chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosis of confusion/ about 2 hours after vaccine she became disoriented, couldn't figure out how to get her seat belt on.  the next day she couldn't even dress herself; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, administered in Arm Left, at the age of 83-year-old, on 20Feb2021 13:15 as SINGLE DOSE, for covid-19 immunisation.  Medical history included seizure, cardiac disorder, diabetes mellitus, hypertension, blood cholesterol abnormal, and thyroid disorder. Patient is not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks and was not diagnosed with covid prior vaccination. Concomitant medications included trazodone, potassium chloride (KLOR CON), furosemide, irbesartan, levetiracetam, metformin hydrochloride (MEFORMIN), metoprolol, warfarin sodium (JANTOVEN), nitrofurantoin (NITROFUR), acetylsalicylic acid (BABY ASPIRIN), melatonin, levothyroxine, apoaequorin (PREVAGEN [APOAEQUORIN]), cyanocobalamin (B12 [CYANOCOBALAMIN]).  The patient previously took codeine linctus and experienced drug hypersensitivity, hydrochlorothiazide and experienced drug hypersensitivity.  On 20Feb2021 13:15, about 2 hours after vaccine, she became disoriented, couldn't figure out how to get her seat belt on.  The next day she couldn't even dress herself.  this onset was very sudden.  The patient was sent to a nursing home with the diagnosis of confusion.  The patient was hospitalized for 2 days in response to the event in 2021. The patient did not receive any treatment in response to the event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Feb2021, sars-cov-2 test: negative on 23Feb2021, sars-cov-2 test: negative on 01Mar2021.  Outcome was not recovered.  Information about lot/batch number has been requested.
Inflammation and itchiness around injection site appeared 10 days post dose 1. Lasted for 2days.
Within 5 mins of vaccine red spots around eyes, some redness by DTAP, influenza vaccine locations (sites). Given 25mg PO Benadryl. Seen by MD.
Pt was diagnosed with Covid-19 04-06-2021 and admitted to hospital with Covid-Pneumonia
Patient received shot on 10/11/12. Called Monday, 10/15/12, stating his arm was still sore & that it started to tingle "like when I got the shingles shot." Told pt if persist or gets worse call doctor.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Moderna vaccine on 1/13/2021, 2/10/2021, 10/15/2021 and 3/14/22. Presented to ED 09/12/22 w/increasing SOB and O2 needs. In ER, patient in afib RVR, HFNC 60L/60%, given IV MP 100, vanc/cefe, lasix, diltiazem gtt. Admitted for afib, Covid PNA and interstitial lung dx. Episodes of delirium w/decreased sleep, improved with nightly prn precedex. Cont'd increasing O2 demands,  eventually max'd on Airvo. Became increasingly tired, requested to change status to DNR. Expired on 9/17/22. Tx'd w/remdesivir, methylprednisolone, bactrim, doxycycline, vancomycin, cefepime, and acyclovir.
Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal response with near syncope episode.  Gave Diphenhydramine approximately 25 minutes after onset.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities, fatigue, muscle pain and headache. On an unknown date, the outcome of the erythema of extremities, fatigue, muscle pain and headache were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, fatigue, muscle pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX a few weeks before the date of reporting. In 2018, the patient experienced red arm, severe headache, fatigue and muscle aches which lasted over a week. The patient had been advised not to get the 2nd dose of SHINGRIX. The patient did not wish to provide additional information as her pharmacy had already reported her reactions to the health department. The patient wanted to know how much protection did she have from one dose of SHINGRIX.
I had cough, sore throat, fever of 100.5, chills, body aches, and wheezing. I tested positive for COVID-19 at home. I talked to my doctor, and he prescribed me Paxlovid. I still have a lingering cough.
Patient received vaccination at approx. 9:45 am, she was waiting afterward per protocol to ensure she was fine, however about 5 minutes passed and she came up to counter stating she did not feel so good, she was flushed and dizzy her heartrate was approx 100bpm
Metallic taste occurred roughly 15 mins after injection. Detected first mildly, then much more strongly on the tip of my tongue.  Within 1 and half hours, the taste is much stronger and has spread from the tip to the right side of tongue and roof of my mouth.   This was also the case (non-reported) for me during Covid I (lot number EW0164). In that instance, the taste lasted about 2 days and decreased significantly from onset approximately 24 hours later.
