Numbess in lower extremeties. Its difficult to walk at times, especially from sitting to standing and walking. Feeling of loss of circuation would make it difficult.  I woke up a few days ago with my left hand, two fingers numb. Ive never had this occur before.
Received vaccine on Tuesday 3-17-15 and called to report swelling, redness, and tenderness at injection site Friday 3-20-15. Patient said swelling was size of apple or palm of her hand.
This was a 2nd dose of shingles vaccination.  No reaction to first dose.  2nd dose was Shingrix.  Not sure about 1st dose.  Reaction was as follows:  1) shivering in middle of night (2 or 3am); 2) early morning stomach pain; 3) woke to fever of 101.3, which remained for 6 to 8 hours, along with strong headache, heavy fatigue, and nausea.   Began to feel better around 3 or 4pm on Sat., Nov. 23.  Felt close to normal by bedtime that evening, and felt fine the next day.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 30-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Heart palpitations, wheezing, shortness of breath, swelling in upper lip, extreme lower abdominal cramps, urinary infection (visited urgent care a few days later for treatment)
Patient received the Covid vaccine in Left arm. Asked for a minute, then passed out and started seizing
Approximately, 5 min after pt. receiving the vaccines- while mother was talking to me and pt. was standing in the hallway, with syncopal episode. Pt. his head on scale, and was pale- lasted about 20-30 sec. Pt. was supported in Trendelenburg postion. As she started to come around for 5-6 sec-- passed out again. This time lasted about 2 min. Pt. had a seizure- stiffening of upper extremities. Was pale, but no cyanosis. + enuresis. When pt. came to, was very disoriented, and had no recollection of event. Pt. became very upset and anxious- crying. As pt. was observed- tolerated some water and licking of lollipop. Started to complain of headache and dizziness. Sent over to ER for evaluation. In ER- pt. had lab.
Presented to the ED today with altered mental status and depressed respirations. Wife reports she was unable to wake him up earlier this evening .States patient started feeling poorly on Saturday and has been getting progressively worse since then.
Began to feel itchy all over about 15 minutes after injection.  Patient reported that "it feels like when I work in the garden too long".  No other symptoms of anaphylaxis so treated with 25mg Benadryl, water, rest & observation for 30 more minutes. Itchiness resolved and patient was comfortable going home with additional info regarding when to seek additional care if needed.
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All    COVID VACCINE CLINIC  1/6/2021    Date:  1/6/2021                                                                                                Subjective Patient is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness, flushing and HA.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Hx: pt has history of breast CA and is on oral chemotherapy.      ALLERGY REVIEW OF SYSTEMS:  All other systems negative          Objective    Vitals Vitals:   01/06/21 1415 01/06/21 1427 01/06/21 1443 BP: (!) 168/89 (!) 154/94 (!) 154/84 Pulse: 87 85 72 SpO2: 99% 98% 99%     Physical Exam Vitals signs and nursing note reviewed.  Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Eyes:     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.   Pt was given Food and water and started to feel better.  For her headache she was given Tylenol 1000 mg orally. Pt left clinic at 2:45 pm.        Electronically Signed 1/6/2021 2:44 PM
This spontaneous report as received from a healthcare worker refers to a 29 patients of unknown age and gender. Concomitant therapy, pertinent medical history or drug reactions/allergies were not reported. On an unknown date the patients were vaccinated with GARDASIL (0.5 ml, intramuscularly) that underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
3:15 Vaccine administered. 3:30 Pt feeling light headed & arms tingly. 3:35 RN spoke to patient & she reported feeling better. 3:45 Pt decided that she'd prefer we call the ambulance. No SOB. Not faint. Pt feel very anxious perhaps. 3:55 Paramedics arrive.
itching, redness, all extremities and back "chest feels hot" diaphoretic VS @ 1818 103 HR, 198/125, 98% room air 50mg Benadryl administered PO @1818 VS @ 1838 93 HR, 175/116, 97% room air 1850 symptoms unresolved and increasing in intensity, increasingly diaphoretic. I wanted to send her to ED but she refused and walked out stating she would take a pepcid and self-medicate. I instructed her to call EMS if her symptoms do not resolve or she develops new symptoms. She verbalized understanding and left at 1851.
I got my first Covid-19 Vaccine on 6/16/2021 and noticed that for the rest of the day every hour or so I would get brain zaps. They went away by the time I woke up the next morning. On 7/16/2021 I received my second Covid-19 vaccine and the brain zaps came back only this time would happen a few times every minute. Once again, they went away by the time I woke up the next morning. I thought they were gone, but on January 31, 2022 they came back. This time happening a few time every second sometimes and I would have a brain zap when ever I swallowed. I figured they would go away by the time I woke up the next morning, but this time it lasted 2 days until I woke up February 2, 2022. It feels like a shock of electricity is hitting my brain on the right side. I went to the doctor on the 2nd of February and the doctor was shocked that I was experiencing this. He did not know what to do and referred me to a neurologist. I have not been to the neurologist yet.
I was sick for 6 day straight, flue like symptoms. fever for 3 days diarrhea for 5 days on my 3rd day nausea to the point of fainting and didn't know if i was going to throw up or more diarrhea. My body wouldn't allow me to do either for hours until the evening when I got fever and diarrhea again. Body aches and headaches for 5 days. chills like i was freezing in the evenings. it was absolutely horrible!