chrisvoncsefalvay/vaers-outcomes huggingface dataset:
28OCT crying most of night p/inject, t102; 29OCT91 went to MD given APAP-MD said rxn to immun; 1NOV91 blisters in mouth;
Patient states that after receiving the 3rd dose Booster Pfizer 09/29/2021, started experiencing symptoms 10/01/2021 of rash across the back and abdominal area. Primary communications 10/01/2021 suggested self-treating with Benadryl. No other symptoms noted.
pt recvd vax & 30-60 mins later felt hot, sweaty, & weak; The duration of these sx was short;
Recipient received the vaccine and was waiting in the observation area.  Around 10 minutes, felt hot and dizzy and then lost consciousness for less than 10 seconds. She did not fall on the floor.  Moved her to the cot and called emergency responders. She said she had not eaten anything that day nor had any water. Gave her water and a granola bar. EMS evaluated her and she wanted to go to the ED for further evaluation.
Numbness of tongue on 10/14/2013. On 10/17/2013 facial paralysis on the right side.
Vaccinator attempted to administer the Pfizer vaccine into the patient's right arm, as the vaccinator began to engage the plunger of the  syringe, the dose leaked out of the end of the syringe and dripped down the patients arm. After speaking with the provider, a second dose was deemed to be necessary and successfully administered to patient.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 25-Oct-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805545 was crossed linked to original cases 201804863 due to same reporter.
Varivax Local reaction at injection site - approximately 4 cm x 5 cm pink, puffy, warm, pruritic
Limited range of motion in arm; Pain continuing, now six weeks past injection date; Excessive discomfort causing inability to sleep through night.
lt arm swollen, red, knot, mildly tender, sl induration, erythema 8cm;tx use DPH, local heat;
Increased menstrual bleeding  Heavy and prolonged bleeding more than normal.  Clots coming out during bleeding
Tightness of chest, lungs burning, tingling of lips, sensation of throat closing up. Difficulty breathing. Dizziness, weakness, hives near injection site. Swollen itchy eyes, face numbing. Chills, mild fever, reduced oxygen saturation. Wheezing & hoarseness. Pale in face. Took two BENADRYL, drank a ton of water, and monitored vital signs at home. Severe chills in the middle of the night, extreme dizziness, and dehydration. Probably should have gone to the hospital, but husband is a nurse so had him monitor vital signs instead of going to the hospital.
chills; swelling to left arm at the injection site; redness to injection site; heat to injection site; felt hot inside; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot inside), CHILLS (chills), VACCINATION SITE SWELLING (swelling to left arm at the injection site), VACCINATION SITE ERYTHEMA (redness to injection site) and VACCINATION SITE WARMTH (heat to injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING HOT (felt hot inside). On 06-Apr-2021, the patient experienced CHILLS (chills), VACCINATION SITE SWELLING (swelling to left arm at the injection site), VACCINATION SITE ERYTHEMA (redness to injection site) and VACCINATION SITE WARMTH (heat to injection site). At the time of the report, FEELING HOT (felt hot inside), CHILLS (chills), VACCINATION SITE SWELLING (swelling to left arm at the injection site), VACCINATION SITE ERYTHEMA (redness to injection site) and VACCINATION SITE WARMTH (heat to injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medicine has been reported by reporter.
Swelling, redness and itchiness. The swelling improved after 3 weeks. Treated with Benadryl by parents.