Myocarditis; ASSESSMENT OF RISK FACTORS FOR MYOCARDITIS (US) USING ELECTRONIC HEALTH RECORDS AND CLAIMS DATA  This is a non-interventional study report received from a contactable reporter(s) (Other HCP) for protocol C4591055.  An adolescent male patient received BNT162b2 (BNT162B2), on 16Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "chronic otitis media" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization), outcome "recovering". The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: (20Jul2021) 340, notes: stated in note as elevated; Blood creatine phosphokinase MB: (20Jul2021) 11.8, notes: stated in note as elevated; C-reactive protein: (20Jul2021) 3.4, notes: stated in note as elevated; Magnetic resonance imaging: (22Jul2021) normal biventricular size and systolic function., notes: 2. Moderate myocardial edema of the basal segments of the left ventricle, particularly along the inferolateral segment; Troponin: (20Jul2021) 2624, notes: stated in note as elevated. Clinical information: The patient presented with chest pain, tachycardia and elevated troponins as well as other elevated enzymes 4 days after his second Pfizer Covid vaccination. Discharge Diagnosis: Myocarditis due to COVID vaccine-Pfizer COVID vaccine. Patient's Race: Unknown. Patient's Ethnicity: Unknown. Study Drug (Trade and Generic), Formulation, Route, Indication: Pfizer Covid-19 Vaccine 2nd dose; Dose: UNK; Units: UNK; Frequency: 1. Concomitant Drugs: Unknown. The investigator considered there was a reasonable possibility that the event was related to study drug (Pfizer Covid-19 Vaccine - 2nd dose), there was not a reasonable possibility that the event was related to concomitant drug.  The reporter considered "myocarditis" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported event myocarditis cannot be excluded based on temporal profile and known safety profile of suspect product.
PNEUMOVAX arm 1/18/10, arm became red swollen and tender that evening.  Soreness at inj site persisted 9 days.
My daughters arm has become hard and swollen an hot to the touch. At first it was just at the injection site and now it has spread to her entire upper am.
Patient became bradycardic and went in and out of consciousness. EMT took patient to private area to access and EMS was notified to to take to ER.
Headache, fever, chills, muscle aches, shivers, constipation, sweating.
Sharp pains in stomach, hip, and back muscles aprroximately 32 hours after vaccine.  Spasms in stomach continue to date, as do weakness in legs to the point of using a walker to get arounds, and an overall feeling of unwellness.  Have had no fever.  Contacted personal physician 8 days after vaccine and was advised to take Tylenol, which I have been doing for a few days, but am now taking consistently every 8 hours as directed.
8 year old female patient was given expired dose of IPOL vaccine, with no reported adverse event; Initial information received on 21-Jul-2021 regarding an unsolicited valid non-serious case from a other health professional via physician via Agency (Reference number- 00691611).  This case involves a 8 year old female patient who was vaccinated with the expired dose of suspect IPV (VERO) [IPOL]. Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 19-Jul-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot R1D973M and expiry date: 17-Jul-2021) (Frequency: once) via an intramuscular route in the right arm (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At the time of reporting, no adverse event was reported.  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.
Pt allergic to vaccine Rash covered whole back. Arm swollen at site of injection. Pain & rash
fever and chills; Body aches; Forgetting stuff worsening; Forgetting stuff worsening; low Covid -19 antibody after receiving Covid-19 Vaccine; headache; fever and chills; This is a spontaneous report from a contactable consumer or other non hcp (patient) and Other HCP. A 48-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation; teriflunomide (AUBAGIO), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for multiple sclerosis. Medical history included ongoing allergies (hypersensitivity), ongoing GERD (Gastro oesophageal reflux disease), ongoing covid-19 pneumonia, ongoing jc virus infection, ongoing multiple sclerosis, ongoing migraine, ongoing nerve pain. Concomitant medications included gabapentin (GABAPENTIN); omeprazole (PROTONIX [OMEPRAZOLE]); azelastine (AZELASTINE); mometasone furoate (FLONASE [MOMETASONE FUROATE]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. On 18Mar2021 the patient experienced fever and chills, body aches, forgetting stuff worsening, condition aggravated, low covid -19 antibody after receiving covid-19 vaccine, headache. Following the first dose intake of Teriflunomide and bnt162b2. It was not reported if the patient received a corrective treatment for the adverse events. The action taken in response to the events for teriflunomide was unknown. At time of reporting, the outcome of all the events was resolved on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced shingles 10 weeks after receiving the Shingrix No vaccines data was provided. The reporter consented to follow up.
[Pfizer Covid 19 booster vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Pfizer Covid 19 Booster - Patient reported, while on Ambrisentan, that she had tooth sensitivity that increased when she had the Pfizer Covid booster vaccine. She also reported that she had headache each day as well, until she was taken off of Tadalafil.
22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck.  Took benedryl and pepcid at home OTC.  The next morning woke up with hives, flushed feeling, and chest/throat tightening.  Went to the ER was administered iv medications.  Went home.  4 Hours later started again with chest and throat tightening and swelling of the eyes.  Kept having break through reactions when medications were wearing off.  The ER md that I saw called in some home medications that I started taking.  Pepcid and Prednisone.  7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.
pt recv vax; he presented w/ a 6x6 area of swelling and fever of 101; this is one of 3 patients from the same site and lot number to exp these rxn;
numbness to the tip of tonge; cramps to the tip of tongue; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA ORAL (numbness to the tip of tonge) and TONGUE SPASM (cramps to the tip of tongue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:42 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced TONGUE SPASM (cramps to the tip of tongue). On 07-Jan-2021 at 11:32 AM, the patient experienced HYPOAESTHESIA ORAL (numbness to the tip of tonge). At the time of the report, HYPOAESTHESIA ORAL (numbness to the tip of tonge) and TONGUE SPASM (cramps to the tip of tongue) had not resolved.        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.   No concomitant medications were reported.  Treatment details were not reported by the reporter.; 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.