Inconsolable crying > 5 hours. Encouraged parents to seek medical attention from pediatrician.
get a rash all over; swelling of the extremities; very itchy; DOSE 3 (BOOSTER) SINGLE; DOSE 3 (BOOSTER) SINGLE; This is a spontaneous report from a contactable other hcp (patient). A 19-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2), dose 3 intramuscular, administered in Arm Right on 07Oct2021 10:00 (Batch/Lot Number: 301308A) at the 19-years-old as DOSE 3 (BOOSTER) SINGLE, for covid-19 immunisation. Medical history included Covid-19. Concomitant medication included influenza vaccine (FLU) taken for immunisation on 27Sep2021; medroxyprogesterone acetate (DEPO PROVERA) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2 on 05Feb2021 at the age of 19-year-old for Covid-19 Immunization (Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Right Arm, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular); and BNT162B2 on 15Jan2021 at the age of 19-year-old for Covid-19 Immunization (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Right Arm, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular). The most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The patient experienced get a rash all over, swelling of the extremities, very itchy on 07Oct2021 10:30 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19: diagnosed with covid-19 on an unknown date (Prior to vaccination). The patient started to get a rash all over and had swelling of the extremities. The patient became very itchy, was given 25mg of Benadryl to try and reverse the itching and rash. She was still feeling itchy and have some. No hospitalization Prolonged. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Rash, Peripheral swelling, Pruritus and the suspect drug BNT162B2 cannot be excluded. The case will be re-assessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Tired about 7 hours after vaccine, minimal pain in injection site. 2am- fever Next day- high fever, high heart rate. Currently 2nd day after administered and seen again by healthcare professional) high fever, high heart rate, lovalized reaction to injection site- major swelling, moderate pain, muscle spasms.
Acute myocardial infarction LAD proximal, requiring thrombectomy. Unremarkable lipid profile, no other risk factors for CAD other than age.
Swelling at injection site, very tender to the touch for 2-3 days after injection. Arm sore after injection.  On day 16 arm extremely itchy at injection site. I can still feel a lump at the injection site although it has gotten smaller.
I couldn't sleep at night, because I could not lay not my right side it was throbbing and extremely sore, the side of my injection. I could not raise my arms to put my shirt on, wash my hair, even lift a copy of coffee. Taking off my shirts, bras, and tops are a struggle. The moment I use my right arm, there is pain, especially any movements that requires using my rotator cuff muscles. Even moving my arm from my mouse to the key boards cause my upper right arm pain. The symptoms started a the next day, when I woke up, my arm just didn't feel right, it was not the typical soreness you get with a flu shot that last for a few days. At the time I am writing this, it is now almost 2 1/2 weeks. I still cannot lift my right arm without pain. I don't sleep well to begin with, and now I hardly get any rest. I have seen a doctor and he has referred me to an orthopedic doctor, which I will see today.
Information has been received from an nurse concerning a 21 year old female with allergic reaction to antibiotics (Septra) who on 01 Dec 2006 was vaccinated intramuscularly in the left deltoid with HPV vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On 01 Dec 2006 about three hours post vaccination the patient developed blurry vision in her left eye. No other symptoms were reported. Unspecified medical attention was sought. At the time of this report the patient had not recovered from the blurry vision. Additional information has been requested.
Client sts that he received his 2nd covid vaccine of Pfizer at the Health Department. He sts that he started having onset of severe headache/pressure in head, painful bilateral eye movement and noticed that he has a "swollen lymph node" on the left upper clavicle/neck area. Client sts that this swollen area is palpable, but not painful to touch. He denies any difficulty in breathing, swelling to mouth. sts that his s/s were more severe on 5/19 and 5/20, and seemed to feel slightly better as of today, 5/21.
This spontaneous report as received from a patient's wife refers to a 66 years old male patient with asthma, high blood pressure. bladder dysfunction (patient's bladder did not empty by itself) and LEVAQUIN allergy. On 02-AUG-2014 the patient was vaccinated with ZOSTAVAX (injection, one time vaccine, lot # and expiry date were not reported). Concomitant therapy included unspecified blood pressure medication, daily sulfur medication to prevent bladder infection and unspecified asthma medication. ON 03-AUG-2014, the next day after getting a vaccine, the patient noticed that discomfort was gone but the lump remained, still pink at injection site, two inches around at site of injection. IT was reported that blood test and urine test were performed few weeks ago (in 2014), which came back fine. It was reported that no treatment was given to the patient. The patient did not seek medical attention. The relatedness between ZOSTAVAX, discomfort and lump still pink at injection site, two inches around at site of injection was not reported. Additional information has been requested.
pt recvd flu vax on 8OCT92 approx 8 hrs later exp swelling & pain in the arm of inject; next day devel numbness & was unable to use rt arm & hand; blood sugars became elevated to greater than 500mg%; pt seen in ER w/n,d, abdo cramps, pain;
Two days post vax, the pt complained of redness and warmth in right upper arm from shoulder to above elbow. Most tender at shot site. Advised to use warm packs to area for 2-4 days.
side effects last; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects last) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects last). At the time of the report, VACCINATION COMPLICATION (side effects last) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.    Reporter did not allow further contact
Symptoms started about 5 hours after injection, feeling faint and light headed, dizzy, chills, fatigue, arm pain at injection site, rapid heart rate, chest tightness, patient went to ER to receive treatment (IV, ativan, Tylenol, vistaril)
Swollen, hardened, reddened area approx 3 inches around site the day after injection (Oct 11th). On October 12th, area still hardened, less swollen, but temp of 101.
patient had received a Flu shot (Fluad) x 3 strains older on 16Sep2019 and Fluzone HD on 03oct2019, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 73 years old female patient who received vaccine INFLUENZA VACCINE INACT SAG 3V [FLUAD] (lot 260389 via unknown route in unknown administration site) on 16-Sep-2019 and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ252AA, Exp. Date 04-May-2020 via unknown route in the left deltoid) on 03-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to extra dose administered.  It was reported that she gave a Fluzone HD on 03-Oct-2019 during a vaccine visit only. Even though the Fluzone HD was appropriate for her age the caller asked if she had received any vaccines recently and the patient stated "No". Caller saw information after injecting the Fluzone HD that patient had received a Flu shot (Fluad) x 3 strains for patient 65 years old and older on 16-Sep-2019.   At the time of reporting, no adverse reactions were 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 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.  List of documents held by sender: none.
This is a spontaneous report from a contactable consumer. A 20-years-old female patient of an unspecified ethnicity received the second dose of TRUMENBA, via an unspecified route of administration on 28Dec2015 at single dose. The patient medical history and concomitant medications were not reported. The patient received the first dose of vaccine in Aug2015. The patient experienced warmth, redness, swelling of the injection site, and the site was tender all on an unspecified date with outcome of unknown.
4th moderna booster received (bivalent) in PM, 2 mornings later had swelling of lip filler sites, whch was place 2 month prior, 2 days after that began with B/L wrist, hands, feet, ankle, SI and neck pain stiffness and swelling, with myalgias of calves and forearms B/L. Lip swelling improved in 1 day - took cetirizine. Arthralgia and myalgias w/ only mild/temporary relief with ibuprofen and Flexeril. Seems to have resolved with Medrol dosepak.
Patient received Jansen vaccine on 04/01/2021. She reports on 04/10/2021 her left forearm started to itch. She described her left lower arm are slightly swollen,  warm to touch, reddened, and has some blister. She also has slight fever. She took Benadryl for itching. She denies left arm pain and limited of motion. She was given Medrol Pack and Cephalexin 500 mg every 6 hours for 10 days on 04/12/2021. Advised to returned for follow up for blood works and ultrasound of the left arm.
Starting the Friday following the immunization (2 days after), patient started running a fever of 100-102 consistently even while taking Tylenol.  This continued for 4 days and even still on Monday when she called to report it.  She also developed a sore throat and lost her voice  temporarily on Sunday.
h/a on top of head, w/joint aches & low grade fever;sl productive cough;From follow-up of September 15, 1997, "previously submitted over 1 year ago. Can not recall patient's name to look up information." From follow-up of February 29, 1996 reportedly the patient recovered from this experience. It was reported, "RABIES vaccine series was not completed. Had RABIES antibody drawn December 13, 1996, results > 8.0 IU/ml - NYS Dept of Health." From corresondence received on 24-May-2000, no additional information was provided. No further information is expected, this case is closed.