Approx 3-4 hrs following DTP/OPV immun 28MAY91, mom noted complete limpness of the pt approx 5 minutes;
Patient was vaccinated at the age of 17  The recommended age is 18  No adverse reaction was reported
Very dry throt, chocking, chill. body shacking, chest tightness, twinging in arm and legs, Visit Emergency room for 3 time ( around every 8 days) test - X-ray for chest, Neck,  CTC - chest, neck, head CTA- neck, head MRI - neck, head telescope to check throt by ENT  visit to  - ER 3 time, admitted to hospital at 3rd time,  visit to ENT, GI, Polemology, Neurology, Symptoms still as is, little better than before.
Pt recv vax on 11/9/98; on 11/10/98 pt exp red, swollen, warm vax site
I was tired; headache on the left side of his head/stroke-like headache on left side of his head (in the temple)/headache, a throbbing the size of a quarter on the left side of my head; He feels a slight pressure with his headache; I have been experiencing a little lumps, it feels like a little lumps inside like "hard" (not clarified) in my head just one side of the head is stopped.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 65 years of age), dose 1 via an unspecified route of administration on 05Mar2021 11:30 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first Pfizer COVID-19 vaccine on Friday (05Mar2021) and on 10Mar2021 he had a stroke-like headache on the left side of his head (in the temple). He felt a slight pressure with his headache and he was not sure whether this was a sinus pressure. He wanted to know if this had been reported with the Pfizer COVID-19 vaccine. He also wanted to know if stroke was an AE related to the Pfizer COVID-19 vaccine. He wanted to know if he could take Tylenol after getting the vaccine. Two weeks after the vaccine, the patient had been experiencing a little lumps, it felt like a little lumps inside like "hard" (not clarified) in his head just one side of the head was stopped. He queried if it was a side effects with Pfizer shot. He clarified that he had it on 05Mar2021, he got it all in the March. He queried if that was part of side effects from the shot he had, a sort of side effects part in his head. It was reaction he believed, he doesn't think it was nothing else, he didn't have it before, he didn't have before the 5Mar2021. He didn't have by initially by all 8-9 days, going on 2 weeks now. He just wanted to know if these are one of the side effects. The one, he wanted to know if the sort of side effects inside of his head. The events are reported non-serious. On 26Mar2021, it was reported that patient was supposed to get his 2nd dose today. He added that on 13Mar2021, he was tired, but also had a headache, a throbbing the size of a quarter on the left side of his head, it did not increase in pain it was moderate in pain and it was on and off, which he still have. He asked if it was common. He mentioned that he saw his doctor and was prescribed Naprosyn 500mg which he takes 4-5 times and it didn't do anything, it might went away but came back again. He was supposed to have an ultrasound in April 2021. He asked if he had sinus issue, will that be a problem to get his second dose. Therapeutic measures were taken as a result of headache. The outcome of headache was not recovered while unknown for other events.   Information on lot number/batch number has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL9261) and on 22Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FE3594) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Test negative for antigen at day 7; (08Jan2021) Positive, notes: Treatment of COVID-19; (29Jul2022) Positive, notes: test positive today 29Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19 and was treated with Paxlovid from 15Jul2022 to 20Jul2022.  Clinical Information: Rebound 10 days after initial dose. Test negative for antigen at day 7; test positive on 29Jul. Symptoms runny nose.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
One week after receiving my second shingrix vaccine I experienced left sided facial numbness with tingling a slight pain. I went to my dentist and was examined, had a x-ray that was normal. The interior left side of my cheek was swollen to the size of half a golf ball, I was referred to an oral surgeon who has referred me to a neurologist. I had a brain mri with contrast focusing on my cranial nerves, everything  was fine. I am a retired nurse and feel as this may be related to my vaccine. A nurse practioner that worked with me just informed me that right after her shingrex vaccine she is have numbness and slight pain on part of her lower left arm. I just wondering if these symptoms are related to the vaccine...I am baffled.  Thank you.
My wife and I were on an overseas trip we had received a prescription of Paxlovid from our PCP as prevention. On 11/01/22 I had a sore throat, that by 11/02/22 it started to get worse I tested on 11/03/22 with a home COVID-19 test that came back positive. I started taking the Paxlovid immediately. The first two days were the worst, then I started to feel better. By that Tuesday I was feeling much better.