Went to the hospital after passing out 3 times a few hours after receiving the 2nd dose. Then experienced rapid heart rate and anxiety episodes reoccurring on and off for 3 weeks after receiving the vaccine.
Pain Abdominal: Pt reports that he has had left upper quad pain since yesterday. Reports pain was getting progressively worse. Orignally pt reports he thought he had pulled a muscle, but now doubts that.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications were reported. 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                 No treatment information was reported. This case is for the 15th patient out of 27 adult patients described by the reporter.
G47.33 OBSTRUCTIVE SLEEP APNEA 1/27/2023 COLON CANCER, SIGMOID
Dizzy, wobbly-couldn't walk, pale, lips turned blue. Heart rate dropped low had irregular heart beat. Sugar low immediately following mist (going for 2nd opinion).
COMPLICATIONS FROM THE COVID VACCINE; PSORIASIS FLARE UPS AGAIN; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COMPLICATIONS FROM THE COVID VACCINE) and PSORIASIS (PSORIASIS FLARE UPS AGAIN) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient experienced VACCINATION COMPLICATION (COMPLICATIONS FROM THE COVID VACCINE) and PSORIASIS (PSORIASIS FLARE UPS AGAIN). At the time of the report, VACCINATION COMPLICATION (COMPLICATIONS FROM THE COVID VACCINE) outcome was unknown and PSORIASIS (PSORIASIS FLARE UPS AGAIN) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medications were not reported.   It was unknown if patient was enrolled in COVID-19 vaccine trial. Treatment medications were not reported.
Troponins over 3000, Myocarditis, Heart Cath, MRI, Chest X-Ray, Patient has 0 family history or personal of heart issues, no alcohol, smoking or drug usage, CBC W/differential, Magnesium, Comprehensive Metabolic Panel, Influenza A,B, Covid-19, Respiratory Virus Antigens Profile, UA W/Microscopic, EGD, Colonoscopy,  C-Reactive protein, ECG 12 Lead, Basci Metabolic Panel, Phosphorus, Sedimentation rate, Protime W/INNR, APTT, Thyroid stimulating hormone, Toxicology Screen, Urine, Glyco HGB,  Lipase, CT,
Red, splotchy, sometimes itchy rash about 1-2 inches wide and 4-5 inches long that appeared about 1 week after 1st shot on upper left arm near injection site..  A small bump has since disappeared. This is day 3.
Death certifcate states cause of death to be SIDS. This is confirmed by autopsy results.
Patient is a 66 year old male with diabetes and a recent history of stent placement on who received a dose of Johnson & Johnson COVID vaccine today (6/29/21). He also has a history of rash with soma. He was doing okay and talking to the nurse for 10 minutes post vaccine when he became unresponsive mid-sentence. After 1-2 minutes, he started to respond again, and noted that he felt his throat momentarily closed. However, sensation gradually improved. No nausea, vomiting, weakness on one side. After 20 more minutes of waiting, he reports his throat sensation has returned to normal.
was diagnosis with COVID-19 through nasopharyngeal swab today, 02Jan2021; was diagnosis with COVID-19 through nasopharyngeal swab today, 02Jan2021; This is a spontaneous report from a contactable pharmacist (patient himself).  A 34-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EJ1685, expiry date not reported), via an unspecified route of administration in his right arm on 23Dec2020 15:30 at single dose, for Covid-19 vaccination. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included bupropion. The patient informed that he was diagnosed with Covid-19 through nasopharyngeal swab (COVID-19 Nucleic Acid Amplification test) on 02Jan2021 01:00 and Influenza virus test was unknown results (02Jan2021). It was unknown if there was a treatment used. The outcome of event was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information